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

April 22, 2024 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 (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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

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
      • Saint 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:
          • Ryan Fields, M.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.
        • Contact:
        • Principal Investigator:
          • Cliff Robinson, M.D.
        • Sub-Investigator:
          • Jeff Szymanski, 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.

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

Sampling Method

Non-Probability Sample

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 standard of care radiotherapy for one of the following diagnoses:

    • Locally advanced or metastatic cervical cancer (FIGO stage IB3-IV)
    • Locally advanced or metastatic pancreatic cancer (AJCC 8th ed stage IB-IV)
  • 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 examining non-standard of care therapy of any kind
  • 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

Cohorts and Interventions

Group / Cohort
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.
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.

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)

Investigators

  • Principal Investigator: Cliff Robinson, M.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)

December 19, 2023

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)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

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

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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