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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02259218
Enrollment
273
Registered
2014-10-08
Start date
2012-10-04
Completion date
2025-09-17
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Brain Tumor, Lung Cancer, Radiation Toxicity

Keywords

Biomarker, Radiation

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patientsBaselineFor 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 patientsBaselineFor 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

MeasureTime frameDescription
Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysisBaselineKaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArnab Chakravarti, MD

Ohio State University Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026