Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database

NCT01937052 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 329

Last updated 2024-12-13

No results posted yet for this study

Summary

The purpose of this project is to establish a repository of information and samples from breast cancer patients or those at high risk of developing breast cancer, who are initiating hormone therapy as part of standard clinical care or prevention. This repository will include patient reported outcomes and other questionnaires, information on medication use, data about adherence to the hormone therapy and tumor characteristics, including prospectively collected samples.

Conditions

Interventions

OTHER

Sample collection

Participants will be offered the option to consent for blood (preferred) or saliva for DNA pharmacogenetic testing, and for additional samples for banking for future studies.

BEHAVIORAL

Patient-reported outcomes

Patient reported outcomes (PROs) will be collected via electronic questionnaires that will be administered to patients at regular intervals per the study calendar; in most cases, this should coincide with medical oncology follow-up.

Sponsors & Collaborators

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Vered Stearns, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-09
Primary Completion
2022-01-03
Completion
2024-11-25

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01937052 on ClinicalTrials.gov