Pilot Study of Biomarkers for Radiation Therapy

This study has suspended participant recruitment.
(On hold: pending grant funding for further enrollment)
Sponsor:
Collaborators:
Virginia Mason Hospital/Medical Center
Fred Hutchinson Cancer Research Center
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT01050725
First received: January 13, 2010
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to determine whether specific assays of DNA damage repair proteins can be used in patients undergoing radiation therapy. The ultimate goal of this research is to develop clinically useful biomarkers from blood samples that could be used to customize radiation treatment for individuals, leading to reduced side effects and improved outcomes.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study

Further study details as provided by Benaroya Research Institute:

Biospecimen Description:

whole blood samples.


Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Radiation therapy patients
Individuals receiving radiation therapy as definitive or neo-adjuvant therapy for selected malignancies, including head and neck, lung, esophageal, rectal cervical and prostate cancers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing radiation for selected malignancies, including head and neck, lung, esophageal, rectal, cervical and prostate cancers.

Criteria

Inclusion Criteria:

  • patients > 18 years of age with primary lung, esophageal or rectal cancer receiving neo-adjuvant chemoradiotherapy before planned resection
  • patients with clinically localized prostate cancer receiving definitive radiation therapy with external beam treatment. brachytherapy as a boost and/or hormonal therapy are allowed.
  • patients with head and neck, lung, esophageal or cervical cancer who will receive definitive radiotherapy

Exclusion Criteria:

  • prior history of chemotherapy given within 6 months before enrollment.
  • prior radiotherapy or radionuclide treatment and/or brachytherapy within 6 months prior to enrollment.
  • unwillingness to comply with tests, protocol, or informed consent.
  • concurrent enrollment on any protocol that would require non-compliance with treatment procedures.
  • chemotherapy required within 2 hours following first dose of XRT.
  • PET scan done within 48 hours of first blood draw.
  • nuclear medicine exposure within 4 days prior to first draw.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050725

Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Sponsors and Collaborators
Benaroya Research Institute
Virginia Mason Hospital/Medical Center
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Kas R Badiozamani, MD Virginia Mason Hospital/Medical Center
  More Information

No publications provided

Responsible Party: Kas Badiozamani, Virginia mason Medical Center
ClinicalTrials.gov Identifier: NCT01050725     History of Changes
Other Study ID Numbers: IRB09016
Study First Received: January 13, 2010
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Benaroya Research Institute:
proteome
biomarkers
radiotherapy
cancer

ClinicalTrials.gov processed this record on October 19, 2014