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

NCT02259218 | Completed

• 2 other identifiers: OSU-11108NCI-2014-01575
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Brain Tumor; Lung Cancer; Radiation Toxicity

Keywords

Biomarker; Radiation

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline

• 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).

  Baseline

Secondary Outcomes (1)

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

  Baseline

Study Arms (1)

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

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-Correlative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with lung, brain, prostate or cervical cancer that are being treated with radiation therapy.

You may qualify if:

• 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

You may not qualify if:

• Being an inmate

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, tissue

MeSH Terms

Conditions

Brain Neoplasms; Lung Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• Arnab Chakravarti, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: October 8, 2014
• Study Start: October 4, 2012
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)