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

Study acronym: BIOPSY
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 21, 2023 (before its estimated December 31, 2023 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv2
  2. Study First Submitted
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.
Trial Details
NCT Number NCT04743102
Lead Sponsor Beijing Chao Yang Hospital
Conditions
(from sponsor)		 Rectal Cancer, Neoadjuvant Therapy, Complete Remission, Metastasis
Related terms Neoplasm Metastasis, Pathologic Complete Response, Rectal Neoplasms
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov