Metabolomics to Predict Treatment Response and Toxicities in Rectal Cancer
NCT ID: NCT06831669
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
250 participants
OBSERVATIONAL
2024-01-05
2033-12-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radical vs Local Excision for Rectal Cancer With Clinically Complete Remission
NCT05964530
Impact of Environmental Factors and Metabolomics on Colorectal Cancer.
NCT06643429
Molecular Study and Precision Medicine for Colorectal Cancer
NCT05883683
Translational Research in Identifying Molecular Mechanisms for Rectal Cancer Metastasis
NCT02979795
Investigation of Methylation of EGFR in the Response of the Cetuximab in Metastatic Colorectal Cancer Patients
NCT02022995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Rationale of the project: Metabolomics is a powerful tool for identifying biomarkers that are associated with disease and treatment response. It is more closely related to the biological phenotype than other omics approaches, such as genomics and transcriptomics, and it has the potential to be used for precision health applications.
In this project, the investigators aim to use metabolomics to predict the response to total neoadjuvant therapy (TNT) and the incidence of treatment-related toxicity in rectal cancer patients prior to treatment. This would allow us to select patients who are most likely to benefit from TNT and to minimize the risk of complications.
There is a growing body of evidence that suggests that metabolomics can be used to predict treatment response and toxicity in cancer patients. For example, one study found that plasma metabolites could be used to predict the overall survival and progression-free survival of patients with colorectal cancer. Another study found that the level of pretreatment faecal butyrate was directly related to gastrointestinal toxicity in prostate cancer patients. However, most studies on metabolomics and cancer have used long-course chemoradiotherapy. There is a limited amount of research on the use of metabolomics to predict treatment response and toxicity to TNT.
This project is the first to comprehensively evaluate the metabolomic profiles of patients with locally advanced rectal cancer undergoing TNT at multiple time points during and after treatment using liquid chromatography-mass spectrometry (LC-MS), and to assess the association of these profiles with treatment response and toxicities. The findings from this study have the potential to lead to the development of non-invasive biomarkers for predicting treatment response and toxicities, which could improve the clinical management of rectal cancer patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Collecting biospecimens
Collecting blood, urine, tissue, and faecal samples
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled to receive total neoadjuvant therapy
Exclusion Criteria
* Inflammatory bowel disease
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linkou Chang Gung Memorial Hospital
Guishan, Taoyuan, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMRPG3P0091
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.