Breast Cancer ScreeningNCT05268224
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
An observational study of Breast Cancer Screening, run by Namida Lab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Schirmer Strip
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have been mammographically catagorized as having heterogenously dense or extremely dense breast tissue.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Namida Lab
Fayetteville, Arkansas, 72703
Anna Daily, PhD, 479-334-2828, anna@namidalab.com
About this study
Official title: 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.
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.
- Conditions
- Breast Cancer Screening
- Being tested
- Schirmer Strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer StripDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Dense Breast | Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue. Receives: Diagnostic Test: Schirmer Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Measure
Degree of closeness of categorization by a tear-based biological test scores to imaging techniques
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Oct 2021
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namida Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268224
- Sponsor's protocol ID
- IRB#2022-0073
- Status last verified
- Dec 2023
- First submitted
- 24 Feb 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not intended to be shared with other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05268224
- Acronym / sponsor ID
- IRB#2022-0073
- Conditions
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Namida LabIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dense Breast | – | Diagnostic Test: Schirmer StripWomen mammographically categorized as having either heterogeneously dense or extremely dense breast tissue. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have been mammographically catagorized as having heterogenously dense or extremely dense breast tissue.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schirmer StripA 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. | Diagnostic test | Dense Breast |
Primary outcome
Accuracy Measure
Time frame: 3 months
Degree of closeness of categorization by a tear-based biological test scores to imaging techniques
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No. Individual participant data is not intended to be shared with other researchers at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Screening, run by Namida Lab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Daily, PhD (4793342831, anna@namidalab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Measure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.