Rectal Neoplasm MalignantNCT06831669
Metabolomics to Predict Treatment Response and Toxicities in Rectal Cancer
An observational study of Rectal Neoplasm Malignant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rectal Neoplasm Malignant
- What is being tested?
- Collecting biospecimens
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2024to 12 Dec 2033
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Histologically confirmed adenocarcinoma of the rectum
- Scheduled to receive total neoadjuvant therapy
Who cannot join
- Previous pelvic radiation therapy
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Guishan, Taoyuan, 333
Eric Yi-Liang Shen, MD, PhD, +886-975366392, pts@cgmh.org.tw
Yu-Hsien Chou, MS, +886-935667922, yhc1228@cgmh.org.tw
About this study
Official title: Metabolomic Profiles as Predictors of Treatment Response and Toxicities in Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy
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.
Read the detailed description
Hypothesis: Metabolomic profiling can be used to predict the response to total neoadjuvant therapy (TNT) and the incidence of radiotherapy-related diarrhoea in patients with locally advanced rectal cancer.
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
- Rectal Neoplasm Malignant
- Being tested
- Collecting biospecimens
- Keywords
- Rectal cancer, Total neoadjuvant therapy, Metabolomics, Radiation proctitis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting biospecimensOther
Collecting blood, urine, tissue, and faecal samples
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Incidence of severe (Grade 3-4) toxicities associated with radiotherapy, as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0).
Measured: From initiation of radiotherapy to 21 days after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start5 Jan 2024
- Primary completion12 Dec 2028 (estimated)
- Study completion12 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831669
- Sponsor's protocol ID
- CMRPG3P0091
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Profiles as Predictors of Treatment Response and Toxicities in Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06831669
- Acronym / sponsor ID
- CMRPG3P0091
- Conditions
- Rectal Neoplasm Malignant
- Keywords
- Rectal cancer, Total neoadjuvant therapy, Metabolomics, Radiation proctitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 12 Dec 2028 (estimated)
- Study completion
- 12 Dec 2033 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hypothesis: Metabolomic profiling can be used to predict the response to total neoadjuvant therapy (TNT) and the incidence of radiotherapy-related diarrhoea in patients with locally advanced rectal cancer.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Histologically confirmed adenocarcinoma of the rectum
- Scheduled to receive total neoadjuvant therapy
Key exclusion criteria (2 listed)
- Previous pelvic radiation therapy
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting biospecimensCollecting blood, urine, tissue, and faecal samples | Other | – |
Primary outcome
Predictive Accuracy of Metabolomic Profiles for Complete Response (CR)
Time frame: From enrollment to surgical resection or up to 6 months after completion of radiotherapy (whichever occurs first)
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.
1 secondary outcome
Number of Participants With Grade 3-4 Treatment-Related Toxicities as Assessed by CTCAE
Time frame: From initiation of radiotherapy to 21 days after completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasm Malignant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Yi-Liang Shen, PhD (0975366392, pts@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Accuracy of Metabolomic Profiles for Complete Response (CR) (time frame: From enrollment to surgical resection or up to 6 months after completion of radiotherapy (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.