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A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer (ONCOTYPEDX)

26. marts 2014 opdateret af: Ontario Clinical Oncology Group (OCOG)
A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC). There is only one small published prospective study that reports on Oncotype DX® changing clinical management. The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors >1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%. (The benefit comes from one trial and is applied to all patients). It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1011

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Simcoe Muskoka Cancer Program - Royal Victoria Hospital
      • Belleville, Ontario, Canada, K8N 5A9
        • Quinte Healthcare Corporation
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Centre
      • Brantford, Ontario, Canada, N3R 1G9
        • Brantford General Hospital
      • Burlington, Ontario, Canada, L7S 1W7
        • Joseph Brant Hospital
      • Cambridge, Ontario, Canada, N1R 3G2
        • Cambridge Memorial Hospital
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston
      • Kitchener, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Centre
      • Markham, Ontario, Canada, L6B 1A1
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5M 2N1
        • The Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional Cancer Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • R.S. McLaughlin Durham Regional Cancer Centre - Lakeridge Health
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Regional Cancer Centre
      • Owen Sound, Ontario, Canada, N4K 6M9
        • Grey Bruce Health Services
      • Peterborough, Ontario, Canada, K9J 7C6
        • Peterborough Regional Health Centre
      • Richmond Hill, Ontario, Canada, L4C 4Z3
        • Mackenzie Health
      • Sarnia, Ontario, Canada, N7T 6S3
        • Bluewater Health
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program - Sault Area Hospital
      • Scarborough, Ontario, Canada, M1P 2T7
        • The Scarborough Hospital
      • Scarborough, Ontario, Canada, M1E 5E9
        • Rouge Valley Health System
      • St. Catharines, Ontario, Canada, L2R 7C6
        • Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeast Cancer Centre of Health Sciences North - Horizon Sante-Nord
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences - Odette Cancer Centre
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Healthcare
      • Toronto, Ontario, Canada, M9C 1A5
        • Trillium Health Centre
      • Toronto, Ontario, Canada, M9N 1N8
        • Humber River Regional Cancer Centre
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
  • Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.

  • Axillary lymph nodes assessed for tumor by:

    (i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both

  • Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer <2mm by H&E stain).
  • Tumor is estrogen receptor (ER) positive.
  • Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
  • Being considered for adjuvant chemotherapy.

Exclusion Criteria:

  • Axillary lymph node positive for cancer.
  • Patients with inoperable locally advanced breast cancer.
  • Metastatic breast cancer, including local ipsilateral recurrence.
  • HER2 neu positive.
  • Physician/Patient unwilling to comply with study protocol.
  • Inability to provide informed consent (e.g. dementia or severe cognitive impairment).

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Early Stage Breast Cancer
Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
Genetisk: ONCOTYPEDX Test
Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in treatment recommendation
Tidsramme: One month
The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
One month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between Oncotype DX® RS with other estimated risk calculations
Tidsramme: One month
The level of association between the Oncotype DX® RS with estimated recurrence risk calculated by Adjuvant! Online, as well as with traditional factors including tumor size, grade, and HER2 neu.
One month
Change in patient decisional conflict
Tidsramme: One month
The change in the level of patient decisional conflict measured by the Decisional Conflict Scale (DCS). Additionally, the DCS has three subscales: uncertainty, effective decision making, and factors contributing to uncertainty. The change in each of these subscales will also be measured.
One month
Robustness of economic model of sequential Adjuvant! Online followed by Oncotype DX®.
Tidsramme: 6 months
To determine the robustness of the economic model of sequential Adjuvant! Online followed by Oncotype DX®.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Ontario Clinical Oncology Group (OCOG)

Samarbejdspartnere

Ontario Ministry of Health and Long Term Care

Efterforskere

  • Ledende efterforsker: Mark N. Levine, MD, Ontario Clinical Oncology Group (OCOG)

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. januar 2012

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

24. august 2011

Først indsendt, der opfyldte QC-kriterier

24. august 2011

Først opslået (Skøn)

26. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OCOG-2011-ONCOTYPEDX

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 .

Kliniske forsøg med Brystkræft

Kliniske forsøg med ONCOTYPEDX Test

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner