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Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Sponsor: Beijing Chao Yang Hospital
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.
Official title: Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2021-01-01
Completion Date
2028-12-31
Last Updated
2023-02-21
Healthy Volunteers
No
Interventions
multi-points and full-thickness Biopsy
Four points around the tumor site and center of the tumor site full-thickness Biopsy
traditional cCR
diginal examination, endoscopy test, rectal MRI, and serum CEA level
Locations (1)
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, China