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
• Interventions: Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)

• 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

Arm && Interventions

Group	Intervention	Description
Cervical Cancer	Tumor collection via biopsy	* 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	Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)	* 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.
Cervical Cancer	Blood collection	* 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	Tumor collection via biopsy	* 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.
Cervical Cancer	Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)	* 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	Blood collection	* 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.

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