Biomarker Discovery for Toxicity and Survival in Radiation Oncology: An Integrative Molecular-Clinical Approach
Overview
- Phase
- Not Applicable
- Intervention
- laboratory biomarker analysis
- Conditions
- Adult Brain Tumor
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 273
- Locations
- 2
- Primary Endpoint
- Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients
- Status
- Completed
- Last Updated
- 19 days ago
Overview
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.
Investigators
Arnab Chakravarti
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
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
Arms & Interventions
Ancillary-Correlative
Prospectively collected blood, urine, and tissue samples are analyzed for potential predictive biomarkers via metabolomic and other molecular profiling.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients
Time Frame: 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
Time Frame: 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 Outcomes
- Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis(Baseline)