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Response and Toxicity Prediction by Microbiome Analysis After (Concurrent) Chemoradiotherapy

NCT04711330 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2025-10-06

No results posted yet for this study

Summary

The predictive value of the microbiome (throat swabs, stool and of bronchial samples) to identify patients who will relapse during durvalumab treatment after CRT (False negative Rate) at 6 months. Exploratory endpoints include the effects of antibiotic therapy before and during IO treatment on toxicity and response rate. The role of exhaled breath analysis in prediction of response and toxicity will also be investigated.

Conditions

  • Non Small Cell Lung Cancer Stage III
  • Immunotherapy

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Jessa Hospital

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Paul Baas, MD PhD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-10-01
Completion
2025-10-02

Countries

  • Belgium
  • Netherlands

Study Locations

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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 NCT04711330 on ClinicalTrials.gov