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Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer

10. juli 2018 opdateret af: Erin Cobain, University of Michigan

Through the investigators' Breast Care Center at the University of Michigan Comprehensive Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant chemotherapy. The majority of the remainder of patients with stage II and III disease undergo treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care. There is a subset of women with ER positive disease who do not receive chemotherapy because of favorable tumor characteristics.

This tissue procurement protocol is designed to systematically collect tissue, urine and blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy, serially following treatment, and/or at the time of disease recurrence in order to investigate mechanisms underlying development of metastatic disease, to identify predictors of response and resistance to therapy, and to test potential new therapies for breast cancer using a combination of patient-derived xenograft creation and new microfluidic technologies.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

14

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Comprehensive Cancer Center

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

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients who present with newly diagnosed breast cancer or breast cancer recurrence.

Beskrivelse

Entry Criteria for patients receiving neoadjuvant or adjuvant therapy (groups 1 and 2)

Inclusion Criteria

  • All patients must have a primary invasive breast cancer with the primary tumor intact (T2-4, any N, any M). Inflammatory breast cancer is permitted.
  • For the neoadjuvant cohort (group 1), the patient's clinical plan includes neoadjuvant systemic therapy (chemotherapy, hormonal therapy, and/or biologic therapy) prior to surgery on the breast.
  • For the adjuvant cohort (group 2), the patient's clinical plan includes surgical resection of the primary breast mass followed by adjuvant chemotherapy (with or without endocrine therapy or biologic therapy such as trastuzumab).
  • Patients in the neoadjuvant cohort must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
  • All patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan IRB standards.

Exclusion Criteria - For the neoadjuvant cohort (group 1): Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave at least 2 cm of measurable disease by physical examination, mammography, or ultrasound (with the exception of inflammatory breast cancer)

- For the adjuvant cohort (group 2): Tumors diagnosed by excisional or incisional biopsy and which are not likely to have at least 2 cm of residual tumor remaining

  • Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
  • Patients with another active systemic malignancy within the past year.

Entry Criteria for patients with newly diagnosed locoregional or distant disease recurrence (who did not enroll at the time of initial adjuvant or neoadjuvant chemotherapy) (group 3)

Inclusion Criteria

  • Patients must have been previously diagnosed with non-invasive or invasive breast cancer.
  • Patients must have been diagnosed with biopsy-proven recurrence of breast cancer at any site
  • All patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan IRB standards.

Exclusion Criteria

  • Patients must not have received any chemotherapy, hormonal therapy, or radiation therapy for treatment of their recurrent breast cancer.
  • Patients must not have been diagnosed with another active systemic malignancy within the past year.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Neoadjuvant
Patients initiating standard of care treatment with primary systemic therapy for breast cancer
Adjuvant
Patients initiating standard of care treatment with surgery followed by adjuvant chemotherapy for breast cancer
Recurrence
Patients with a history of breast cancer who are diagnosed with disease recurrence

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Collection of samples for analysis of somatic mutations
Tidsramme: 5 years
Mutations in the tumor before and after primary systemic therapy will be examined
5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Collection of samples for analysis of circulating biomarkers
Tidsramme: 5 years
Change in circulating biomarkers, including extracellular DNA and RNA, over time will be examined
5 years

Samarbejdspartnere og efterforskere

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

Sponsor

University of Michigan

Efterforskere

  • Ledende efterforsker: Erin F Cobain, MD, University of Michigan

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 (Faktiske)

30. maj 2014

Primær færdiggørelse (Faktiske)

7. april 2017

Studieafslutning (Faktiske)

7. april 2017

Datoer for studieregistrering

Først indsendt

26. maj 2015

Først indsendt, der opfyldte QC-kriterier

27. maj 2015

Først opslået (Skøn)

28. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2018

Sidst verificeret

1. juli 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00084633

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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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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