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NCT01050725 Clinical Trial

Pilot Study of Biomarkers for Radiation Therapy

Cancer Clinical Trial

Official title:
Investigating Proteomic Biomarkers of Radiation Therapy Outcome: A Pilot Study

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT01050725
Other study ID # IRB09016
Secondary ID
Status Suspended
Phase N/A
First received January 13, 2010
Last updated June 29, 2011
Start date November 2009

Study information
Verified date June 2011
Source Benaroya Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 100
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (3)
Lead Sponsor Collaborator
Benaroya Research Institute Fred Hutchinson Cancer Research Center, Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

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