Using biopsies to improve diagnosis of rectal cancer after treatment

Study on the Value of Multi-points and Full-thickness Biopsy in the Diagnosis of Clinical Complete remiSsion After Neoadjuvant Therapy for Rectal Cancer

This study is testing if using special biopsy techniques can help doctors more accurately determine if rectal cancer patients have fully responded to treatment before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04743102 on ClinicalTrials.gov

What this trial studies

This study aims to enhance the accuracy of diagnosing clinical complete response (cCR) in rectal cancer patients following neoadjuvant therapy. It proposes the use of multi-points and full-thickness biopsy techniques in conjunction with traditional assessment methods such as digital examination, serum CEA levels, MRI, and endoscopy. The goal is to better identify patients who have achieved pathological complete response (pCR) before undergoing radical surgery, addressing the current variability in cCR and pCR concordance rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed colorectal adenocarcinoma who have undergone neoadjuvant therapy and show no detectable tumor.

Not a fit: Patients with advanced metastatic disease or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and potentially reduce unnecessary surgeries for rectal cancer patients.

How similar studies have performed: While there is variability in existing studies regarding cCR and pCR, this specific approach using multi-points and full-thickness biopsies is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Previous history of malignant colorectal tumor;
* Patients complicated with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients requiring emergency surgery;
* Unresectable lymph node metastasis;
* Recently diagnosed with other malignant tumors;
* Patients who had participated in or were participating in other clinical trials within 4 weeks prior to enrollment;
* ASA rating ≥IV and/or ECOG physical status score ≥2 points;
* 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;
* Patients with other clinical or laboratory conditions considered by the investigator should not participate in the study

Where this trial is running

Beijing, Beijing Municipality

• Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiagang Han

Conditions Rectal Cancer; Neoadjuvant Therapy; Complete Remission; Metastasis; rectal cancer; neoadjuvant therapy; clinical complete remission; full-thickness biopsy