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CompletedNCT02259218Updated Apr 13, 2026

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

An observational study in Adult Brain Tumor, Lung Cancer and Radiation Toxicity, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
273
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Adult Brain Tumor
  • Lung Cancer
  • Radiation Toxicity

Keywords

  • Biomarker
  • Radiation
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 273 is above the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Being an inmate
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
273 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • Otherlaboratory biomarker analysis

    Correlative studies

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What researchers measure

Primary outcomes

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

    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).

    Time frame: Baseline

  2. Potential predictive biomarkers for the development of radiation necrosis for brain cancer patients

    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).

    Time frame: Baseline

Secondary outcomes

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

    Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.

    Time frame: Baseline

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Study locations

1 site
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    Columbus, Ohio 43210, United States
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02259218
Lead sponsor
Ohio State University Comprehensive Cancer Center
Responsible party
Arnab Chakravarti (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Oct 8, 2014
Start date
Oct 4, 2012
Primary completion
Sep 17, 2025
Completion
Sep 17, 2025
Last update
Apr 13, 2026

Study contacts

Arnab Chakravarti, MD
principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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