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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02259218

Collaborator

(none)

273

Enrollment

Location

122.8

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Brain Tumor Lung Cancer Radiation Toxicity	Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for lung cancer associated with the development of radiation pneumonitis.
Metabolomic and epigenetic urine and blood profiles of patients undergoing radiation therapy for brain cancer associated with the development of radiation necrosis.

SECONDARY OBJECTIVES:

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 Design

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 :

Oct 4, 2012

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Correlative studies

Arm

Intervention/Treatment

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

Correlative studies

Outcome Measures

Primary Outcome Measures

Potential predictive biomarkers for the development of radiation pneumonitis for lung cancer patients [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 [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 Outcome Measures

Biomarkers that are prognostically significant on disease free or overall survival, identified using the survival analysis [Baseline]
Kaplan Meier analysis and logrank test to identify biomarkers that are prognostically significant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Investigators

Principal Investigator: Arnab Chakravarti, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

The Jamesline

Publications

None provided.

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

First Posted:

Oct 8, 2014

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arnab Chakravarti, Principal Investigator, Ohio State University Comprehensive Cancer Center

Biomarker

Radiation

Study Results

No Results Posted as of Mar 16, 2021