HealthyNCT04928014
Validation of a Tear-based Screening Assay for Breast Cancer
An observational study of Healthy and Breast Cancer, run by Namida Lab at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Breast Cancer, Breast Cancer Female
- What is being tested?
- Schirmer Strip
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to Dec 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be primarily women over the age of 35 who participate in yearly screening mammography. There are instances where a screening mammogram is given under the age of 35, therefore the enrollment age has been set at 18 years of age or older. Participants will be recruited from participating clinical sites which would include breast radiology speciality clinics, OB/GYN practice, internal medicine clinics, and primary care clinics.
Who may be able to join
- Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures
Who cannot join
- Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms
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.
Read the detailed description
The primary objective of this study is to determine if a tear-based biological test is an effective option in breast cancer screening. This will be assessed by comparing the score and classification produced from the assay to the current gold standard, screening Mammograms.
The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the biological assay compared to the results of imaging.
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.
The secondary endpoint will be achieved through a provider roundtable discussion. After completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the test scores determined for the sites patient population. Providers will be allowed to verbally review the process and give their thoughts on the utility of a tear-based biological test within their clinic and how they feel it should be used. A member of the Namida Lab clinical team will be present to take notes. After the discussion a report will be generated and the site providers will be allowed to review it for accuracy. Sites will be given a copy of their participants' scores as well as a summary of the provider roundtable discussion. Sites may request to have the participants' results blinded if prior to review if preferred.
- Conditions
- Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization, Health Knowledge, Attitudes, Practice, Health Personnel Attitude
- Being tested
- Schirmer Strip
- Keywords
- preventative screening, protein biomarkers, lacrimal tear fluid, mammography, primary care, ELISA assay, CLIA laboratory, lab developed test, clinical utility, high complexity, underserved populations, health disparities, tear collection, mammogram, improved patient outcomes, reduces gap in access, health equity, total cost of care, trust from patient, increased compliance
- Medical subject headings
- Breast Neoplasms, Patient Acceptance of Health Care, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer StripOther
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 |
|---|---|---|
| Screening Mammogram | Individuals eligible for a screening mammogram. Receives: Other: Schirmer Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a tear-based biological test
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
Measured: 3 years
Secondary outcomes (1)
Defining clinical utility of a tear-based biological test
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start1 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 205 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
- NCT04928014
- Sponsor's protocol ID
- Namida_001
- Other IDs
- PRO00053749
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Tear-based Screening Assay for Breast Cancer as a Supplemental Tool to Screening Mammograms
- ClinicalTrials.gov ID
- NCT04928014
- Acronym / sponsor ID
- Namida_001
- Conditions
- Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization, Health Knowledge, Attitudes, Practice, Health Personnel Attitude
- Keywords
- preventative screening, protein biomarkers, lacrimal tear fluid, mammography, primary care, ELISA assay, CLIA laboratory, lab developed test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Namida LabIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Jun 2021 (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.
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.
Detailed description
The primary objective of this study is to determine if a tear-based biological test is an effective option in breast cancer screening. This will be assessed by comparing the score and classification produced from the assay to the current gold standard, screening Mammograms.
The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for the biological assay compared to the results of imaging.
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.
The secondary endpoint will be achieved through a provider roundtable discussion. After completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the test scores determined for the sites patient population. Providers will be allowed to verbally review the process and give their thoughts on the utility of a tear-based biological test within their clinic and how they feel it should be used. A member of the Namida Lab clinical team will be present to take notes. After the discussion a report will be generated and the site providers will be allowed to review it for accuracy. Sites will be given a copy of their participants' scores as well as a summary of the provider roundtable discussion. Sites may request to have the participants' results blinded if prior to review if preferred.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening Mammogram | – | Other: Schirmer StripIndividuals eligible for a screening mammogram. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be primarily women over the age of 35 who participate in yearly screening mammography. There are instances where a screening mammogram is given under the age of 35, therefore the enrollment age has been set at 18 years of age or older. Participants will be recruited from participating clinical sites which would include breast radiology speciality clinics, OB/GYN practice, internal medicine clinics, and primary care clinics.
Key inclusion criteria (1 listed)
- Female over the age of 18 Able to undergo the informed consent process Willingness to comply with all study procedures
Key exclusion criteria (1 listed)
- Currently diagnosed or are receiving treatment for breast cancer Have an active eye infection 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. | Other | Screening Mammogram |
Primary outcome
Validation of a tear-based biological test
Time frame: 3 years
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
1 secondary outcome
Defining clinical utility of a tear-based biological test
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy and Breast Cancer, 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 3 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a tear-based biological test (time frame: 3 years). 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 3 Jul 2023.