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NCT Number: NCT05975593

MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Albert Lai, Ph.D.

SUB_INVESTIGATOR

Andrea Hagemann, M.D.

SUB_INVESTIGATOR

Brooke Sanders, M.D.

SUB_INVESTIGATOR

Carl DeSelm, M.D., Ph.D.

SUB_INVESTIGATOR

Carolyn McCourt, M.D.

SUB_INVESTIGATOR

Cliff Robinson, M.D.

CONTACT

[email protected]

314-362-8567

Cliff Robinson, M.D.

PRINCIPAL_INVESTIGATOR

David DeNardo, Ph.D.

SUB_INVESTIGATOR

Dineo Khabele, M.D.

SUB_INVESTIGATOR

Doug Caruthers, M.S.

SUB_INVESTIGATOR

Esther Lu, Ph.D.

SUB_INVESTIGATOR

Hua Li, Ph.D.

SUB_INVESTIGATOR

Hyun Kim, M.D.

SUB_INVESTIGATOR

Jessika Contreras, M.D.

SUB_INVESTIGATOR

Julie Schwarz, M.D., Ph.D.

SUB_INVESTIGATOR

Kian-Huat Lim, M.D.

SUB_INVESTIGATOR

Lei Liu, Ph.D.

SUB_INVESTIGATOR

Leslie Stuart Massad, M.D.

SUB_INVESTIGATOR

Lindsay Kuroki, M.D.

SUB_INVESTIGATOR

Maggie Mullen, M.D.

SUB_INVESTIGATOR

Matthew Powell, M.D.

SUB_INVESTIGATOR

Philip Payne, Ph.D.

SUB_INVESTIGATOR

Premal Thaker, M.D.

SUB_INVESTIGATOR

Stephanie Markovina, M.D., Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor collection via biopsy

Other

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.

Blood collection

Other

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

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

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cliff Robinson, M.D.

CONTACT

[email protected]

314-362-8567

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Acronym: METEOR-CRATR

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Aug 4, 2023
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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