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| Name | Class |
|---|---|
| The University of Texas Medical Branch, Galveston | OTHER |
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This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women recently diagnosed with breast cancer who have not undergone any treatment. | Tear sample collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Schirmer Strip | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Klimberg, MD, PhD | UTMB Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTMB Health | Galveston | Texas | 77555-0737 | United States |
IPD will not be shared or made available to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2021 | Jul 6, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2021 | Jul 6, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Lacrimal (tear) fluid
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |