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

NCT06746298 | Not Yet Recruiting DMC

• 1 other identifier: RNA-seq-Neo
• Study Type: observational
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rectal Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)

  From the start of the neoadjuvant therapy until just before surgery

Secondary Outcomes (3)

• Overall survival

  3 years

• Progression free survival

  3 years

• Total resection rate

  One month after surgery

Study Arms (1)

Rectal cancer patients receiving neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients intended for neoadjuvant therapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jing Sun

CONTACT

+86-13524284622; sj117788@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12