Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
Location status: Recruiting
NCT Number: NCT04743102
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100020, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Four points around the tumor site and center of the tumor site full-thickness Biopsy
diginal examination, endoscopy test, rectal MRI, and serum CEA level
Time frame: 8-12 weeks after preoperative chemoradiotherapy for locally advanced rectal cancer
Clinical complete response rate between two groups after examinations following preoperative chemoradiotherapy for rectal cancer
Time frame: 2 weeks after patients received radical operation
No tumor cell found in surgical specimens
Time frame: 5 years after operation or "watch and wait" approach
no tumor regrowth or recurrence or metastasis found
Time frame: 5 years after operation or "watch and wait" approach
survive during following
Contact information is provided by the study sponsor or research team.
Jiagang Han
CONTACT
Zhiwei Zhai
CONTACT
Beijing Chao Yang Hospital
Other
Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer
Acronym: BIOPSY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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