NCT00582803

Completed

Adherence to Intensive Surveillance for Hereditary Breast Ca...

Memorial Sloan Kettering Cancer Center Source

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Other study identifiers

Sponsor study identifier

03-059

Study Type

observational

Estimated enrollment

85

Locations

1 country

Sites

1

Timeline

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2009

Actual (reported)

Study Completion

March 2009

Actual (reported)

Brief Summary

Women with strong family histories of breast cancer are at increased risk to have breast cancer. Women whose close relatives have had breast cancer often have more breast cancer screening than other women their age. To increase the chance that any breast cancer will be caught early, women at risk often take part in special screening programs. These programs involve more frequent visits to the doctor for breast exams, yearly mammography, and new types of exam like breast Magnetic Resonance Imaging (MRI). Studies are going on to find out whether these programs are better than standard screening. The purpose of this study is to find out how these programs impact women's quality of life. The study will also try to learn what factors make it hard to take part in the programs. We hope to be able to design new programs that are easier to follow.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 85 participants
Study completion date: March 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
May 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 21, 2007
Actual (reported)
First Posted
December 28, 2007
Actual (reported)
Primary Completion
March 2009
Actual (reported)
Study Completion
March 2009
Actual (reported)

Last Updated: July 10, 2009
Status Verified: July 2009
Last Update Submitted: July 9, 2009

Conditions

Breast Cancer

Keywords

breast cancergermline mutationBRCA1BRCA2family historygenetic testingunaffected women over age 25 who are at elevated risk forbreast cancer by virtue by a hereditary predisposition

Outcome Measures

Primary Outcomes (1)

cognitive-affective mediating units that are likely to be involved in health information processing and the execution of health-protective behavior
5 years 7 months

Eligibility Criteria

Age25 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

unaffected women over age 25 who are at elevated risk for breast cancer by virtue by a hereditary predisposition

You may qualify if:

Female

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead
American Cancer Society, Inc.
Othercollaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Mark Robson, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

May 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2009

Actual (reported)

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Age 25 years or greater

Genetic predisposition as defined by one of the following:

Known BRCA1 or BRCA2 mutation (deleterious or uncertain significance) OR

Untested first-degree relative of an individual with a known deleterious BRCA mutation OR

Unaffected first-degree relative of an affected individual within a hereditary breast-ovarian kindred in which no testing has been performed or testing is negative, defined as: 3 or more women in 2 generations affected with breast or ovarian cancer. Women with bilateral breast cancer and woman with both breast and ovarian cancer count as single individual AND 1 woman must be first-degree relative of the other two, or related to the other two through a male AND At least 1 woman affected with breast cancer before age 50 or ovarian cancer at any age

Able to understand and complete English-language questionnaires

Intend to receive clinical and radiographic follow-up at MSKCC

Women will not be excluded if they have previously received clinical and radiographic follow-up at either MSKCC or another institution.

You may not qualify if:

Prior history of breast or ovarian cancer
Contraindication to breast MRI examination (e.g. aneurysm clips, pacemaker, cochlear implant, severe claustrophobia, weight over 300 pounds) or to paramagnetic contrast (prior IgE-type allergic reaction, sickle cell anemia, renal failure)
Pregnant or planning to begin attempts at conception within 1 year of enrollment. A negative serum β-hCG will not be required for study entry, nor for radiographic examination, as this test is not routinely performed before clinically indicated radiographic study.
Unable for physical, psychological, or financial reasons to receive clinical and radiographic follow-up at MSKCC
Concurrent medical or psychological conditions that, in the opinion of the attending physician or Principal Investigator, would place the subject at risk were she to participate

Contact the study team to confirm eligibility.

Study Completion

March 2009

Actual (reported)

Last Updated

July 10, 2009

Record last verified: 2009-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00582803
Data provider: ClinicalTrials.gov
Source updated: 2009-07-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:16 UTC

Locations

US(1)

Adherence to Intensive Surveillance for Hereditary Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations