A Tear-based, Lab-developed Test for Breast Cancer for Wo... | NCT05268224

Studies
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

NCT05268224

Sponsor

Namida Lab

Status

Unknown status

Last Update Posted

Dec 11, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Breast Cancer Screening

Interventions

Schirmer Strip

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Feb 24, 2022

First Posted Date

Mar 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dense Breast		Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.	Diagnostic Test: Schirmer Strip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Schirmer Strip	Diagnostic Test	A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA-certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy Measure	Degree of closeness of categorization by a tear-based biological test scores to imaging techniques	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Eligibility is based on individuals who biologically qualify to participate in yearly breast cancer screening and who have dense breast tissue.

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Women who have been mammographically catagorized as having heterogenously dense or extremely dense breast tissue.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Daily, PhD	Contact	4793342831		anna@namidalab.com
Prashanth Ravishankar, PhD	Contact	4793342828		prashanth@namidalab.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Namida Lab	Recruiting	Fayetteville	Arkansas	72703	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data is not intended to be shared with other researchers at this time.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided