Pilot Study of Biomarkers for Radiation Therapy

NCT01050725 | Suspended DMC

• 1 other identifier: IRB09016
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

proteome; biomarkers; radiotherapy; cancer

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator
• Fred Hutchinson Cancer Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Biospecimen

whole blood samples.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kas R Badiozamani, MD

  Virginia Mason Hospital/Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: November 1, 2009
• Primary Completion: June 1, 2013
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

US (1)