Metabolomic and Epigenetic Profiling of Bodyfluids From Lung and Brain Cancer Receiving Radiation Therapy

Active, not recruiting

• Conditions: Adult Brain Tumor; Lung Cancer; Radiation Toxicity
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT02259218
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

This research trial studies metabolomic and other molecular profiling to identify predictive biomarkers for radiation toxicity and survival in patients with lung or brain cancers receiving radiation therapy. Studying samples of blood, urine, and tissue from patients with lung or brain cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict which patients are at higher risk for developing radiation side effects and how well patients will respond to radiation treatment.

Detailed Description

PRIMARY OBJECTIVES:

I. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for lung cancer associated with the development of radiation pneumonitis.

II. Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for brain cancer associated with the development of radiation necrosis.

SECONDARY OBJECTIVES:

I. Metabolomic and epigenetic urine, blood, and tissue profiles of patients undergoing radiation therapy for lung and brain cancer associated with survival.

OUTLINE:

Collected blood, urine, and tissue samples are analyzed for biomarkers via metabolomic and epigenetic profiling using mass spectrometry, array, and sequencing-based technology.

Study Timeline

• Study Start: 2012-10-04
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-10-05
• Study First Posted: 2014-10-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Consultation with the Radiation Oncology department of the Ohio State University (OSU) Comprehensive Cancer Center
• The following diagnoses will be included: malignant neoplasm of the brain; primary malignant neoplasm of trachea bronchus and lung; primary malignant neoplasm of the cervix uteri and primary malignant neoplasm the prostate

Exclusion Criteria

• Being an inmate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative	laboratory biomarker analysis	Prospectively collected blood, urine, and tissue samples are analyzed for potential predictive biomarkers via metabolomic and other molecular profiling.

Primary Outcome Measures

Name	Time	Method
Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients	Baseline	For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).
Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients	Baseline	For each biomarker, linear mixed model (with group and time interaction and repeated measurement for each patient over time) on the log-transformed expression level will be used to detect if it is differentially expressed after controlling for the effects of the co-variates (such as age, disease status, and treatment details).

Secondary Outcome Measures

Name	Time	Method
Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis	Baseline	Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.

Trial Locations

Locations (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States