NCT02888366

Brief 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™).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 22, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

August 22, 2016

Last Update Submit

October 25, 2018

Conditions

Breast Cancer

Keywords

breast cancerbreath testMenssanaAncillaryMammographyRapid Point-of-careInflatable Bag

Outcome Measures

Primary Outcomes (1)

  • A PROSPECTIVE VALIDATION STUDY OF A RAPID POINT-OF-CARE BREATH TEST FOR BREAST CANCER

    Change in sensitivity and specificity of mammography for breast cancer when combined with results of breath test.

    2 years

Study Arms (1)

1

Breath samples taken, no treatment given.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

2,000 women undergoing diagnostic mammography for breast-related symptoms or signs.

You may qualify if:

  • Female aged 18 years or over
  • Referred for mammography for a breast-related concern (e.g. breast mass, nipple discharge etc.)
  • Understands the study, and is willing to give written informed consent to participate
  • Approves collection of relevant additional data for clinical research record if and when it becomes available, including results of mammogram and any other imaging studies, biopsy results, TNM staging, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-)

You may not qualify if:

  • Known serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  • Previous history of treated breast cancer, or cancer of any other site, with the exception of basal cell carcinoma of skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Southern California

Los Angeles, California, 90033, United States

Location

Hackensack Medical Center, Mountainside Hospital

Montclair, New Jersey, 07042, United States

Location

St. Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Phillips, MD

    Menssana Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 5, 2016

Study Start

March 1, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

US(4)