Clinical Research Directory

Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer

This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck. People with BHD are at increased risk of developing kidney cancer. Scientists have identified the chromosome (strand of genetic material in the cell nucleus) that contains the BHD gene and the region of the gene on the chromosome. This study will try to learn more about: * The characteristics and type of kidney tumors associated with BHD * The risk of kidney cancer in people with BHD * Whether more than one gene causes BHD * The genetic mutations (changes) responsible for BHD Individuals with known or suspected Birt Hogg-Dube syndrome, and their family members, may be eligible for this study. Candidates will be screened with a family history and review of medical records, including pathology reports for tumors, and films of computed tomography (CT) and magnetic resonance imaging (MRI) scans. Participants may undergo various tests and procedures, including the following: * Physical examination * Review of personal and family history with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor * Chest and other x-rays * Ultrasound (imaging study using sound waves) * MRI (imaging study using radiowaves and a magnetic field) * CT scans of the chest and abdomen (imaging studies using radiation) * Blood tests for blood chemistries and genetic testing * Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample for microscopic evaluation) * Cheek swab or mouthwash to collect cells for genetic analysis * Lung function studies * Medical photography of skin lesions These tests will be done on an outpatient basis in either one day or over 3 to 4 days. When the studies are complete, participants will receive counseling about the findings and recommendations. Individuals with kidney lesions may be asked to return periodically, such as every 3 to 36 months, based on their individual condition, to document the rate of progression of the lesions. ...

Benchmarking Large Language Models Against Tumour Boards for Oncology Treatment Recommendations

BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark comparing the treatment recommendations of six frontier large language models (LLMs) with those of multidisciplinary tumour boards (RCP) in oncology treatment planning. One hundred standardised synthetic cases (20 per localisation, across breast, lung, urological, digestive and gynaecological cancers) are submitted as identical structured input to two independent tumour boards per localisation and to six frontier LLMs. Every recommendation, human or model, is decomposed into five predefined decision domains (intent, surgery, radiotherapy, systemic therapy with its line, work-up and biomarkers). For each domain, concordance between two recommendations is scored 2 when the same options are selected, 1 when at least one option is shared, and 0 when none is shared; the score is computed automatically from the recommendation forms, without human scoring. The primary endpoint is the mean domain score between each LLM and each tumour board, read against the same score computed between the two tumour boards of the same case, so that humans and models are measured by an identical rule and no respondent contributes to its own reference. A co-primary safety endpoint captures the proportion of recommendations carrying serious harm potential, because concordance alone can conceal dangerous errors. Where the two boards select different options, the case-domain is classified EQUIPOISE and, like every discordance, is adjudicated by an independent panel blinded to the source of the recommendation. Tumour boards record their recommendations during the meeting itself, on a dedicated platform (https://etude-beacon.fr) that reveals a case only once it is presented and time-stamps that reveal, so that no board can read a case in advance. BEACON is designed as reusable, openly licensed, pre-registered infrastructure: all synthetic cases, evaluation rubrics, scoring algorithms, verbatim prompts and raw model outputs are released for full reproducibility.

HTL0039732 in Participants With Advanced Solid Tumours

The purpose of this trial is to evaluate a new drug, HTL0039732, that will be administered on its own (as a monotherapy) and in combination with atezolizumab or with other approved anti-cancer therapies, in participants with advanced solid tumours.

Robotic vs Laparoscopic and Open Surgery for Abdominopelvic Cancers

Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Results may differ across cancer types, and factors such as how complex the surgery is and how experienced the surgeon is may also influence the outcome. This retrospective cohort study examined adults who underwent curative-intent surgery for one of seven abdominopelvic cancers (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at a large tertiary hospital in Seoul, South Korea, between January 2012 and December 2021. Patients were classified into three groups according to the surgical approach they received: open, laparoscopic, or robotic surgery. The main outcome was 1-year disease-free survival, defined as the time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. Additional outcomes included 1-year mortality, overall mortality during follow-up, major postoperative complications, acute kidney injury, and length of hospital stay. To reduce differences between groups that might affect the comparison, the study used a statistical method called propensity score overlap weighting. Additional analyses adjusted for surgical complexity, surgeon experience including robotic learning curve, and pathological cancer stage to isolate the effect of the surgical platform itself. The purpose of this study was to evaluate whether the association between surgical approach and early oncologic and perioperative outcomes differed across the seven cancer types, and whether any observed advantage of the robotic platform remained after accounting for these factors.

A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment

Many clinical trials evaluating cancer treatments require patients to undergo testing for specific molecular markers as part of eligibility screening, typically using immunohistochemistry or sequencing. Because relatively few patients may carry a required marker, trial investigators often test large numbers of patients to identify the few who may ultimately qualify for enrollment. Pathology laboratories routinely produce hematoxylin-and-eosin (H\&E) slides during cancer diagnosis. Pathology foundation models-large neural networks pretrained on millions of histology images-have shown promise in predicting molecular characteristics from these slides. Researchers can use these models to build classifiers that predict specific molecular markers and prioritize patients for confirmatory testing. This study evaluates FATHOM (Facilitating Accrual through Tumor Histology and Omics Matching), an autonomous research system powered by large multimodal models. Its agents read registered clinical trial records, identify molecular markers used as enrollment criteria, build prediction models using pathology foundation models, select the individual models or model combinations that best meet prespecified criteria, set their decision thresholds, and determine whether to deploy them. Together, a prediction model, its decision threshold, and the decision to deploy it constitute an AI prediction policy. Before FATHOM runs, the investigators preregister the clinical trial records that its agents may read, the cutoff date that defines which trial information they may use, the rules governing the agents, and the analysis plan. The system timestamps and locks each policy immediately after an agent produces it. The investigators then apply the policies to archived patient slides and compare their predictions with existing molecular marker results. The primary outcome is the proportion of prespecified evaluation scenarios in which an agent-generated policy, compared with universal molecular testing, either enriches the population selected for confirmatory testing with marker-positive patients or safely spares patients from confirmatory testing while meeting prespecified performance criteria. This study analyzes existing pathology images and clinical trial records only. It does not enroll or contact patients, influence patient care, or affect participation in any clinical trial.

The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Savolitinib vs. Sunitinib in MET-driven PRCC.

This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

Multimodal Prediction of Postoperative Prognosis After Partial Nephrectomy for Endophytic Renal Cell Carcinoma

This retrospective observational cohort study aims to develop and externally validate an imaging-clinical multimodal fusion model for predicting postoperative prognosis in patients with endophytic renal cell carcinoma undergoing partial nephrectomy. Preoperative computed tomography imaging features, three-dimensional reconstruction-derived tumor characteristics, radiomics features, and clinical variables will be integrated using machine learning and deep learning approaches. The primary objective is to evaluate whether the multimodal model improves prediction of postoperative prognostic outcomes compared with single-modality models based on clinical or imaging features alone.

Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region. The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process. The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.

MRI Functional Imaging Characteristics and Fat Quantification of CT-fat-free Renal Neoplasms: Relationships With Histological Classifications and Molecular Markers

The knowledge of the histological diagnosis and its subtype of a renal parenchymal tumor is important for determine whether the choice of a specific regimen of chemotherapy, target therapy and immunotherapy could be suitable and effective for treating this tumor. Computed tomography (CT) has been considered as an excellent imaging modality for detecting intra-tumoral fat, and most of renal angiomyolipomas (AML) could be thus confidently diagnosed on computed tomography by showing intra-tumoral fat. However, if a renal parenchymal tumor has no detectable fat in the tumor on computed tomography, there is a long list of its diagnosis including benign neoplasms as angiomyolipoma with minimal fat, oncocytoma, metanephric adenoma, etc., epitheloid angiomyolipoma (eAML) malignant potential, malignant neoplasms as renal cell carcinoma (RCC), sarcoma, malignant eAML, etc. Furthermore, there are three kinds of anticancer drug (antiangiogenetic drug, mammalian target of rapamycin inhibitors, immune modulators, and whether the anticancer drug is effective mainly depending on subtypes of RCCs. Nonetheless, computed tomography could not reliably differentiate histological types of renal parenchymal masses except renal AMLs with abundant fat. Therefore, for patients without established diagnoses by imaging examinations, further biopsy of the renal tumor is usually mandatory to validate the histological diagnosis and subtype. Thus, this study plans to enroll 60 patients with renal parenchymal masses which show no intra-tumoral fat on computed tomography. All enrolled patients will undergo multiparametric and fat-detection magnetic resonance imaging (MRI).

CD70-targeted immunoPET Imaging of Kidney Cancer

The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)

To conduct prospective studies to confirm the value of circulating tumor DNA and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.

Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma

This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.

Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions

Pheochromocytomas and paragangliomas are neural crest-derived tumors of the nervous system that are often inherited and genetically heterogeneous. Genetic screening is recommended for patients and their relatives, and can guide clinical decisions. However, a mutation is not found in all cases. The aims of this proposal are to: 1) to map gene(s) involved in pheochromocytoma, and 2) identify genotype-phenotype correlations in patients with pheochromocytoma/paraganglioma of various genetic origins.

Planning Operative Strategy Using a Digital Renal Artery Clamping Tool

A proposed new tool ('DIPLANN-tool' - Digital Planning in Nephrectomy) for predicting kidney perfusion zones on a segmented 3D model during robot-assisted partial nephrectomy (RAPN) for localized renal cancer demonstrated high accuracy when planning selective clamping (SC) for RAPN. However, the tool's clinical added value still needs to be confirmed. Therefore, a randomized controlled trial using a study and control group is the preferred study design. Experimental group: the use of the DIPLANN-tool + conventional computed tomography (CT) imaging for preoperative planning and perioperative guidance during RAPN. Control group: the use of only conventional CT imaging for preoperative planning and perioperative guidance during RAPN (= current standard of care). The primary endpoint is planning and performing as planned a SC strategy. Secondary endpoints include patients' health, patients' insight and surgeons' benefits.

Zero Ischemia Robot-Assisted MWA Assisted Suture-less Tumor Enucleation of RCC With T1 Stage

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.

Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.