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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. august 2013 oppdatert 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

2200

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
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

Sekundære resultatmål

Resultatmål
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Christie NHS Foundation Trust

Etterforskere

Studiestol: Catherine West, The Christie NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2006

Primær fullføring (Forventet)

1. februar 2008

Datoer for studieregistrering

Først innsendt

25. januar 2008

Først innsendt som oppfylte QC-kriteriene