Clinical trial · Observational
Validation of a Tear-based Screening Assay for Breast Cancer
Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms
NCT04928014CI-TRIAL-00067741unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms. This tear-based screening test was developed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | — | UNRESOLVED | — |
| Health Care Acceptability | — | UNRESOLVED | — |
| Health Care Utilization | — | UNRESOLVED | — |
| Health Knowledge, Attitudes, Practice | — | UNRESOLVED | — |
| Health Personnel Attitude | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Schirmer Strip | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening Mammogram
- description
- Individuals eligible for a screening mammogram.
- interventionNames
- Other: Schirmer Strip
Primary outcomes (1)
- measure
- Validation of a tear-based biological test
- timeFrame
- 3 years
- description
- The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the a tear-based biological test compared to results of imaging
Secondary outcomes (1)
- measure
- Defining clinical utility of a tear-based biological test
- timeFrame
- 3 years
- description
- The secondary objective of this study is to obtain provider insight and recommendation as to the potential clinical utility of a tear-based biological test as a breast cancer screening option.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures Exclusion Criteria: Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection under 18 years of age
References
Publications (0)
Data not yet available
No reference posted for this study.