Correlation Between Gut Microbiota and Radiosensitivity o... | NCT06375434

Studies
Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer

NCT06375434

Sponsor

Jing-kun Liu

Status

Unknown status

Last Update Posted

Apr 19, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Locally Advanced Rectal Cancer

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Estimated

Primary Completion Date

Aug 15, 2024Estimated

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Apr 12, 2024

First Submission Date that Met QC Criteria

Apr 16, 2024

First Posted Date

Apr 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Radiosensitive group			Other: No intervention
The radiotherapy-insensitive group			Other: No intervention

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Radiosensitive group The radiotherapy-insensitive group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diameter of tumor	The tumor diameter before and after radiotherapy and the reduced tumor diameter after treatment were calculated	30 days

Secondary Outcomes

Measure	Description	Time Frame
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
Change in Plasma metabolites

Other Outcomes

Measure	Description	Time Frame
Five-year survival rate		5 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample