Molecular Markers and Genetic Markers in Patients Undergoing Radiation Therapy for Cancer

May 27, 2015 updated by: Rutgers, The State University of New Jersey

Molecular and Genetic Markers in the Local-regional Management of Patients Undergoing Radiation Therapy

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at molecular markers and genetic markers in patients undergoing radiation therapy for cancer.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

OBJECTIVES:

Primary

  • Determine local-regional control in patients undergoing radiation therapy for cancer, as a function of expression of specific molecular/genetic markers.

Secondary

  • Determine complications of radiation therapy for patients undergoing radiation therapy for cancer.

OUTLINE: Previously collected tissue samples are analyzed using immunohistochemical staining and other molecular/genetic study methods to detect markers, including p53, cyclin D1, HER-2-neu, bcl-2/BAX, and EGFR. Patient charts are also reviewed with emphasis on local-regional relapse.

Study Type

Observational

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
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey - Robert Wood Johnson Medical School

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing radiation therapy for malignant disease will be eligible for these studies. Initially we will focus on specific disease sites, such as breast, prostate and lung, but ultimately we will expand this to include any disease site. Patients who met standard criteria for radiation therapy but ultimately did not receive radiation therapy will be used as a control arm if needed.

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Undergoing radiation therapy for malignant disease

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Collaborators and Investigators

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

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Investigators

  • Principal Investigator: Bruce G. Haffty, MD, Rutgers Cancer Institute of New Jersey- Robert Wood Johnson Medical School

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

May 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000609
  • P30CA072720 (U.S. NIH Grant/Contract)
  • CDR0000592887
  • CINJ-IRB-0220060141

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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