NCT01649661

Brief Summary

The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

10.6 years

First QC Date

July 19, 2012

Last Update Submit

January 25, 2023

Conditions

Cancer Free Women

Keywords

MRI12-125premenopausal womenpostmenopausal womenquestionnaire

Outcome Measures

Primary Outcomes (1)

  • breast cancer risk factors and background parenchymal enhancement (BPE).

    A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.

    1 year

Secondary Outcomes (1)

  • relationship between BPE and serum hormone levels at the time of MRI

    1 year

Study Arms (2)

premenopausal women

Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.

Behavioral: questionnaire

postmenopausal women

Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL
Also known as: The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27, questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical, history, family history of cancer, reproductive history, use of hormonal medications, alcohol and, smoking, contact information/comments.
postmenopausal womenpremenopausal women

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.

You may qualify if:

  • age 21 years or older
  • be a cancer-free pre- or postmenopausal woman
  • have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer)
  • able to speak and read English because the questionnaire is only available in English
  • able to provide informed consent

You may not qualify if:

  • are pregnant at the time of MRI
  • have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample collected at time of MRI for serum hormone analysis Postmenopausal women only

MeSH Terms

Interventions

Surveys and QuestionnairesHealth Records, PersonalReproductive HistoryEthanolSmoking Devices

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMedical RecordsRecordsMedical History TakingDiagnostic Techniques and ProceduresDiagnosisEpidemiologic FactorsAlcoholsOrganic ChemicalsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Janice Sung, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 25, 2012

Study Start

July 1, 2012

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

US(1)