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

NCT04743102 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-02-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    lead OTHER

Principal Investigators

  • Zhenjun Wang · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04743102 on ClinicalTrials.gov