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High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary completion date: Dec 2025 to Dec 2027

    Completion date: Dec 2026 to Dec 2027

    Study Statusv27

  2. Minor

    Study title expanded, about 4 words

    Show what changed: Study title
    High Risk Breast Clinic: Protocol for Women at Increased Risk offor Developing Breast Cancer

    Study Identification, Study Status, Sponsor/Collaborators, Study Designv26

  3. Minor

    2 amendments

    2 re-verifications since 2021-10-22, no change to tracked fields

    v24-v25

  4. Notable

    Primary completion date: Dec 2021 to Dec 2025

    Start date: Jan 1989 to Aug 1989

    Study Statusv23

  5. Notable

    Primary completion date: Dec 2020 to Dec 2021

    Completion date: Dec 2020 to Dec 2026

    Study Statusv22

Show 20 earlier versions

  1. Minor

    8 amendments

    8 re-verifications since 2014-01-08, no change to tracked fields

    v14-v21

  2. Minor

    Primary and study completion dates: Dec 2020

    Study Status, Outcome Measuresv13

  3. Notable

    Lead sponsor: University of Kansas to Carol Fabian, MD

    Study Status, Sponsor/Collaboratorsv12

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v11

  5. Minor

    Study Status, Arms and Interventions

    v10

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v9

  7. Minor

    Site contact updated

    Study Status, Arms and Interventions, Contacts/Locationsv8

  8. Minor

    Study Status, Eligibility

    Re-verified, no change to tracked fields

    v7

  9. Minor

    Study description revised

    Show what changed: Study description
    [...] ms with established risk biomarkers listed in 1, as well as werewith development of DCIS and invasive cancer. To maintain contac [...]

    Study Status, Study Descriptionv6

  10. Notable

    Enrollment target: 2000 to 3000

    Eligibility criteria revised; Study description expanded, about 5 words; Collaborators shortened, about 5 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: women with at least 2 times the normal risk of developing breast cancer between the ages of 30-5565 (or within 10 years of youngest age at diagnosis in first d [...] onths from ingestion of antihormonal therapy greater than 1 yeatyear from pregnancy, lactation, ofor chemotherapy willing to have a mammogram within six months [...]
    Show what changed: Study description
    To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol [...] etc), proteomic patterns in RPFNA and nipple aspirate fluid and (NAF), as well as NAF hormone levels, and correlate them with oth [...]
    Show what changed: Collaborators
    National Institutes of Health (NIH)

    Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Eligibilityv5

  11. Minor

    Study Status, Oversight, Study Design

    Re-verified, no change to tracked fields

    v4

  12. Notable

    Enrollment target: 500 to 2000

    Site contact updated

    Study Status, Study Design, Contacts/Locationsv3

  13. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions.
Trial Details
NCT Number NCT00291096
Lead Sponsor Carol Fabian, MD
Conditions Breast Cancer
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov