Clinical trial NCT06375434: Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer
Official title: The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Locally Advanced Rectal Cancer
Lead sponsor: Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with late-stage rectal cancer (stages IIIB to IV), including those with postoperative recurrence re-staging or those intending to receive neoadjuvant treatment,
2. Pathological type is adenocarcinoma,
3. Have measurable lesions before radiotherapy or chemotherapy,
4. Age between 18 and 75 years,
5. A WHO Performance Status (PS) score of 0 to 2, capable of tolerating radiotherapy or chemotherapy,
6. An expected survival period of 6 months or more;
7. Able to understand the study and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe complications or other malignant diseases.
2. Known severe allergic reactions to components of radiotherapy or chemotherapy.
3. Significant cardiac, hepatic, renal, or other vital organ dysfunction.
4. Pregnant or breastfeeding women.
5. Patients unable to comply with study requirements or affected by psychiatric or psychological diseases.
6. Participation in other clinical trials recently that could affect the assessment of this study's results.

Primary outcomes:
measure: Diameter of tumor
timeFrame: 30 days
Secondary outcomes:
measure: Change in Gut Microbiota Composition
timeFrame: 30 days
measure: Change in Plasma metabolites
timeFrame: 30 days
Other outcomes:
measure: Five-year survival rate
timeFrame: 5 year
Locations:
Study officials:
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