Locally Advanced Rectal CancerGMRSC-LARCNCT06375434
Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer
An observational study of Locally Advanced Rectal Cancer, run by Jing-kun Liu.
Trial summary
The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 31 Aug 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: This study will enroll 100 patients with locally advanced rectal cancer, aged 18-75, scheduled for neoadjuvant treatment. Participants will be divided into two groups of 50: one sensitive to radiotherapy and the other resistant. Each will provide stool and blood samples for metagenomic and metabolomic sequencing to investigate the gut microbiome's role in radiotherapy sensitivity. This will aid in identifying predictive biomarkers for personalized treatment strategies.
Who may be able to join
- Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,
- Pathological type is adenocarcinoma,
- Have measurable lesions before radiotherapy or chemotherapy,
- Age between 18 and 75 years,
- A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,
- An expected survival period of 6 months or more;
- Able to understand the study and sign the informed consent form.
Who cannot join
- Patients with severe complications or other malignant diseases.
- Known severe allergic reactions to components of radiotherapy or chemotherapy.
- Significant cardiac, hepatic, renal, or other vital organ dysfunction.
- Pregnant or breastfeeding women.
- Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.
- Participation in other clinical trials recently that could affect the assessment of this study's results.
About this study
Official title: The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer
The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.
Read the detailed description
The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Radiosensitive group | Not described Receives: Other: No intervention | |
| The radiotherapy-insensitive group | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of tumor
The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated
Measured: 30 days
Secondary outcomes (2)
Change in Gut Microbiota Composition
Change in gut microbiota composition, including alterations in bacterial taxa, diversity, and abundance, between rectal cancer patients sensitive to radiotherapy and a control group of patients insensitive to radiotherapy.
Measured: 30 days
Change in Plasma metabolites
Metabolomics sequencing, including profiling of metabolites and their differences, was performed on patients' plasma before radiotherapy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jing-kun Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing-kun Liu, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375434
- Sponsor's protocol ID
- 20240101-01
- Acronym
- GMRSC-LARC
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT06375434
- Acronym / sponsor ID
- GMRSC-LARC / 20240101-01
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jing-kun LiuUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 19 Apr 2024 (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.
The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy.
Detailed description
The study is expected to enroll 100 patients with locally advanced rectal cancer, including 50 patients in the radiotherapy-sensitive group and 50 in the radiotherapy-resistant group. Each participant will provide stool and blood samples before treatment for subsequent metagenomic and metabolomic sequencing analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiosensitive group | – | Other: No intervention |
| The radiotherapy-insensitive group | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will enroll 100 patients with locally advanced rectal cancer, aged 18-75, scheduled for neoadjuvant treatment. Participants will be divided into two groups of 50: one sensitive to radiotherapy and the other resistant. Each will provide stool and blood samples for metagenomic and metabolomic sequencing to investigate the gut microbiome's role in radiotherapy sensitivity. This will aid in identifying predictive biomarkers for personalized treatment strategies.
Key inclusion criteria (7 listed)
- Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,
- Pathological type is adenocarcinoma,
- Have measurable lesions before radiotherapy or chemotherapy,
- Age between 18 and 75 years,
- A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,
Key exclusion criteria (6 listed)
- Patients with severe complications or other malignant diseases.
- Known severe allergic reactions to components of radiotherapy or chemotherapy.
- Significant cardiac, hepatic, renal, or other vital organ dysfunction.
- Pregnant or breastfeeding women.
- Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.
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 |
|---|---|---|
| No interventionNo intervention | Other | Radiosensitive group, The radiotherapy-insensitive group |
Primary outcome
Diameter of tumor
Time frame: 30 days
The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated
2 secondary outcomes
Change in Gut Microbiota Composition
Time frame: 30 days
Change in Plasma metabolites
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Rectal Cancer, run by Jing-kun Liu.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of tumor (time frame: 30 days). 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 19 Apr 2024.