Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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 augustus 2013 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

2200

Fase

Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
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

Secundaire uitkomstmaten

Uitkomstmaat
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Christie NHS Foundation Trust

Onderzoekers

Studie stoel: Catherine West, The Christie NHS Foundation Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2006

Primaire voltooiing (Verwacht)

1 februari 2008

Studieregistratiedata

Eerst ingediend

25 januari 2008

Eerst ingediend dat voldeed aan de QC-criteria