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

August 12, 2026 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Kian-Huat Lim, M.D.
        • Sub-Investigator:
          • Andrea Hagemann, M.D.
        • Sub-Investigator:
          • Julie Schwarz, M.D., Ph.D.
        • Sub-Investigator:
          • Hua Li, Ph.D.
        • Sub-Investigator:
          • Jessika Contreras, M.D.
        • Sub-Investigator:
          • Maggie Mullen, M.D.
        • Sub-Investigator:
          • Esther Lu, Ph.D.
        • Sub-Investigator:
          • David DeNardo, Ph.D.
        • Sub-Investigator:
          • Carl DeSelm, M.D., Ph.D.
        • Sub-Investigator:
          • Stephanie Markovina, M.D., Ph.D.
        • Sub-Investigator:
          • Matthew Powell, M.D.
        • Sub-Investigator:
          • Lindsay Kuroki, M.D.
        • Sub-Investigator:
          • Carolyn McCourt, M.D.
        • Sub-Investigator:
          • Premal Thaker, M.D.
        • Sub-Investigator:
          • Hyun Kim, M.D.
        • Sub-Investigator:
          • Dineo Khabele, M.D.
        • Sub-Investigator:
          • Albert Lai, Ph.D.
        • Sub-Investigator:
          • Philip Payne, Ph.D.
        • Sub-Investigator:
          • Doug Caruthers, M.S.
        • Sub-Investigator:
          • Lei Liu, Ph.D.
        • Sub-Investigator:
          • Brooke Sanders, M.D.
        • Sub-Investigator:
          • Leslie Stuart Massad, M.D.
        • Contact:
        • Principal Investigator:
          • Michael Waters, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Patients treated at Siteman Cancer Center that meet the eligibility criteria and sign a consent to participate in the study.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cervical Cancer
  • 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.
Other: Tumor collection via biopsy

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.

Other: Blood collection

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

Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

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.

Other Names:
  • DBSI MRI
Other: Pancreatic Cancer
  • 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.
Other: Tumor collection via biopsy

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.

Other: Blood collection

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

Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

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.

Other Names:
  • DBSI MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in tumor microenvironment
Time Frame: From start of follow-up through completion of follow-up (estimated to be 5 years)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)
The Foundation for Barnes-Jewish Hospital

Investigators

  • Principal Investigator: Michael Waters, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2024

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307103
  • U54CA274318 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting with the acceptance date of initial publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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