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A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer

NCT02888366 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2018-10-29

No results posted yet for this study

Summary

This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined with breast test results improves clinical sensitivity and specificity in a group that has an increased prior probability of cancer. Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).

Conditions

Sponsors & Collaborators

  • University of Southern California

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Hackensack Meridian Health

    collaborator OTHER

  • St. Michael's Medical Center

    collaborator UNKNOWN

  • Menssana Research, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Phillips, MD · Menssana Research, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02888366 on ClinicalTrials.gov