NCT04743102Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 4 Feb 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04743102
What you commit to
- Study type: Interventional
- Planned participants: 260
- From 1 Jan 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
Other illness
- Previous history of malignant colorectal tumor;
- Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
- Recently diagnosed with other malignant tumors;
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases cannot tolerate surgery;
- a history of serious mental illness;
- \- pregnant or lactating women;
- Those with uncontrolled infection;
Lab values
- Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study
Other
- Unresectable lymph node metastasis;
- ASA rating ≥IV and/or ECOG physical status score ≥2 points;
Who the study is looking for
- Adult male and female, between 18 and 80 years old;
- Colonoscopy biopsy pathology confirmed colorectal adenocarcinoma;
- The distance from the lower margin of the tumor to the anal margin ≤12 cm (endoscope) or to the anorectal ring ≤8 cm;
- The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
- Initial local MRI stage was T2 or T3A or T3B, N0-2, negative for extramural vascular invasion (EMVI), circumferential ential resection margin (CRM), and no peripheral iliac, common iliac, obturator, or abdominal aortic lymph node metastasis;
- CCR patients evaluated after neoadjuvant therapy (no mass or ulcer found on digital rectal examination;Endoscopic examination showed no other changes except flat scar, telangiectasia or pallor of mucosa.MRI or rectal ultrasound showed no residual tumor in the primary site and lymphatic drainage area.Serum carcinoembryonic antigen (CEA) was normal.
- Signing informed consent for surgery.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing ChaoYang Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.