Pilot Study of Biomarkers for Radiation Therapy | NCT01050725

Studies
Pilot Study of Biomarkers for Radiation Therapy

NCT01050725

Sponsor

Benaroya Research Institute

Status

Suspended

Last Update Posted

Jun 30, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

On hold: pending grant funding for further enrollment

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2013Estimated

Completion Date

Not provided

First Submitted Date

Jan 13, 2010

First Submission Date that Met QC Criteria

Jan 13, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2011

Last Update Posted Date

Jun 30, 2011Estimated

Name	Class
Virginia Mason Hospital/Medical Center	OTHER
Fred Hutchinson Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kas R Badiozamani, MD	Virginia Mason Hospital/Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Mason Medical Center		Seattle	Washington	98111	United States