RecruitingNCT07393048

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


Sponsor

Beijing Friendship Hospital

Enrollment

60 participants

Start Date

Feb 15, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood test that detects circulating tumor DNA (ctDNA) — tiny fragments of cancer DNA released into the bloodstream — can accurately predict how well neoadjuvant (pre-surgery) treatment is working in people with rectal cancer. The test could help doctors adjust treatment plans before surgery. This is an observational study — it does not change your treatment. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with rectal adenocarcinoma (rectal cancer) confirmed by biopsy - Your cancer is clinical stage II or III on MRI - Your tumor is in the lower rectum (within 10cm of the anal opening) - Your cancer can be surgically removed - You have not yet received any cancer treatment (no prior chemo, radiation, or surgery for this cancer) **You may NOT be eligible if...** - You have already received treatment for rectal cancer - Your cancer is not surgically removable - You have serious organ problems that prevent standard treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPersonalized ctDNA-MRD Detection

This observational study involves collecting clinical data and biospecimens (peripheral blood and tissue samples) from participants at multiple timepoints. Personalized ctDNA-MRD detection technology, together with copy number variation and mtDNA profiling, is applied to analyze the samples. The primary goal is to predict neoadjuvant therapy efficacy by identifying biomarkers associated with key outcomes, such as tumor regression grade and pathological complete response rate. No experimental drugs or treatments are administered.


Locations(1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

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NCT07393048


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