Melody®, a Lab Developed Test for Breast Cancer for Women With Dense Breast Tissue

Sponsor

Namida Lab (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05268224

Collaborator

(none)

1,500

Enrollment

Location

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigation of Melody®, a lab developed test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if Melody®, can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. Melody® was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Screening	Diagnostic Test: Melody

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigation of Melody®, a Lab Developed Test for Breast Cancer, as a Supplemental Tool to Current Screening Recommendations for Women With Dense Breast Tissue.

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Dense Breast Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.	Diagnostic Test: Melody Melody®, a new tool to assist in breast cancer screening

Arm

Intervention/Treatment

Dense Breast

Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.

Diagnostic Test: Melody

Melody®, a new tool to assist in breast cancer screening

Outcome Measures

Primary Outcome Measures

Accuracy Measure [3 months]
Degree of closeness of categorization by Melody to imaging techniques

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures

Exclusion Criteria:

Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Namida Lab	Fayetteville	Arkansas	United States	72703

Sponsors and Collaborators

Namida Lab

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Namida Lab

ClinicalTrials.gov Identifier:

NCT05268224

Other Study ID Numbers:

Melody_002

First Posted:

Mar 7, 2022

Last Update Posted:

Mar 9, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Mar 9, 2022