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Brystmammografi og vævsundersøgelse

15. oktober 2026 opdateret af: National Cancer Institute (NCI)

Brystradiologievaluering og undersøgelse af væv (bryststempelprojekt).

Background:

Women whose mammograms show a lot of dense areas are more likely to develop breast cancer and to have cancers that are missed by mammograms.

It is unclear why some factors lead to having dense breasts and why having dense breasts increases the risk of developing breast cancer.

Objectives:

To determine why some women s breasts look dense on mammograms.

To determine what types of cells and tissues make up dense areas of breasts and why these tissues may be more likely to become cancerous.

Eligibility:

Women between 40 and 65 years of age who have not had breast cancer or received medicines or radiation for any type of cancer and who are scheduled to undergo a breast biopsy.

Design:

This study is conducted at the University of Vermont, in collaboration with the NCI.

Participants undergo the following:

  • Review of their medical records collected over the last 2 years by the Vermont Mammography Registry.
  • Participation in a short telephone interview.
  • Height and weight measurement.
  • Testing of biopsy tissue collected for diagnosis or treatment.
  • Future contacts regarding health status for up to 10 years, including review of additional mammograms, removed tissues, questionnaires and medical records collected by the Vermont Mammography Registry during the 10-year study.

Participants may also undergo the following optional procedures:

  • Provide a mouthwash sample for genetic testing.
  • Provide a blood sample to test for markers of dense mammograms or breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

High breast density and aging are the strongest risk factors for sporadic breast cancer among women. Although glandular epithelium contributes to mammographic density, non-epithelial tissue components represent its major determinants: adipose tissue is radiolucent and fibrous tissue is dense. The hypothesis is that epidemiologic factors associated with elevated breast density alter the breast microenvironment (ME) (defined as all cells and structures surrounding luminal glandular cells including: myoepithelial cells; basement membrane, stromal fibroblast and myofibroblasts; endothelial cells and pericytes; inflammatory cells, collagens, matrix proteins, growth factors, hormones, and other biochemical components) in a manner that enhances dysregulated proliferation of breast epithelium and ultimately cancer. Specifically, the Investigators propose that epidemiologic factors that lead to increased exposure to hormones and inflammatory mediators alter the ME, leading to both increased breast density and cancer. The critical importance of the ME in carcinogenesis is supported by experimental and clinical data showing that epithelial abnormalities alone are generally insufficient for cancer development without concurrent changes in the ME. The primary aim of this pilot study is to demonstrate the feasibility of collecting the data needed to elucidate the biologic mechanisms that mediate the substantial breast cancer risk associated with high mammographic density. Specifically, the Investigators will develop, fine tune, and validate a complex cross-sectional study protocol to collect risk factor data and biological specimens (blood, buccal cells, tissue fluids, and tissue) required to discover mechanisms and biomarkers that link high mammographic density (as measured quantitatively using computerized methods) to breast cancer risk. They will enroll 250 women between the ages of 40 to 65 years undergoing a radiologically guided biopsy at the University of Vermont, the largest center within the Vermont Breast Cancer Surveillance System (VBCSS), to participate in this pilot study of mammographic density.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

466

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05405
        • University of Vermont

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

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Primary clinical- patients referred to diagnostic breast biopsy due to an abnormal breast imaging exam.

Beskrivelse

  • INCLUSION CRITERIA:

Inclusion criteria for participation in the study are women, ages 40-65 years of age, who are undergoing a radiologically-guided biopsy (stereotactic- ultrasound-guided). We will NOT exclude subjects for current or past use of exogenous hormones; prior hysterectomy or salpingoophorectomy or presentation with a breast mass. Although most biopsies are prompted by a radiologic finding (typically abnormal calcifications or masses), some biopsies are performed for symptoms that are unassociated with a radiologic finding, such as nipple discharge, palpable mass, discomfort, etc. Elevated density per se is not a biopsy indication. ALL women referred for radiologically guided biopsy, irrespective of the indication, will be considered eligible for the pilot study.

EXCLUSION CRITERIA:

We will EXCLUDE women who have a prior history of breast cancer, have had an EXCISIONAL breast biopsy within one year, women who have implants in place, women taking tamoxifen or raloxifene for chemoprevention and women who have received non-surgical treatments for cancers of other organs.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Breast Cohort

Primary clinical- patients referred to diagnostic breast biopsy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of collecting data needed
Tidsramme: Dec. 2022

Feasibility of collecting data needed from pilot to report the preliminary results from the pilot data in published manuscripts.
Dec. 2022

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Gretchen L Benson, Ph.D., National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

11. maj 2007

Datoer for studieregistrering

Først indsendt

18. maj 2007

Først indsendt, der opfyldte QC-kriterier

18. maj 2007

Først opslået (Anslået)

21. maj 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2026

Sidst verificeret

30. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 999907150
  • 07-C-N150

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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