Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breath Test for Biomarkers in Humans Receiving Total Body Irradiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152722
Recruitment Status : Unknown
Verified April 2015 by Menssana Research, Inc..
Recruitment status was:  Recruiting
First Posted : June 2, 2014
Last Update Posted : April 7, 2015
Sponsor:
Collaborators:
Department of Health and Human Services
Memorial Sloan Kettering Cancer Center
Emory University
Hackensack Meridian Health
Information provided by (Responsible Party):
Menssana Research, Inc.

Brief Summary:

The effect of radiation on normal tissue varies widely between individuals. Consequently, a test to measure tissue response to radiation could be clinically useful by permitting more accurate titration of dosage in patients undergoing radiotherapy. Also, in view of emerging concerns about possible nuclear terrorism a test for exposure to radiation might also be useful in evaluating victims of a "dirty bomb" explosion. A number of different techniques have been previously reported in epidemiological studies for the estimation of prior radiation exposure. This study explores one approach to estimating radiation exposure by measurement of increased oxidative stress which can be detected by a breath test.

In this study subjects undergoing significant exposure to therapeutic radiation will provide breath samples for analysis in a central laboratory. The hypothesis of the study is that the analysis of these samples will lead to the identification of a set of markers of radiation exposure.


Condition or disease
Radiation Injury

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Breath Test for Biomarkers in Humans Receiving Total Body Irradiation
Study Start Date : September 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : November 2016

Group/Cohort
Total Body Irradiation Subjects
Subjects undergoing total body irradiation prior to chemotherapy. It is expected that all of these subjects will be receiving ablative radiation prior to bone marrow transplant. Breath will be collected before and after the first radiation exposure on each day of total body irradiation.



Primary Outcome Measures :
  1. Radiation volatile organic compound (VOC) score [ Time Frame: Each day of radiation exposure at time points between 1 day and 7 days post exposure. ]
    An algorithm for scoring the radiation exposure based on analysis of breath samples will be developed and applied to each breath sample collected. The hypothesis is that the scores will indicate radiation exposure, specifically exposure to more than 2 Gray at time points between 1 day and 7 days post exposure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing total body irradiation prior to chemotherapy.
Criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Subject is willing and able to cooperate with study and give signed informed consent to participate
  3. Subject has been diagnosed with a condition that requires treatment with a TBI protocol of daily irradiation for one to five days
  4. Actively smoking subjects, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded
  5. Subject will be available for follow-up breath tests following each session of TBI. Subjects receiving only one day of TBI will be available for a follow-up 24-36 hours following TBI
  6. Subject is an in-patient at the hospital

Exclusion Criteria:

1. Subject has had chemotherapy within preceding 21 days


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152722


Contacts
Layout table for location contacts
Contact: Michael Phillips, MD 973-643-5464 mphillips@menssanaresearch.com
Contact: Peter Kaplan, PhD 973-643-5464 pkaplan@menssanaresearch.com

Locations
Layout table for location information
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mohammad Khan, M.D.         
Principal Investigator: Mohammad Khan, M.D.         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Scott Rowly, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Principal Investigator: Chris Barker, M.D.         
Sponsors and Collaborators
Menssana Research, Inc.
Department of Health and Human Services
Memorial Sloan Kettering Cancer Center
Emory University
Hackensack Meridian Health
Investigators
Layout table for investigator information
Principal Investigator: Michael Phillips, M.D. Menssana Research, Inc.

Publications:
Layout table for additonal information
Responsible Party: Menssana Research, Inc.
ClinicalTrials.gov Identifier: NCT02152722     History of Changes
Other Study ID Numbers: MR 2012 TBI
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Menssana Research, Inc.:
Breath test
Volatile Organic Compounds
VOC
oxidative stress
radiation biodosimetry
metabolomics
GCxGC TOF-MS
Additional relevant MeSH terms:
Layout table for MeSH terms
Radiation Injuries
Wounds and Injuries