MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer; Locally Advanced Pancreatic Carcinoma; Cervical Cancer; Locally Advanced Pancreatic Cancer; Pancreas Cancer; Cancer of the Pancreas; Locally Advanced Cervical Cancer; Locally Advanced Pancreas Cancer; Cancer of the Cervix; Locally Advanced Cervical Carcinoma

• Registration Number: NCT05975593
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-04
• Study Start: 2024-01-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in tumor microenvironment	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States