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

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Brief Title

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

Official Title

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

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 massspectrometry, array, and sequencing-based technology.
    


Study Type

Observational


Primary Outcome

Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients

Secondary Outcome

 Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis

Condition

Adult Brain Tumor

Intervention

laboratory biomarker analysis

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

360

Start Date

October 4, 2012

Completion Date

December 30, 2017

Primary Completion Date

December 30, 2017

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
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Arnab Chakravarti, MD, 1-800-293-5066, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02259218

Organization ID

OSU-11108

Secondary IDs

NCI-2014-01575

Responsible Party

Principal Investigator

Study Sponsor

Ohio State University Comprehensive Cancer Center


Study Sponsor

Arnab Chakravarti, MD, Principal Investigator, Ohio State University Comprehensive Cancer Center


Verification Date

April 2017