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Studying Blood and Tumor Tissue Samples in Women With Invasive Breast Cancer, Ductal or Lobular Carcinoma in Situ, or Benign Breast Disease

23. december 2019 opdateret af: City of Hope Medical Center

Blood Tumor Markers for Molecular Diagnosis of Breast Diseases and Monitoring of Breast Cancer Treatment and Follow-up

RATIONALE: Collecting and storing samples of blood and tumor tissue from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This clinical trial is studying blood and tumor tissue samples in women with invasive breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or benign breast disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • To establish a specimen bank from peripheral blood specimens collected from women with a full spectrum of breast disease (invasive breast cancer [IBC], ductal or lobular carcinoma in situ [CIS], or benign breast disease [BBD]) with standardized clinical follow up and serial specimen collection for those with IBC.
  • To determine the ability of quantitative real-time reverse-transcriptase PCR (qRT-PCR) to discriminate between patients with IBC, CIS, and BBD by comparing baseline assay values from pre-biopsy specimens to the histologic diagnosis.
  • To determine the ability of qRT-PCR to predict treatment response by comparing serial assay values from patients with evaluable IBC to their objective response.
  • To determine the ability of qRT-PCR to predict relapse by comparing the serial assay values from all patients with IBC to their disease status.
  • To determine the ability of qRT-PCR to perform as an independent prognostic factor by comparing baseline assay values from all patients with IBC to their disease status, stratified by known breast cancer prognostic factors.

Secondary

  • To perform exploratory studies identifying potential targets for novel nucleic acid and proteomic-based early detection assays.

OUTLINE: Patients undergo baseline peripheral blood specimen collection pre-biopsy and then periodically for up to 10 years. Specimens are analyzed for circulating tumor cells via quantitative real-time reverse-transcriptase PCR, immunofluorescence, and bidirectional pyrophosphorolysis-activated polymerization allele-specific amplification; and for protein profiles via mass spectometry, liquid chromatography, enzyme digestion, and tandem mass spectometry. Patients' tumor tissue (invasive breast cancer [IBC] only) is analyzed for p53 via IHC. Medical records are reviewed periodically.

Patients with IBC complete a quality of life assessment at baseline and every 6 months for up to 10 years.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

563

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Tower Cancer Research Foundation
      • Duarte, California, Forenede Stater, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Pasadena, California, Forenede Stater, 91105
        • City of Hope Medical Group

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

City of Hope New patients

Beskrivelse

DISEASE CHARACTERISTICS:

  • Biopsy-confirmed diagnosis of one of the following:

    • Stage I-IV infiltrating ductal or infiltrating lobular carcinoma

      • Patients with early-stage disease must not have started systemic treatment; if no systemic treatment is planned, patients must be either preoperative or ≤ 120 days since definitive breast surgery
      • Patients with locally advanced disease must be scheduled for neoadjuvant chemotherapy prior to initiation of systemic treatment
    • Ductal carcinoma in situ
    • Lobular carcinoma in situ

    • Benign breast disease

      • Proliferative or non-proliferative
      • With or without atypia

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 50-100%
  • Not pregnant
  • No prior invasive cancer diagnosis within the past 5 years except for squamous cell or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic therapy (chemotherapy or hormonal therapy) for patients with stage I-III disease

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Normal benign breast disease or ductal carcinoma in situ
Genetisk: genekspressionsanalyse
Andet: medicinsk diagram gennemgang
Andet: laboratoriebiomarkøranalyse
Genetisk: mutationsanalyse
Genetisk: proteomisk profilering
Andet: massespektrometri
Genetisk: omvendt transkriptase-polymerase kædereaktion
Procedure: livskvalitetsvurdering
Andet: immunhistokemi farvningsmetode
Andet: fluorescerende antistof teknik
Andet: væskekromatografi
Invasive breast cancer
Genetisk: genekspressionsanalyse
Andet: medicinsk diagram gennemgang
Andet: laboratoriebiomarkøranalyse
Genetisk: mutationsanalyse
Genetisk: proteomisk profilering
Andet: massespektrometri
Genetisk: omvendt transkriptase-polymerase kædereaktion
Procedure: livskvalitetsvurdering
Andet: fluorescerende antistof teknik
Andet: væskekromatografi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Establishment of a specimen bank
Tidsramme: 5 Years of specimen collection
5 Years of specimen collection
Ability of the quantitative real-time reverse-transcriptase PCR (qRT-PCR) to distinguish between biopsy benign and malignant results
Tidsramme: 5 years
5 years
Ability of the qRT-PCR to predict treatment response
Tidsramme: 5 years
5 years
Ability of the qRT-PCR to predict relapse
Tidsramme: 5 years
5 years
Ability of the qRT-PCR to perform as an independent prognostic factor
Tidsramme: 5 years
5 years

Samarbejdspartnere og efterforskere

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

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Robert Hickey, Ph.D., City of Hope Comprehensive Cancer Center

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. august 2005

Primær færdiggørelse (Faktiske)

6. juni 2019

Studieafslutning (Faktiske)

6. juni 2019

Datoer for studieregistrering

Først indsendt

9. maj 2009

Først indsendt, der opfyldte QC-kriterier

9. maj 2009

Først opslået (Skøn)

12. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. december 2019

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 04125
  • P30CA033572 (U.S. NIH-bevilling/kontrakt)
  • CHNMC-04125 (Registry Identifier: NCI PDQ)
  • CDR0000628766 (Registry Identifier: NCI)

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 genekspressionsanalyse

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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