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

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: Cervical Cancer; Pancreatic Cancer; Pancreas Cancer; Locally Advanced Cervical Carcinoma; Locally Advanced Cervical Cancer; Cancer of the Pancreas; Locally Advanced Pancreatic Carcinoma; Locally Advanced Pancreatic Cancer; Cancer of the Cervix; Locally Advanced Pancreas Cancer
• Intervention / Treatment: Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cliff Robinson, M.D.; Phone Number: 314-362-8567; Email: clifford.robinson@wustl.edu

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.
      • Contact: Cliff Robinson, M.D.; Phone Number: 314-362-8567; Email: clifford.robinson@wustl.edu
      • Principal Investigator: Cliff Robinson, 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI); The Foundation for Barnes-Jewish Hospital
• Investigators: Principal Investigator: Cliff Robinson, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

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): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Radiotherapy; Chemotherapy; Pancreatic cancer; Cervical cancer; Biospecimen
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Pancreatic Neoplasms; Uterine Cervical Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Blood Specimen Collection
• 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