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.

TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography

TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD). Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice.

Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study

Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis. Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.