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A Multicenter Breast Cancer Biospecimen Registry

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: NCT02712645
Recruitment Status : Unknown
Verified April 2016 by Luminist, Inc..
Recruitment status was:  Recruiting
First Posted : March 18, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Luminist, Inc.

Study Description
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Brief Summary:
This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with untreated newly diagnosed breast cancer. [ Time Frame: 1 Year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women scheduled for a breast biopsy.
Criteria

Inclusion Criteria:

  1. Females of all racial and ethnic groups who are 40 years or older.

  2. Women must:

    1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
    2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

Exclusion Criteria:

  1. Inability to sign informed consent.
  2. More than one radiological finding.
  3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
  4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
  5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
  6. Received any experimental therapeutic treatment during the previous 3 months.
  7. Received any blood product transfusion within the previous 3 months.
  8. Use of illegal drugs during the previous 3 months.
  9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.
Contacts and Locations
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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): NCT02712645


Contacts
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Contact: Storm Stillman clinical@luminist.io
Contact: Will Olsen

Locations
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United States, California
Recruiting
Redding, California, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Sponsors and Collaborators
Luminist, Inc.
More Information
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Additional Information:

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Responsible Party: Luminist, Inc.
ClinicalTrials.gov Identifier: NCT02712645    
Other Study ID Numbers: LUM-BC-1.0
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases