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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 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Christie NHS Foundation Trust

Efterforskere

  • Studiestol: Catherine West, The Christie NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2006

Primær færdiggørelse (Forventet)

1. februar 2008

Datoer for studieregistrering

Først indsendt

25. januar 2008

Først indsendt, der opfyldte QC-kriterier

25. januar 2008

Først opslået (Skøn)

28. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2013

Sidst verificeret

1. april 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000581139
  • CHNT-RAPPER
  • EU-20798

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsor / samarbejdspartnere

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