Tokyo, Nov. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059900) titled 'Microsatellite Instability (MSI) Screening Study for Resectable Solid Tumors (Excluding Colorectal Cancer)' on Nov. 27.
Study Type:
Observational
Primary Sponsor:
Institute - National Cancer Center Hospital East
Condition:
Condition - Malignant solid tumors
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To clarify the frequency of high-frequency microsatellite instability (MSI-H) in resectable solid tumors (excluding colorectal cancer) and the patient background according to MSI status.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1)Untreated malignant tumors confirmed by histopathological diagnosis
2)Age 18 years or older
3)Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
4)Cannot be expected to achieve cure with local therapy using endoscopy, cystoscopy, etc.
5)Is a locally advanced solid cancer (excluding colorectal cancer) expected to achieve cure with surgical resection, radiation therapy, or chemoradiation therapy
6)Tumor tissue specimens can be submitted to this study
Key exclusion criteria - 1)Presence of distant metastatic lesions
2)Clinical diagnosis of carcinoma in situ or mucosal carcinoma
3)Diagnosis of active concomitant cancer
*Lesions corresponding to carcinoma in situ or mucosal carcinoma deemed curable by local therapy are not included in active concomitant cancer
4)Severe concomitant diseases (e.g., poorly controlled diabetes, infections, symptomatic interstitial pneumonia, pulmonary fibrosis, etc.)
5)Lack of willingness to participate in the study
6)If the attending physician determines the patient is not suitable for enrollment in this study
Target Size - 5000
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 05 Month 08 Day
Date of IRB - 2025 Year 07 Month 10 Day
Anticipated trial start date - 2025 Year 07 Month 24 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068392
Disclaimer: Curated by HT Syndication.