Longitudinal Metabolomic and Epigenetic Profiling of Bodyfluids From Patients With Lung and Brain Cancer Receiving Radiation Therapy
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ClinicalTrials.gov Identifier: NCT02259218 |
Recruitment Status :
Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : March 16, 2021
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Condition or disease | Intervention/treatment |
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Adult Brain Tumor Lung Cancer Radiation Toxicity | Other: laboratory biomarker analysis |
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 |
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 |

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

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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 |
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

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
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Arnab Chakravarti, MD | Ohio State University Comprehensive Cancer Center |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Biomarker Radiation |