Tokyo, March 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060793) titled 'Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors' on March 2.
Study Type:
Observational
Primary Sponsor:
Institute - National Cancer Center Hospital East
Condition:
Condition - Clinical stage I-IV resectable solid tumors planned to be treated with definitive therapy
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to identify biomarkers reflecting the molecular biological nature of resectable solid tumors by performing comprehensive molecular profiling of blood and tumor tissue specimens from patients undergoing curative-intent treatment, and integrating these data with clinical information.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet all eligibility criteria and none of the exclusion criteria will be enrolled in this study.
1)18 years-old <=
2)Diagnosed with a resectable solid tumor of clinical stage I-IV.
3)Planned to undergo curative-intent treatment, including curative surgical resection or definitive chemotherapy/chemoradiotherapy.*1
4)Availability of tumor tissue specimens for pathological evaluation.*2
5)ECOG Performance Status (PS) of 0 or 1.
6)Written informed consent.
*1 Patients scheduled for curative resection are eligible even if they undergo preoperative chemoradiotherapy.
*2 A tissue biopsy prior to treatment initiation is preferred; however, surgical specimens are acceptable in cases undergoing surgery.
Key exclusion criteria - 1)Active multiple primary cancers
2)Pregnant
3)History of other malignancies within 3 years prior to enrollment
4)Severe comorbid diseases (e.g., poorly controlled diabetes, infections, symptomatic interstitial pneumonia or pulmonary fibrosis)
5)Other reasons deemed inappropriate for this study by the principal investigator.
Target Size - 4000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 19 Day
Date of IRB - 2026 Year 02 Month 24 Day
Anticipated trial start date - 2026 Year 04 Month 01 Day
Last follow-up date - 2034 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068986
Disclaimer: Curated by HT Syndication.