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NCT05975593 Clinical Trial

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Pancreatic Cancer Clinical Trial

— METEOR-CRATR  

Official title:
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05975593
Other study ID # 202307103
Secondary ID U54CA274318
Status Recruiting
Phase
First received
Last updated
Start date December 19, 2023
Est. completion date December 31, 2032

Study information
Verified date June 2024
Source Washington University School of Medicine
Contact Cliff Robinson, M.D.
Phone 314-362-8567
Email clifford.robinson@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment (imaging, dosimetry, clinical) data before, during, and after treatment with definitive-intent standard of care (SOC) radiotherapy for patients with locally advanced cervical and pancreatic cancer.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2032
Est. primary completion date December 31, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmation of intent to receive standard of care radiotherapy for one of the following diagnoses: - Locally advanced or metastatic cervical cancer - Locally advanced or metastatic pancreatic cancer - ECOG performance status = 2 - At least 18 years old - Able to understand and willing to sign an IRB-approved written informed consent document Exclusion Criteria: - Co-enrollment to another therapeutic study receiving investigational agent - Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in tumor microenvironment Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time. From start of follow-up through completion of follow-up (estimated to be 5 years)
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