Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

Locally Advanced Rectal Cancer Clinical Trial

— GMRSC-LARC  

Official title:

The Mechanistic Study on the Influence of Gut Microbiota on Radiotherapy Sensitivity in Patients With Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375434
• Other study ID #: 20240101-01
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Xinjiang Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 15, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jing-kun Liu

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Five-year survival rate		5 year
Primary	Diameter of tumor	The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated	30 days
Secondary	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.	30 days
Secondary	Change in Plasma metabolites	Metabolomics sequencing, including profiling of metabolites and their differences, was performed on patients' plasma before radiotherapy.	30 days