Skip to main content
OpenTrials
Completed

NCT Number: NCT02259218

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radiation Injuries Radiation Toxicity Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2014
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.