Pilot Study of Biomarkers for Radiation Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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proteome biomarkers radiotherapy cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Virginia mason Medical Center

Principal Investigators

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Kas R Badiozamani, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Hospital/Medical Center

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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IRB09016

Identifier Type: -

Identifier Source: org_study_id