Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061676) titled 'Validation of the Clinical Utility of the CSGSA-AI Diagnostic Model for Early Cancer Screening' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Keio University, School of Medicine

Condition: Condition - Colorectal cancer, stomach cancer, lung cancer, pancreatic cancer, ovarian cancer, endometrial cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify the effectiveness of the CSGSA a new early detection screening test using tumor markers and serum glycoproteins, which are obtained from blood and to further improve its accuracy. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - [Control Group (Healthy Individuals)] Individuals undergoing routine health checkups or comprehensive medical screening at the Keio University Center for Preventive Medicine. Individuals with no prior history of cancer and no current subjective symptoms, whom a physician has determined (e.g., via medical interview) to have an extremely low likelihood of having cancer. Individuals aged 20 to 75 years at the time of informed consent (regardless of gender). Individuals who have provided voluntary informed consent to participate in this study, documented via electronic records or similar means. [Case Group (Cancer Patients)] Individuals with a presumptive diagnosis of primary colorectal, gastric, lung, pancreatic, ovarian, or endometrial cancer, based on standard diagnostic methods (e.g., a combination of endoscopy/imaging and histopathology). Note: If a definitive diagnosis has not been established prior to the test or surgery (at the time of blood collection), blood samples will be collected from all patients with suspected cancer. Once a definitive diagnosis is confirmed (e.g., via postoperative histopathology), malignant cases will be assigned to the Case Group, while benign cases will be classified into the Control Group. Patients who have not yet initiated any treatment (e.g., surgery, chemotherapy, radiation therapy, or hormone therapy) for the diagnosed cancer (i.e., treatment naive patients). Individuals aged 20 to 75 years at the time of informed consent (restricted to females for ovarian cancer; regardless of gender for other cancer types). Patients who have provided voluntary informed consent to participate in this study, documented via electronic records or similar means. Key exclusion criteria - Individuals meeting any of the following criteria will be excluded from this study: Individuals with severe renal, hepatic, respiratory, or cardiac dysfunction. Individuals with an active infection. Individuals who have already initiated treatment. Any other individuals deemed ineligible for participation by the principal investigator or co-investigators. Target Size - 760

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070566

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