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Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Observational

SUMMARY

This study is a single-center, prospective, observational clinical trial enrolling patients with locally advanced rectal cancer (cT3-4aN0M0 and cT1-4aN1-2M0). By collecting tissue and blood samples at multiple timepoints, and integrating multi-omics data including ctDNA mutations, copy number variations, and mtDNA profiles, a multi-omics model will be constructed to predict the efficacy of neoadjuvant therapy for rectal cancer.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

View:

• 1: Signed a written informed consent form and voluntarily participated in this study

• 2: Aged 18-75 years, regardless of sex

• 3: Histopathologically confirmed rectal adenocarcinoma

• 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition)

• 5: Distance from the lower tumor margin to the anal verge ≤10 cm

• 6: Surgically resectable

• 7: Able to swallow tablets normally

• 8: ECOG PS 0-1

• 9: No prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery

• 10: Scheduled to undergo surgical treatment after completion of neoadjuvant therapy

• 11: No surgical contraindications

• 12: Normal function of major organs, including: complete blood count, blood biochemistry, and coagulation function

Locations

Other Locations

China

Beijing Friendship Hospital

RECRUITING

Beijing

Contact Information

Primary

Yao Hongwei Professor, Doctoral Degree

yaohongwei@ccmu.edu.cn

13611015609

Time Frame

Start Date: 2026-02-15

Estimated Completion Date: 2028-12-31

Participants

Target number of participants: 60

Treatments

Rectal Cancer ctDNA-MRD Detection Cohort

This study is an exploratory study, with an expected enrollment of 60 patients diagnosed with stage II-III rectal cancer who are scheduled to undergo neoadjuvant therapy. The sample collection and testing procedures are as follows: Before neoadjuvant therapy: Baseline endoscopic biopsy tissue or paraffin sections:1.1 Two pieces of endoscopic biopsy tissue, approximately 2 mm in diameter, are collected and placed in tissue preservation tubes.1.2 Ten unstained tissue slides are prepared. Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the following assays:① ctDNA-customized MRD high-depth sequencing;② ctDNA shallow whole-genome sequencing (sWGS) for monitoring copy number variation (CNV) profiles;③ Mitochondrial DNA (mtDNA) analysis. During neoadjuvant therapy (within 2 weeks after radiotherapy completion): Peripheral blood collection: 10 mL of blood is collected using cell-free DNA blood collection tubes for the followin

Related Therapeutic Areas

Colorectal Cancer

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