Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study

NCT05444647 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-07-06

No results posted yet for this study

Summary

In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.

Conditions

Interventions

PROCEDURE

stool and blood collection

Patients will collect fecal and blood samples prior to treatment and at the time of response evaluation, and completion of therapy using a standard stool-collection-kit. At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2024-05-31
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444647 on ClinicalTrials.gov