Study of DNA Mutations in Predicting the Effect of External-Beam Radiation Therapy in Patients With Early Breast Cancer, Localized Prostate Cancer, or Gynecological Cancer

August 23, 2013 updated by: The Christie NHS Foundation Trust

Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is evaluating DNA mutations in predicting the effect of external-beam radiation therapy in patients with early breast cancer, localized prostate cancer, or gynecologic cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To test the hypothesis that an association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, is associated with individual patient variability in normal tissue radiation response and toxicity.

Secondary

  • To compare different clinical scoring systems for late normal tissue effects, specifically Late Effect of Normal Tissue Subjective Objective Management Analysis (LENT SOMA), Radiation Therapy Oncology Group (RTOG), quality of life, and in a subset common terminology criteria (CTC) version 3.
  • To compare clinical scoring systems with analytical measures of normal tissue outcome in a minority of patients, using volume change in the breast measured by laser camera.
  • To correlate family history information with SNP analysis to produce a polymorphism risk score (PRS) for family history.
  • To compare a detailed 3D dose-volume analysis in a subset of patients with late effects and SNP results.
  • To correlate actuarial analysis of late effects changes over time with PRS.
  • To conduct PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability.

OUTLINE: This is a multicenter study.

Patients are recruited from clinical trials in which their late normal tissue effects have been measured. Blood samples are collected from these patients for analysis of genetic variation by DNA extraction and single nucleotide polymorphism analysis. Sixty different genes, including those involved in cell cycle checkpoint control, DNA damage recognition and repair, induction of apoptosis, and cytokine production (including TGFβ pathways) are assessed.

Study Type

Interventional

Enrollment (Anticipated)

2200

Phase

  • Not Applicable

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 Kingdom
    • England
      • Brighton, England, United Kingdom, BN2 5BE
        • Recruiting
        • Sussex Cancer Centre at Royal Sussex County Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-12-7369-6955
      • Bristol, England, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Haematology and Oncology Centre
        • Contact:
          • Contact Person
          • Phone Number: 44-117-928-2415
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Recruiting
        • Addenbrooke's Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1223-336-800
      • Ipswich, England, United Kingdom, IP4 5PD
        • Recruiting
        • Ipswich Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1473-704-177
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • Christie Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-161-446-8275
      • Merseyside, England, United Kingdom, CH63 4JY
        • Recruiting
        • Clatterbridge Centre for Oncology
        • Contact:
          • Contact Person
          • Phone Number: 44-151-334-1155
      • Prescot, England, United Kingdom, L35 5DR
        • Recruiting
        • Whiston Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-151-334-1155
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Recruiting
        • Cancer Research Centre at Weston Park Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-114-226-5000
      • Southport, England, United Kingdom, PR8 6PN
        • Recruiting
        • Southport and Formby District General Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-151-334-1155
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden - Surrey
        • Contact:
          • Contact Person
          • Phone Number: 44-20-8661-3271
      • Warrington, England, United Kingdom, WA5 1QG
        • Recruiting
        • Warrington Hospital NHS Trust
        • Contact:
          • Contact Person
          • Phone Number: 44-151-334-1155

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

Description

DISEASE CHARACTERISTICS:

  • Patients must have received curative external-beam radiotherapy within the context of a formal clinical study for any of the following:

    • Early breast cancer after breast-conserving surgery
    • Localized prostate cancer
    • Gynecological cancer (may have also received brachytherapy)
  • Venous blood samples must be available

  • Patients will be identified from the following clinical studies:

    • Cambridge intensity-modulated radiotherapy breast randomized trial
    • RT01 prostate radiotherapy randomized trial/other prostate trials
    • Christie hospital breast, prostate, and gynecological cancer radiotherapy patients
  • Must have minimum follow up with late normal tissue effect scoring for two years available

PATIENT CHARACTERISTICS:

  • No other malignancy prior to treatment for the specified tumor types except basal cell or squamous cell carcinoma of the skin or in situ carcinoma

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

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Correlation of association between common genetic variations, reported by single nucleotide polymorphisms (SNP) in relevant candidate genes, with individual patient variability in normal tissue radiation response and toxicity

Secondary Outcome Measures

Outcome Measure
Comparison of different clinical scoring systems for late normal tissue effects
Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera
Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS)
Comparison of detailed 3D dose-volume analysis with late effects and SNP results
Correlation of actuarial analysis of late effects changes over time with PRS
PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability

Collaborators and Investigators

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

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Catherine West, The Christie NHS Foundation Trust

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

March 1, 2006

Primary Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000581139
  • CHNT-RAPPER
  • EU-20798

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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