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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.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: Christie Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00601406
  Purpose

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.


Condition Intervention
Breast Cancer
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Prostate Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Procedure: gene expression analysis
Procedure: gene rearrangement analysis
Procedure: laboratory biomarker analysis
Procedure: polymorphism analysis
Procedure: radiation therapy

Genetics Home Reference related topics:   Soft Tissue Sarcoma   breast cancer  

MedlinePlus related topics:   Breast Cancer   Cancer   Cervical Cancer   Ovarian Cancer   Prostate Cancer   Soft Tissue Sarcoma   Vaginal Cancer   Vulvar Cancer  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Radiogenomics: Assessment of Polymorphisms for Predicting the Effects of Radiotherapy (RAPPER)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   2200
Study Start Date:   March 2006
Estimated Primary Completion Date:   February 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601406

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

Sponsors and Collaborators
Christie Hospital

Investigators
Study Chair:     Catherine West     Christie Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000581139, CHNT-RAPPER, EU-20798
First Received:   January 25, 2008
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00601406
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
male breast cancer  
stage I breast cancer  
stage II breast cancer  
stage I prostate cancer  
stage II prostate cancer  
stage III prostate cancer  
stage IA cervical cancer  
stage IB cervical cancer  
stage IIA cervical cancer  
stage IIB cervical cancer  
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
fallopian tube cancer
stage I vaginal cancer
stage II vaginal cancer

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Gonadal Disorders
Malignant mesenchymal tumor
Urogenital Neoplasms
Vaginal Diseases
Ovarian Diseases
Ovarian epithelial cancer
Soft tissue sarcomas
Uterine Cervical Neoplasms
Neoplasms, Connective and Soft Tissue
Endometrial Neoplasms
Uterine Cervical Diseases
Vulvar Neoplasms
Uterine Neoplasms
Endometrial cancer
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Vaginal Neoplasms

Additional relevant MeSH terms:
Genital Diseases, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Endocrine System Diseases
Genital Diseases, Male
Adnexal Diseases

ClinicalTrials.gov processed this record on July 03, 2008




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