Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

NCT06375434 | Not Yet Recruiting

• 1 other identifier: 20240101-01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Diameter of tumor

  The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated

  30 days

Secondary Outcomes (2)

• Change in Gut Microbiota Composition

  30 days

• Change in Plasma metabolites

  30 days

Other Outcomes (1)

• Five-year survival rate

  5 year

Study Arms (2)

Radiosensitive group

Other: No intervention

The radiotherapy-insensitive group

Other: No intervention

Interventions

No intervention OTHER

No intervention

Radiosensitive group; The radiotherapy-insensitive group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing-kun Liu: lead

Biospecimen

Retention: SAMPLES WITH DNA

Feces；Blood

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 19, 2024
• Study Start: May 15, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 31, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04