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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biomarker Discovery for Toxicity and Survival in Radiation Oncology: An Integrative Molecular-Clinical Approach

Conditions
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Adult Brain Tumor, Lung Cancer, Radiation Toxicity

Intervention / Treatment
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* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative<br>Prospectively collected blood, urine, and tissue samples are analyzed for potential predictive biomarkers via metabolomic and other molecular profiling. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients | 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). | Baseline | 
| Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients | 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). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis | Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarker, Radiation