Clinical Research Directory

Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors

As survival rates following breast cancer surgery continue to improve, long-term survivorship management has emerged as a crucial clinical priority. In particular, two major clinical challenges remain: (1) maintaining medication adherence to 5 to 10 years of adjuvant endocrine therapy (tamoxifen or aromatase inhibitors) by actively managing treatment-related adverse symptoms, and (2) early detection and prevention of chronic breast cancer-related lymphedema following axillary lymph node dissection (ALND). Conventional passive monitoring relying on routine outpatient visits every 3 to 6 months often fails to detect daily symptom worsening or subclinical fluid accumulation in a timely manner. This single-center, prospective, open-label, parallel-group randomized clinical trial evaluates the efficacy of an Agentic AI-based digital healthcare application (Pinkmate; a non-medical mobile health app) and a home bioelectrical impedance analyzer (InBody BWA ON) across two independent cohorts under a single master protocol. This study is conducted at Seoul St. Mary's Hospital and supported by the National IT Industry Promotion Agency (NIPA; Grant No. PJT-25-050007). Dual enrollment is permitted for patients meeting eligibility criteria for both cohorts (total target enrollment: 264 participants). 1. Cohort 1: Medication Adherence and Active Symptom Management (N=200) Two hundred breast cancer patients initiating or receiving adjuvant endocrine therapy are randomized 1:1. The experimental arm receives weekly electronic patient-reported outcomes (ePRO), conversational AI chatbot-triggered symptom questionnaires, clinician dashboard alert flags, and proactive telephone calls from clinical staff within 48 hours of an alert. The control arm uses basic medication reminders/checklists and quarterly ePRO collection without proactive alerts. The primary endpoint is the Proportion of Days Covered (PDC) at 6 months. 2. Cohort 2: Early Lymphedema Monitoring and Management (N=64) Sixty-four breast cancer patients who underwent ALND (including newly operated patients and prior ALND patients without clinical lymphedema) are randomized 1:1. The experimental arm uses a loaned home InBody BWA ON device at least twice weekly linked to the Pinkmate app; persistent dashboard alerts (3 consecutive days) trigger proactive phone counseling and early clinic visit recommendations. The control arm undergoes routine outpatient surveillance using the in-clinic InBody 770 analyzer and tape measurements, along with educational self-care app content. In both arms, standardized rehabilitation therapy is initiated based on in-clinic InBody 770 and tape circumference measurements using identical criteria. The primary endpoints are the percentage change in affected upper limb volume and the change in affected-arm ECW/TBW ratio from baseline to 6 months post-enrollment.

Ruxolitinib for Premalignant Breast Disease

This study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.

HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery

This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS). After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing. Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.

Breast Tumour Size Measurement by Field Cycling Imaging

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can accurately estimate tumour size in patients with a type of breast cancer called ductal carcinoma in situ (DCIS). The main question it aims to answer is: Can FCI accurately estimate DCIS lesion size compared with histology results? Participants will have a standard MRI scan and an FCI scan before undergoing surgery to remove the tumour.

EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.

Hong Kong Breast Cancer Study

Introduction: With population ageing and increasing Westernization breast cancer continues to be important health conditions among women in Hong Kong. Greater collaborative research efforts are needed to examine the questions about population screening for breast cancer, the aetiology of such lesions and outcomes of breast cancer during survivorship period. There is a lack of locally-relevant models for assessing breast cancer risk. Contribution of novel genetic factors to breast cancer, identification of the key and functional alleles in gene regions associated with risk of breast cancer as well as gene-environment interaction, requires further investigation in Chinese population. Prognostic research studies in the West may not be readily applicable to the Chinese population. Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local Chinese by using case-control and cohort study design in the health care setting in Hong Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and to build infrastructure and biobank for breast cancer surveillance. We will follow up cases prospectively as a survivor cohort. Methods: A hospital-based case-control study and a prospective survivor cohort study will be conducted. Consecutive incident breast cancer and DCIS cases (n=3,501) within a 36-month period in Hong Kong were recruited from public hospitals, private hospitals and private practices; and controls were selected by frequency-matching on factors such as age and hospital/clinic setting, whenever possible. Cases will be prospectively followed up over a 10-year period, and data collection will occur at baseline (within 24 weeks of diagnosis), 3, 5 and 10 years following baseline assessment. Biologic samples (including both blood, and tumour and normal breast tissue samples from the cases, and blood samples from the controls) will be collected for later genetic and molecular study including WGS, GWAS, gene-environment interaction and molecular functional studies. Depending on availability of pathology samples and resources, additional studies such as tissue microarray block production will be considered and performed in future. Data will be analysed by traditional regression, EWAS and genetic association methods, whenever relevant. Public Health Implications: The repository of clinical, radiological and biological materials assembled through this case-control study will serve as a common, publicly accessible platform for subsequent functional analysis and scientific interrogation. The case-control findings would offer an improved understanding to the state of the science on aetiology of breast cancer in Chinese women. In the genomics analysis, potential refined classification of breast tumours may enhance our understanding, detection and follow-up of such lesions, as well as enable us to have more informed targeted and personalized treatment selection for our women population. The cohort study findings are important for developing an effective strategy for the improvement of overall survival and quality of life for the cancer survivors in Chinese population.