Tokyo, June 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061815) titled 'Significance Evaluation of Early-stage Disease via Circulating Tumor Cell' on June 6.

Study Type: Observational

Primary Sponsor: Institute - Tochigi Cancer Center

Condition: Condition - Colorectal Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the significance of circulating tumor cell testing in early-stage colorectal cancer. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Histologically diagnosed as tubular adenocarcinoma, either well-differentiated or moderately differentiated, by endoscopic biopsy of the primary colorectal cancer lesion. 2. The main tumor location is one of the following: cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, upper rectum, or lower rectum. 3. Diagnosed as cStage I disease, with a depth of invasion of cT1 to 2, based on comprehensive assessment including chest, abdominal, and pelvic CT with a slice thickness of 5 mm or less, and/or pelvic MRI. 4. No lymph node metastasis is detected. 5. No distant metastasis is detected. 6. No synchronous multiple cancers are detected based on comprehensive assessment using lower gastrointestinal endoscopy and imaging studies, including barium enema examination, abdominal/pelvic CT, or CT colonography. However, cTis or cT1a lesions, which are expected to be curatively resectable by endoscopic resection and in which the cancer is expected to remain within the submucosal layer with an invasion depth of less than 1,000 um, are not regarded as multiple cancers. 7. Age at registration is 20 years or older. 8. Performance status is 0 to 2 according to the ECOG criteria. 9. The patient is able to tolerate oral intake. 10. The patient has no history of rectal resection, excluding endoscopic resection, or pelvic radiotherapy, including treatment for other types of cancer. 11. For patients registered at Tochigi Cancer Center, enrollment is limited to cases in which consent to participate in the Tochigi Cancer Biobank has been obtained. Key exclusion criteria - 1. The patient has active synchronous or metachronous multiple cancers. 2. The patient has lymph node metastasis. 3. The patient has distant metastasis. 4. Patients undergoing additional surgical resection after endoscopic treatment are excluded. 5. The patient has an infection requiring systemic treatment. 6. The patient is undergoing hemodialysis or has renal dysfunction, defined as a serum creatinine level exceeding the normal range at each participating institution. 7. The patient is receiving continuous systemic administration, either oral or intravenous, of corticosteroids or other immunosuppressive agents. 8. The patient has poorly controlled diabetes mellitus. 9. The patient is positive for HIV antibodies. 10. The patient has interstitial pneumonia, pulmonary fibrosis, or both, as diagnosed by chest CT. Target Size - 10

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 09 Month 11 Day Date of IRB - 2025 Year 09 Month 12 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2032 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070736

Disclaimer: Curated by HT Syndication.