Pilot Study of Biomarkers for Radiation Therapy

June 29, 2011 updated by: Benaroya Research Institute

Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study

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.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98111
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benaroya Research Institute

Collaborators

Fred Hutchinson Cancer Center
Virginia Mason Hospital/Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 30, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB09016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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