Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061703) titled 'A Multicenter Prospective Observational Study on Surveillance After Non-Curative Endoscopic Resection for Esophageal Cancer' on June 1.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka International Cancer institute
Condition:
Condition - superficial esophageal cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the outcomes of surveillance without additional treatment after non-curative endoscopic resection for esophageal cancer
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
= 20 years at registration.
Patients must agree to undergo either of the following surveillance strategies:
a. Recommended surveillance
0-3 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 4 (3-5) months, and EGD (+EUS) at least once yearly
3-5 years after ER: contrast-enhanced CT of the neck, chest, and abdomen every 6 (4-8) months, and EGD (+EUS) at least once yearly
Non-contrast CT is permitted in patients unable to receive contrast agents because of renal dysfunction, contrast allergy, or other reasons.
b. Outpatient follow-up at least once yearly with CT examinations as clinically indicated.
Written informed consent for study participation has been obtained from the patient.
Key exclusion criteria - Presence of a prior or synchronous double cancer within the past 3 years; however, this does not include cancers with an estimated 5-year relative survival rate of >=95%.
Presence of psychiatric disorders or psychiatric symptoms that significantly interfere with activities of daily living and are judged to make study participation difficult.
Judged by the principal investigator or sub-investigator to be inappropriate for inclusion in the study.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 12 Day
Date of IRB - 2026 Year 05 Month 12 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2033 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070605
Disclaimer: Curated by HT Syndication.