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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

23 augusti 2013 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

2200

Fas

Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Behandling
Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
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

Sekundära resultatmått

Resultatmått
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The Christie NHS Foundation Trust

Utredare

Studiestol: Catherine West, The Christie NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2006

Primärt slutförande (Förväntat)

1 februari 2008

Studieregistreringsdatum

Först inskickad

25 januari 2008

Först inskickad som uppfyllde QC-kriterierna