Breast CancerNCT04974567
Tear Based Sample Collection Breast Cancer Detection
An observational study of Breast Cancer and Tear, run by Namida Lab at 1 site in United States.
Trial summary
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer, Tear, Breast Cancer Female
- What is being tested?
- Schirmer Strip
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 15 Sep 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
- No healthy volunteers
- Adult, Older adult
Study population: The Tear Based Breast Cancer Detection study participants are all women, born biologically female, with a recent diagnosis of breast cancer, have not started treatment, and are between the ages of 18 to 100 years old.
Who may be able to join
- Individual is an adult woman and has recently been diagnosed with breast cancer.
Who cannot join
- Individual is excluded if they have already started treatment for the breast cancer diagnosis.
- Age less than 18 or more than 100 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tear Based Sample Collection for Breast Cancer Detection
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
Read the detailed description
Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.
- Conditions
- Breast Cancer, Tear, Breast Cancer Female
- Being tested
- Schirmer Strip
- Keywords
- preventative screening, protein biomarkers, lacrimal tear fluid, mammography, ELISA assay, CLIA laboratory, lab developed test, high complexity, tear collection, mammogram, improved patient outcomes, reduce gap in access, health equity, total cost of care, trust from patient, increased compliance, affordable, low cost, non-invasive, women's health and wellness
- Medical subject headings
- Breast Neoplasms, Lacerations
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 |
|---|---|---|
| Women recently diagnosed with breast cancer who have not undergone any treatment. | Tear sample collection Receives: Other: Schirmer Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant tear samples collected.
The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start28 Apr 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namida Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The University of Texas Medical Branch, Galveston
- Responsible party
- Sponsor
- Investigators
- Suzanne Klimberg, MD, PhD, Principal investigator, UTMB Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974567
- Sponsor's protocol ID
- IRB # 21-0026
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared or made available to other researchers.
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
- Tear Based Sample Collection for Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT04974567
- Acronym / sponsor ID
- IRB # 21-0026
- Conditions
- Breast Cancer, Tear, Breast Cancer Female
- Keywords
- preventative screening, protein biomarkers, lacrimal tear fluid, mammography, ELISA assay, CLIA laboratory, lab developed test, high complexity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Namida LabIndustry (pharma, biotech, devices)
- Collaborators
- The University of Texas Medical Branch, Galveston
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 23 Jul 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 aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
Detailed description
Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women recently diagnosed with breast cancer who have not undergone any treatment. | – | Other: Schirmer StripTear sample collection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Tear Based Breast Cancer Detection study participants are all women, born biologically female, with a recent diagnosis of breast cancer, have not started treatment, and are between the ages of 18 to 100 years old.
Key inclusion criteria (1 listed)
- Individual is an adult woman and has recently been diagnosed with breast cancer.
Key exclusion criteria (2 listed)
- Individual is excluded if they have already started treatment for the breast cancer diagnosis.
- Age less than 18 or more than 100 years.
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 | Women recently diagnosed with breast cancer who have not undergone any treatment. |
Primary outcome
Number of participant tear samples collected.
Time frame: 90 days
The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.
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. IPD will not be shared or made available to other researchers.
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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.
Suzanne Klimberg, MD, PhD principal investigator
UTMB Health
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 and Tear, 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 2 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?
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?
Number of participant tear samples collected. (time frame: 90 days). 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.