RecruitingNot ApplicableNCT04743102

Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

Sponsor

Beijing Chao Yang Hospital

Enrollment

260 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Metastasis Rectal Cancer Complete Remission

Summary

Background There is currently no reliable means to restage rectal cancers after neoadjuvant chemoradiation. There are still no reliable methods to identify patients with pCR before radical surgery. As a result, clinical complete response (cCR), defined as no clinical detectable tumor by physical examination, endoscopic evaluation, and imaging, is designed as a surrogate endpoint for pCR. However, the concordance between cCR and pCR varies from 22% to 96% in different reports, which questions the clinical value of such strategies. Therefore, based on rectal diginal examination, serum CEA, MRI, endoscopy examination, we suggested to add multi-points and full-thickness biopsy technique to further improve the accuracy of cCR.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a more thorough biopsy technique (multiple sites, full-thickness sampling) can more accurately confirm that rectal cancer has completely disappeared after chemotherapy and radiation, potentially allowing patients to avoid surgery. **You may be eligible if...** - You are between 18 and 80 years old - You have colorectal adenocarcinoma (confirmed by biopsy) - Your tumor is in the lower rectum (within 12 cm of the anus) - Your cancer was at a stage appropriate for pre-surgery chemoradiation - Your heart, lungs, liver, kidneys, and bone marrow are healthy enough for surgery **You may NOT be eligible if...** - Your tumor is higher up in the colon (above 12 cm from the anus) - Your cancer was already very advanced (T4 or with certain high-risk features) before treatment - You have serious organ problems that prevent surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREmulti-points and full-thickness Biopsy

Four points around the tumor site and center of the tumor site full-thickness Biopsy

DIAGNOSTIC_TESTtraditional cCR

diginal examination, endoscopy test, rectal MRI, and serum CEA level

Locations(1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

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NCT04743102

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