ACTIVE_NOT_RECRUITING

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. The clinical Investigators or a member of their staff will conduct consent discussion once a suspicious mammogram report is identified or if a patient is referred for imaging of a suspicious area in the breast. After consenting the participant will be asked to donate a blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report and a medical history questionnaire. The participants will be followed after one year to capture progression or resolution of their suspicious mammogram report. After a biopsy confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be requested for research.

Official Title

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Quick Facts

Study Start:2017-05-08
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03147430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women who receive a suspicious mammogram report or are scheduled to receive testing for suspect breast area, with a subsequent biopsy to confirm diagnosis
  2. * Willingness and ability to donate biospecimens for the purpose of propelling research.
  3. * Participants aged ≥ 18.
  1. * Individuals under 18 years of age or over 89 years of age.
  2. * A known history of breast cancer.
  3. * A diagnosis or history of any other type of cancer.
  4. * Participants who are male.

Contacts and Locations

Principal Investigator

Richard Hoefer, DO
PRINCIPAL_INVESTIGATOR
Sentara Healthcare

Study Locations (Sites)

Dorothy G Hoefer Comprehensive Breast Center
Newport News, Virginia, 23606
United States
Sentara Norfolk General Breast Center
Norfolk, Virginia, 23507
United States

Collaborators and Investigators

Sponsor: Sentara Norfolk General Hospital

  • Richard Hoefer, DO, PRINCIPAL_INVESTIGATOR, Sentara Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-08
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-05-08
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer