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Trial record 74 of 557 for:    Genetic AND family history

Combined Breast Cancer Risk Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03067389
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
A prospective, non-interventional study in women 18 to 84 years of age. Subjects will provide a sample for genetic testing and information about their medical and family history. The results of the genetic test will be combined with clinical data to validate a method of predicting breast cancer risk.

Condition or disease Intervention/treatment
Hereditary Cancer Diagnostic Test: Diagnostic test

Detailed Description:
This is a prospective, non- interventional study. Women presenting at imaging centers for routine breast cancer screening or breast cancer diagnostic assessment and who provide written informed consent will undergo genetic testing. Subjects will also provide information about their personal medical and cancer history and family cancer history. The results of the genetic test will be combined with the subject's clinical information, family history, and a risk assessment model to validate a new method of predicting breast cancer.

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Study Type : Observational
Actual Enrollment : 553 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of a Combined Breast Cancer Risk Derived From a Polygenic Risk Score and the Tyrer-Cuzick Model
Actual Study Start Date : February 6, 2016
Actual Primary Completion Date : January 8, 2019
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
History of invasive breast cancer
Subjects with a diagnosis of invasive breast cancer within the past 12 months will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.
Diagnostic Test: Diagnostic test
Genetic diagnostic test

No history of invasive breast cancer
Subjects with no history of breast cancer will provide a blood or saliva sample for genetic diagnostic testing and provide information about their personal medical and cancer history and family cancer history.
Diagnostic Test: Diagnostic test
Genetic diagnostic test




Primary Outcome Measures :
  1. To demonstrate that a combined breast cancer risk derived from a polygenic risk score and a breast cancer risk assessment model is a better predictor of breast cancer than the risk assessment model alone [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. To derive a distribution of polygenic risk scores in an unselected patient population [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
Whole blood and saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women presenting at imaging centers for a breast cancer diagnostic assessment visit or preventative screening visit.
Criteria

Inclusion Criteria:

Women without breast cancer:

  • 18 to 84 years of age
  • Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
  • No history of invasive breast cancer

Women with a history of breast cancer:

  • 18 to 84 years of age
  • Western/Northern European, Central/Eastern European, or Ashkenazi ancestry
  • Pathologically confirmed invasive breast cancer diagnosed within the past 12 months

Exclusion Criteria:

  • Unwilling to provide written informed consent
  • Women with history of ductal carcinoma in situ (DCIS).
  • Patient has had a prior breast biopsy, exclusive of a breast biopsy diagnostic of breast cancer, that showed either hyperplasia, atypical hyperplasia, lobular carcinoma in situ (LCIS), or the specific histologic result is unknown to the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067389


Locations
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United States, Arkansas
The Breast Center of Northwest Arkansas
Fayetteville, Arkansas, United States, 72703
United States, Florida
Bethesda Health
Boynton Beach, Florida, United States, 33437
United States, Massachusetts
Cuda Women's Health Center
Hyannis, Massachusetts, United States, 02601
United States, New York
Elizabeth Wende Breast Care
Rochester, New York, United States, 14620
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
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Study Director: John Holmsn, MD Myriad Genetics, Inc.

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03067389     History of Changes
Other Study ID Numbers: HCP-018
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No