NCT04743102

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Neoadjuvant Therapy
• Complete Remission
• Metastasis

Interventions

Type	Name	Description
PROCEDURE	multi-points and full-thickness Biopsy	Four points around the tumor site and center of the tumor site full-thickness Biopsy
DIAGNOSTIC_TEST	traditional cCR	diginal examination, endoscopy test, rectal MRI, and serum CEA level

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2028-12-31
• First posted: 2021-02-08
• Last updated: 2023-02-21

Locations

1 site across 1 country: China