Metabolomics to Predict Treatment Response and Toxicities in Rectal Cancer

NCT06831669 | Recruiting

• 1 other identifier: CMRPG3P0091
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Colorectal cancer is the leading cause of cancer-related deaths in Taiwan, with rectal cancer accounting for approximately 27% of all cases. Total neoadjuvant therapy (TNT), which consists of chemotherapy and radiation therapy delivered before surgery, has become the standard of care for locally advanced rectal cancer. However, there is currently no reliable method for predicting the response to TNT or the occurrence of radiation proctitis, a common side effect of treatment. Objective: This study aims to evaluate the metabolomic profiles of individuals with locally advanced rectal cancer undergoing TNT and to identify a panel of metabolites that can predict treatment response and toxicities. Methods: A prospective cohort study will be conducted to enrol patients with locally advanced rectal cancer who are scheduled to receive TNT. Blood, urine, tissue, and faecal samples will be collected at baseline, during, and after chemoradiotherapy. Metabolomic profiling of the samples will be performed using liquid-chromatography mass spectrometry (LC-MS). Treatment response will be assessed based on clinical downstaging (defined as a decrease in tumour size and/or T and N stage after TNT) and pathological response, such as pathological complete response (pCR). Radiation proctitis will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. PCA and PLSDA will be used to identify metabolites that are associated with treatment response and radiation proctitis. Receiver operating characteristic (ROC) curves will be used to assess the predictive performance of the identified metabolites. Univariate and multivariate logistic regression will be used to build models to predict treatment response and radiation proctitis.

Conditions

Rectal Neoplasm Malignant

Keywords

Rectal cancer; Total neoadjuvant therapy; Metabolomics; Radiation proctitis

Outcome Measures

Primary Outcomes (1)

• Predictive Accuracy of Metabolomic Profiles for Complete Response (CR)

  Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of metabolomic signatures in predicting complete response (CR). For patients undergoing surgical resection, CR will be determined based on histopathological examination of resected specimens (pathological CR). For patients who do not undergo surgery, clinical CR will be defined by findings from digital rectal examination (DRE), colonoscopy, and imaging studies (e.g., MRI or CT) up to six months after radiotherapy completion.

  From enrollment to surgical resection or up to 6 months after completion of radiotherapy (whichever occurs first)

Secondary Outcomes (1)

• Number of Participants With Grade 3-4 Treatment-Related Toxicities as Assessed by CTCAE

  From initiation of radiotherapy to 21 days after completion.

Other Outcomes (2)

• Changes in Metabolomic Profiles From Baseline to Post-Radiotherapy

  At baseline, and within two weeks and three months following completion of radiotherapy.

• Correlation Between Changes in Metabolomic Biomarkers and Grade 3-4 Toxicities

  From baseline to 21 days after completion of radiotherapy.

Interventions

Collecting biospecimens OTHER

Collecting blood, urine, tissue, and faecal samples

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will prospectively recruit 250 patients with locally advanced rectal cancer who are scheduled to receive total neoadjuvant therapy (TNT) at Chang Gung Memorial Hospital, Linkou, over a two-year period from 2024 to 2025. Blood, urine, fecal, and tissue samples will be collected from patients at baseline, during, and after TNT.

You may qualify if:

• Histologically confirmed adenocarcinoma of the rectum
• Scheduled to receive total neoadjuvant therapy

You may not qualify if:

• Previous pelvic radiation therapy
• Inflammatory bowel disease

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Guishan, Taoyuan, 333, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, faecal, and tissue samples

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

Eric Yi-Liang Shen, PhD

CONTACT

0975366392; pts@cgmh.org.tw

Yu-Hsien Chou, MS

CONTACT

+886-935667922; yhc1228@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 18, 2025
• Study Start: January 5, 2024
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): December 12, 2033
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

TW (1)