Clinical trial NCT02259218: Metabolomic and Epigenetic Profiling of Bodyfluids From Lung and Brain Cancer Receiving Radiation Therapy
Official title: Biomarker Discovery for Toxicity and Survival in Radiation Oncology: An Integrative Molecular-Clinical Approach
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adult Brain Tumor
Lung Cancer
Radiation Toxicity
Keywords: Biomarker
Radiation
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with lung, brain, prostate or cervical cancer that are being treated with radiation therapy.

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.

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

Primary outcomes:
measure: Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients
timeFrame: Baseline
measure: Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients
timeFrame: Baseline
Secondary outcomes:
measure: Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Arnab Chakravarti, MD
role: PRINCIPAL_INVESTIGATOR
References: