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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; Neoadjuvant Therapy

• Study Type: Observational
• Enrollment (Estimated): 118

Contacts and Locations

• Study Contact: Name: Jing Sun; Phone Number: +86-13524284622; Email: sj117788@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Rectal cancer patients intended for neoadjuvant therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rectal cancer patients receiving neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Minimally Invasive Surgery Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: RNA-seq-Neo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No