NCT02712645

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

March 15, 2016

Last Update Submit

April 4, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of patients with untreated newly diagnosed breast cancer.

    1 Year

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women scheduled for a breast biopsy.

You may qualify if:

  • Females of all racial and ethnic groups who are 40 years or older.
  • Women must:
  • 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
  • be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Redding, California, United States

RECRUITING

Unknown Facility

Dallas, Texas, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Storm Stillman

CONTACT

clinical@luminist.io

Will Olsen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

US(2)