A Prospective Study of Expression Profiling-based Assessment of the Efficacy of Neoadjuvant Therapy for Rectal Cancer

Not yet recruiting

• Conditions: Rectal Cancer; Neoadjuvant Therapy

• Registration Number: NCT06746298
• Lead Sponsor: Shanghai Minimally Invasive Surgery Center

Brief Summary

This is a prospective study of expression profiling-based assessment of the efficacy of neoadjuvant therapy for rectal cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-01-01
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Age ≥18 years, male or infertile female
• Patients with rectal adenocarcinoma diagnosed by colonoscopic biopsy
• Neoadjuvant therapy according to guideline recommendations
• Endoscopic biopsy with access to biopsy tissue for subsequent RNA-seq testing
• Patients who do not have a combination of primary malignant tumors elsewhere.
• Patients who understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria

• Samples are not collected, stored, or processed in accordance with specified requirements
• Sample does not meet the requirements for subsequent RNA-seq testing
• Cases enrolled with a subsequent diagnosis other than rectal adenocarcinoma.
• The patient refuses or is unable to complete the entire neoadjuvant treatment
• Lack of post-neoadjuvant imaging results and lack of routine postoperative pathology results.
• Other patients who, in the judgment of the investigator, do not meet the enrollment requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	From the start of the neoadjuvant therapy until just before surgery	The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	The time from the start of treatment to death due to any cause.
Progression free survival	3 years	The period from the date of beginning treatment until the date of disease progression or death from any cause
Total resection rate	One month after surgery	Surgically removed tissue without residual cancer cells