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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259218
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Arnab Chakravarti, 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.

Condition or disease Intervention/treatment
Adult Brain Tumor Lung Cancer Radiation Toxicity Other: laboratory biomarker analysis

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.

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Study Type : Observational
Actual Enrollment : 273 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Biomarker Discovery for Toxicity and Survival in Radiation Oncology: An Integrative Molecular-Clinical Approach
Actual Study Start Date : October 4, 2012
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis [ Time Frame: Baseline ]
    Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.


Biospecimen Retention:   Samples With DNA
Blood, urine, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with lung, brain, prostate or cervical cancer that are being treated with radiation therapy.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259218


Locations
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United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Arnab Chakravarti, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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Responsible Party: Arnab Chakravarti, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02259218    
Other Study ID Numbers: OSU-11108
NCI-2014-01575 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arnab Chakravarti, Ohio State University Comprehensive Cancer Center:
Biomarker
Radiation