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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

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  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
Official Title  Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)
Brief Summary

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.

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 Phase
Study Type  Interventional
Study Design  Treatment, Open Label
Primary 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 [ Designated as safety issue: No ]
Secondary Outcome Measure  Comparison of different clinical scoring systems for late normal tissue effects [ Designated as safety issue: Yes ]
Comparison of clinical scoring systems with analytical measures of normal tissue outcome using volume change in the breast measured by laser camera [ Designated as safety issue: Yes ]
Correlation of family history information with SNP analysis to produce a polymorphism risk score (PRS) [ Designated as safety issue: No ]
Comparison of detailed 3D dose-volume analysis with late effects and SNP results [ Designated as safety issue: No ]
Correlation of actuarial analysis of late effects changes over time with PRS [ Designated as safety issue: No ]
PRS analyses against tumor control probability (TCP), using survival as a surrogate for TCP where necessary, and normal tissue complications vs tumor control probability [ Designated as safety issue: No ]
Condition  Breast Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Prostate Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Intervention  Procedure: gene expression analysis
Procedure: gene rearrangement analysis
Procedure: laboratory biomarker analysis
Procedure: polymorphism analysis
Procedure: radiation therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  2200
Start Date  March 2006
Completion Date
Eligibility Criteria 

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
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00601406
Organization ID CDR0000581139
Secondary IDs †† CHNT-RAPPER, EU-20798
Study Sponsor  Christie Hospital
Collaborators ††
Investigators 
Study Chair:     Catherine West     Christie Hospital    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  January 25, 2008
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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