We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Pilot Study of Biomarkers for Radiation Therapy

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: NCT01050725
Recruitment Status : Suspended (On hold: pending grant funding for further enrollment)
First Posted : January 15, 2010
Last Update Posted : June 30, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study
Study Start Date : November 2009
Estimated Primary Completion Date : June 2013
Groups and 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.

Outcome Measures

Biospecimen Description:
whole blood samples.

Eligibility Criteria

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

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): NCT01050725

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
Principal Investigator: Kas R Badiozamani, MD Virginia Mason Hospital/Medical Center
More Information

Responsible Party: Kas Badiozamani, Virginia mason Medical Center
ClinicalTrials.gov Identifier: NCT01050725     History of Changes
Other Study ID Numbers: IRB09016
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: June 30, 2011
Last Verified: June 2011

Keywords provided by Benaroya Research Institute: