Trials / Recruiting

RecruitingNCT03573791

Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer

Identification of Tissue Biomarkers for Predicting Neoadjuvant Chemoradio-resistance in Patients With Middle-low Local Advanced Rectal Cancer.

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 152 (estimated)

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

Detailed description

According to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypT0N0) and poor response (\>ypT1-2N0). Differentially expressed genes between complete response and poor response will be analyzed. A scoring formula will be established based on the results. Tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via RNA sequencing.

Conditions

Timeline

Start date: 2018-05-21
Primary completion: 2026-05-21
Completion: 2027-05-21
First posted: 2018-06-29
Last updated: 2025-03-30

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT03573791. Inclusion in this directory is not an endorsement.