Clinical Research Directory

Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers

The goal of the MYSSELF study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.

Avera Cancer Sequencing and Analytics Protocol (ASAP)

The purpose of this study is to characterize the breadth of molecular features present in participants receiving care within a large, integrated, community-based healthcare system. Through comprehensive genomic profiling, investigators aim to identify the underlying genomic drivers of premalignant and malignant conditions across a range of disease stages and cancer types. Comprehensive molecular profiling will include somatic tumor testing (tissue and/or blood) using next-generation sequencing. Selected subsets of samples may undergo whole exome and/or whole transcriptome sequencing for research purposes. Pharmacogenomic testing will also be performed to better understand individual variability in medication response and to identify opportunities for optimizing treatment. In addition, participants may optionally provide microbiome samples. To maximize the value of the genomic data, participants who consent to this protocol will have their electronic health records-both retrospective and prospective-abstracted, curated, annotated, and linked to the genomic data generated through study testing. Given the long-term value of these data, participants may also voluntarily consent to the storage of their biological samples in a biobank and to the use of their de-identified information for future research. Data collected from this participant population will support efforts to advance the understanding of cancer biology, as well as the discovery and validation of biomarkers associated with clinical outcomes. Findings may also be shared through collaborative research initiatives to further promote advancements in cancer research.

Diagnostic Performance of an AI-Based Multi-Omics Model for Early Lung Cancer

This is a prospective, multicenter observational cohort study for patients with lung nodules suspicious for early-stage lung cancer. The study aims to build AI-assisted diagnostic models by integrating clinical data, CT imaging and multi-omics biomarkers, and validate a rapid evaluation system for bronchoscopic biopsy specimens. No investigational drugs or devices will be applied; all participants receive routine clinical care. We will collect clinical records, CT images, blood and tissue samples, and conduct long-term follow-up of disease outcomes. A total of 1050 subjects will be enrolled from 8 participating hospitals in China.

Breast Ultrasound Screening in Elderly Women: A Multicenter Cluster Randomized Trial

This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Approximately 80,000 women in Jiangsu Province, China, will be enrolled and followed for breast cancer outcomes.

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)

Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines. This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling. Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study. The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.

Understanding Information Preferences, Risk Perceptions, and Tradeoffs When Making Decisions About Multi-cancer Early Detection Tests

The goal of this clinical trial is to learn what people's informational preferences and risk perceptions are in regards to the use of multi-cancer early detection (MCED) tests. Participants will be asked to review three informational factors about MCED tests and complete a survey about their intentions to use an MCED test. Some participants will also be asked to complete an interview.

Screening Cancer Readiness Through Education and Empowerment for Newcomer Women

Purpose: This study was conducted to determine the effect of an online educational intervention on migrant women's knowledge and attitudes toward cancer screening. DesigN:This study was designed as a two-arm, parallel-group, randomized controlled trial with pre-test and post-test assessments. Method: The study population will consist of women registered at the Cancer Early Diagnosis, Screening and Training Center (KETEM) affiliated with the Erzincan Provincial Health Directorate. The sample size was calculated based on a two-group (intervention and control) and two-measurement (pre-test and post-test) study design. Using repeated-measures ANOVA with a medium effect size (d = 0.25), a significance level of 5% (α = 0.05), and a statistical power of 80% (1 - β = 0.80), the required sample size was determined to be 34 participants per group (34 in the intervention group and 34 in the control group), resulting in a minimum total sample of 68 participants. To account for potential attrition, it was planned to recruit 80 participants (approximately 20% more than the minimum required sample size).

Methylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles. This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging. The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.

Structured Case-Finding for Pancreatic Ductal Adenocarcinoma in Swiss Primary Care: A Feasibility Study

Pancreatic ductal adenocarcinoma (PDAC) is diagnosed at an advanced, incurable stage in more than 80% of cases in Switzerland. Certain warning signs - new-onset diabetes, unexplained weight loss, or a family history of pancreatic cancer - may indicate elevated risk, but are not systematically assessed in primary care. PANCATCH-Pilot tests whether a structured case-finding pathway in Swiss general practices is feasible. Adults aged 60 years or older with one or more of these risk factors are invited to undergo an MRI/MRCP examination of the pancreas and a blood draw for a blinded biomarker test (PancreaSure, Immunovia Inc.). Findings are reviewed by a multidisciplinary tumour board. The goal is not treatment, but to assess whether such a pathway works in the Swiss primary care context - as preparation for a larger national study. The study enrolls 50 trigger-positive participants over 24 months through two parallel recruitment pathways: GP referral and self-presentation via a study website. Feasibility is assessed using six combined endpoints covering recruitment, process quality, safety, and equity.

Epigenetic Signature for CRC Early Detection

The epiCED is a noninvasive blood-based assay designed for early detection of colorectal cancer (CRC) using circulating cell-free DNA (cfDNA) 5-methylcytosine (5mC) and 5-hydroxymethylcytosine (5hmC) epigenetic markers. This study leverages retrospective, multi-center cohorts of CRC patients and non-cancer controls to discover and validate a robust cfDNA methylation signature. Small-scale sequencing and machine learning-based modeling will be applied to identify a minimal panel of methylation markers that can accurately discriminate CRC from non-cancer individuals, including early-stage disease. The ultimate goal is to develop a clinically practical, noninvasive screening tool that enables population-level early detection and improves patient outcomes.

Default Option Nudging Intervention to Improve the Adherence Rates of Cancer Screening

The goal of this clinical trial is to learn if a behavioral "nudge" strategy, specifically a default option, can improve screening participation in populations at high risk for lung and stomach cancer. The main questions it aims to answer are: 1. Does presenting a screening appointment as a default option increase the likelihood that high-risk individuals will choose to be screened? 2. How do participants react, and what is their level of acceptance, when the nudge intervention is disclosed to them? 3. Does this transparency (disclosing the nudge) change their subsequent screening decisions? Researchers will compare a default option group to a standard control group to see if the nudge effectively increases screening adherence. Participants will: 1. Read a short educational text about lung or stomach cancer and its screening. 2. Complete an online questionnaire. 3. Make a decision regarding a simulated cancer screening appointment. 4. Read a disclosure explaining the behavioral nudge strategy used during the study. 5. Re-evaluate their screening decision and answer questions regarding their attitude toward the nudge.

Impact of SMS Messaging on Participation in Colorectal Cancer Screening

Colorectal cancer is a leading cause of mortality in Catalonia. Although early detection programs using the fecal immunochemical test (FIT) are effective in reducing both incidence and mortality, their success relies on high population participation. Currently, in the Vallès Occidental region, the participation rate stands at 42%, which is below the 65% minimum recommended by European health authorities. The objective of this randomized controlled trial is to evaluate whether sending a reminder text message (SMS) is an effective tool to increase participation in the screening program. The study will include 10,084 participants aged between 50 and 69 years. Half of the participants will receive a reminder SMS five weeks after their initial invitation, while the other half will follow the standard of care involving postal letters. Researchers anticipate that this strategy will not only increase the number of individuals undergoing screening but also shorten the response time and reduce the need for sending postal reminders

Trial to Evaluate the Impact of Various Pragmatic Interventions to Increase Mammography Uptake Among Defaulted Repeat Screeners in Singapore

Breast cancer is the most common cancer among women in Singapore, accounting for nearly 30% of all female cancers. While regular biennial mammography can reduce mortality, screening rates in Singapore remain low at 34.7%; well below the 70% threshold required for population-level impact. Despite a national screening program in place since 2002, uptake continues to be hindered by psychological, cultural, and logistical barriers. Although various studies have explored different behavioural interventions to boost mammogram uptake; ranging from reminders (traditional mailers, phone calls, text messages) and education to financial incentives, their effectiveness varies by population and context. Furthermore, few large-scale, prospective studies have been conducted locally. Prior research in Singapore is either outdated or limited in scope, and there is a particular lack of rigorous trials evaluating behavioral interventions tailored to women who have defaulted on screening, who faces distinct psychological and behavioral barriers; ranging from low perceived risk and fear, to false reassurance from prior normal results or lack of reminders, or had bad experience (procedural pain or prior false positive results) during last mammogram. Engaging these women is critical, yet challenging, and failure to do so undermines efforts to achieve broad population coverage. The REMIND Study addresses this critical gap by evaluating five pragmatic and scalable outreach strategies to increase mammogram uptake among women who had their last screening more than 2 years ago and are currently overdue. Through a large, randomized controlled trial, the study will generate much-needed local evidence on what works to reengage these women. Findings will directly inform national screening policies and the design of future outreach efforts tailored to Singapore's diverse population.

Menstrual Cup for Early Endometrial Cancer Detection in Lynch Syndrome

Study Goal: This pilot study wants to find out if using a menstrual cup can be a good, non-invasive way to collect samples from the lining of the uterus (called the endometrium) to help screen for endometrial cancer. This is especially important for women who have a higher chance of getting this cancer, such as those with a genetic condition called Lynch syndrome. Main Questions the Study Will Answer: 1. Can a menstrual cup collect enough uterine lining (endometrial tissue) for doctors to examine under a microscope? 2. Are the samples from the menstrual cup as useful for diagnosis as samples taken using the usual method (called an endometrial biopsy or EMB)? 3. Is using a menstrual cup at home easy, effective, and comfortable for participants? 4. Can scientists grow small lab models of the uterus (called organoids) from the menstrual cup samples and from biopsy samples? What Will Happen in the Study: * Participants will use a menstrual cup at home to collect menstrual blood. * They will also have a standard endometrial biopsy done by a healthcare provider. * After both collections, participants will fill out a short survey about how comfortable and easy it was to use the menstrual cup. What the Study Will Measure: * Feasibility: How well participants are able to use the menstrual cup and send in the sample. * Sample Quality: Whether the menstrual cup collects enough good-quality tissue for testing, and how it compares to biopsy samples. * Participant Experience: How women feel about using the menstrual cup, based on the survey. * Lab Testing: Whether researchers can successfully grow endometrial organoids from both types of samples. Why This Study Matters: If this method works, it could offer a gentler, more convenient way for women to get checked for endometrial cancer-especially those who need regular screening. It could also make it easier to collect samples for research and improve early detection of cancer.

Strategies to Decentralize Breast Ultrasound in Rwanda

Diagnosing breast cancer early is critical to reduce preventable breast cancer deaths in sub-Saharan Africa. This can be done in part through increasing patients' access to breast ultrasound, which is essential for evaluating breast masses. However, ultrasound is typically provided only by radiologists at urban referral hospitals. Training clinicians at rural district hospitals who are not radiologists could increase patients' access to breast ultrasound, but strategies to support and supervise these clinicians and ensure they are providing high-quality ultrasound services has not been studied. This project will examine the effectiveness and cost of two strategies for training non-radiologist clinicians to perform breast ultrasound in Rwandan district hospitals.

Integrating Telehealth to Advance Lung Cancer Screening

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are: 1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS? 2. Is the effectiveness of these telehealth strategies similar by race and sex? The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study

The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

Prospective Sample Collection Study for a Blood-Based cfDNA Methylation Assay for Ovarian Cancer Detection

The goal of this observational study is to learn whether a blood-based cell-free DNA (cfDNA) methylation assay can help detect ovarian cancer, especially early-stage ovarian cancer, in women undergoing clinical evaluation for ovarian tumors or gynecologic diseases. The main questions it aims to answer are: How well can this assay distinguish ovarian cancer from benign gynecologic diseases? How accurately can this assay detect early-stage ovarian cancer and other ovarian tumor subtypes? Researchers will compare the test results from participants with ovarian cancer and participants with benign gynecologic diseases to evaluate the diagnostic performance of the assay. Participants will: Provide blood samples for cfDNA methylation testing Allow researchers to collect clinical and pathological information related to their diagnosis Be grouped according to their final clinical or pathological diagnosis for analysis

PATHFINDER 2: A Multi-Cancer Early Detection Study

This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. The study will enroll approximately 35,000 and no more than 38,500 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 36 months at up to 40 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment.

Exploring the Potential of Artificial Intelligence for Earlier Breast Cancer Detection: A Retrospective Multi-Reader Study Based on AI-Assisted Mammographic Interpretation (EARLIEST-AI)

EARLIEST-AI Study type: Two-phase, multi-reader, blinded retrospective observational study based on data from a single clinic. The primary objective of the study is to assess the sensitivity and specificity of radiologists and Artificial Intelligence (AI) in interpreting mammographic examinations for breast cancer detection in a scenario where no previous examinations are available, and to compare the diagnostic performance of radiologists with and without AI support. The secondary objectives of the study are to assess the independent diagnostic performance of Computer Aided Detection (CAD) software, including sensitivity and specificity in identifying histopathologically confirmed breast cancer cases; to assess inter-reader and intra-reader variability in interpretation with and without AI support; to assess the agreement between AI outputs and histopathological findings; and to assess the impact of mammogram technical parameters on AI performance. Time frame: Review of a subset of mammograms randomly selected from those performed between January 1, 2012 and December 31, 2024. Imaging findings were classified according to the Breast Imaging Reporting and Data System (BI-RADS). Inclusion criteria: 1. Female patients aged 30 years or older. 2. One or more mammograms performed between January 1, 2012 and December 31, 2024. 3. Meets one of the following criteria: 3.1 Histopathologically confirmed diagnosis of breast cancer within 6 months of mammogram, 3.2 or two consecutive mammograms with BI-RADS 1 or BI-RADS 2. Exclusion criteria: 1. Mammograms of poor quality or artifacts that do not allow for reliable assessment. 2. History of breast surgery or previous breast cancer treatment that has significantly altered breast morphology. 3. Data deficiencies, including: 3.1. lack of previous histopathological data 3.2. or lack of available follow-up data.

Breast and Cervical Cancer Awareness Training in Visually Impaired Women

This quasi-experimental study aims to determine whether a breast and cervical cancer awareness training program can increase participation in cancer screening among women with visual impairments. The study also aims to identify barriers to screening and improve knowledge about cancer risk factors and screening methods. The main questions this study will address are: * Does the training increase the rate at which women with visual impairments attend cancer screening appointments? * Does the training improve participants' knowledge about breast and cervical cancer? Participants will: * Receive training on breast and cervical cancer risk factors and screening methods. * Learn how to apply to the Cancer Early Diagnosis, Screening, and Training Center. * Be encouraged to attend cancer screening during the study period. * Have knowledge and screening status assessed before the training, immediately after, and three months later.

Strategic Targeting for Optimal Prevention of Cancer

The primary goal of the study is to record data over the observation period to evaluate the clinical benefit of using hereditary cancer genomic diagnostics to assess overall hereditary genetic cancer risk profile and to help guide physicians to pursue preventative measures, which may lead to early detection and treatment of the condition.

Caris Biorepository Research Protocol

The Biorepository for Caris Life Sciences is designed for the purpose of making quality biospecimens and associated clinical data available for research studies related to advancing precision medicine and improving care for patients. The Caris Biorepository is a repository of prospectively collected biological specimens and associated clinical and demographic data gathered from multiple sources to be stored, used and shared for research. Caris Life Sciences will maintain the data and specimens and will control access to and use of the information and specimens by multiple individuals for multiple purposes which may evolve over time.

Cervical Cytology DNA Methylation for Endometrial Lesion Screening and Follow-up

The goal of this observational study is to evaluate the accuracy of a novel molecular test for screening and monitoring endometrial lesions in women at medium-to-high risk for endometrial cancer. The main questions it aims to answer are: * What is the sensitivity and specificity of the CISENDO test (a DNA methylation test on cervical cytology samples) for detecting histologically confirmed endometrial intraepithelial neoplasia (EIN) or invasive endometrial cancer? * How do DNA methylation levels change during the follow-up of endometrial lesions? Researchers will compare the results of the CISENDO test to the results from the standard diagnostic procedure (hysteroscopy with histology) to see if the molecular test can reliably identify high-risk lesions and track disease progression. Participants will: * Provide a residual liquid-based cervical cytology sample for the CISENDO test. * Undergo a standard diagnostic hysteroscopy examination (with or without biopsy) for comparison. * Some participants will return for follow-up visits at 6 and 12 months for repeat methylation testing and/or hysteroscopy to monitor their condition.