Tokyo, Jan. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060376) titled 'A Prospective Cohort Study of Breast Partial Resection for Non-Invasive Ductal Carcinoma Under Polygon-Based High-Precision Margin Detection Without Radiation Therapy' on Jan. 26.

Study Type: Observational

Primary Sponsor: Institute - National Hospital Organization Nagoya Medical Center

Condition: Condition - Ductal carcinoma in situ Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - For patients undergoing partial mastectomy for ductal carcinoma in situ (DCIS), if the Polygon Margin Detection System,a high-precision margin detection system enabling microscopic examination of all shaved margins, yields negative results, a prospective cohort study will investigate whether the incidence of ipsilateral breast recurrence is non inferior to that observed in historical data on breast conserving surgery or in the cumulative incidence of contralateral breast cancer, thereby potentially eliminating the need for whole breast irradiation. or the cumulative incidence of contralateral breast cancer. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Female Key inclusion criteria - Patients must meet all of the following criteria Key exclusion criteria - Patients meeting any of the following criteria shall not be included in this study. (1) Patients with active concurrent or multiple cancers (synchronous or multiple cancers, and metachronous or multiple cancers with a disease free interval of 5 years or less. However, a history of the following pathologic stages of cancer that was completely resected shall not be included as active concurrent or multiple cancer, even if the disease free interval is less than 5 years). Gastric cancer "adenocarcinoma (general type)": Stage 0 I, Colon cancer (adenocarcinoma): Stage 0 I, Rectal cancer (adenocarcinoma): Stage 0 I, Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I, II, III, Renal cell carcinoma (clear cell carcinoma, clear cell carcinoma): Stage I Staging classification generally follows the UICC TNM 7th edition or equivalent cancer classification guidelines. (2) Patients confirmed to be BRCA positive. (3) Patients with metastasis to regional lymph nodes. (4) Patients deemed inappropriate for participation in this study by the principal investigator or co-investigator. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 26 Day Date of IRB - 2025 Year 12 Month 02 Day Anticipated trial start date - 2026 Year 01 Month 26 Day Last follow-up date - 2028 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068866

Disclaimer: Curated by HT Syndication.