MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial
METEOR-CRATR
2 other identifiers
interventional
60
1 country
1
Brief Summary
This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedStudy Start
First participant enrolled
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
November 12, 2025
November 1, 2025
9 years
July 24, 2023
November 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Cervical Cancer
OTHER* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
Pancreatic Cancer
OTHER* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI.
Interventions
Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.
Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence
Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible.
Eligibility Criteria
You may qualify if:
- Confirmation of intent to receive radiotherapy for one of the following diagnoses:
- Cervical cancer
- 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
You may not qualify if:
- Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- National Cancer Institute (NCI)collaborator
- The Foundation for Barnes-Jewish Hospitalcollaborator
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cliff Robinson, M.D.
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 4, 2023
Study Start
January 11, 2024
Primary Completion (Estimated)
December 31, 2032
Study Completion (Estimated)
December 31, 2032
Last Updated
November 12, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Starting with the acceptance date of initial publication.
- Access Criteria
- Scientific progress and publications will be posted on the METEOR website. The respective departments of the PIs and co-Is also maintain web sites where information and links on the investigators' work are posted. The PIs and co-Is additionally have lab web sites where summaries of the scientific progress on projects and research interests are posted.
Data will be presented at scientific meetings \& published in journals. Individual-level \& aggregate genomic data will be deposited/made available through GEO \& SRA. Includes sequence, transcriptomic, epigenomic, \& gene expression data. Raw mass spectra \& unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE \& ProteomeEXchange to share protein identifications \& spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH \& institutional regulations. BLST will manage \& assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.