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| Name | Class |
|---|---|
| Arkansas Urology | UNKNOWN |
| CARTI | UNKNOWN |
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This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.
The Pilot Study is an observational study to investigate the diagnostic potential of tear proteins for Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon cancer. In this pilot study, we use lacrimal gland fluid (tears) as a liquid biopsy source for investigating the protein repertoire and conducting biomarker discovery studies with a goal to develop new tear-based tests that can detect crucial cancer-related biomarkers in the pan-cancer types.
Proteomic studies on tears have shown to express between 500-1500 proteins with ~35% overlap with serum proteome. The easy accessibility of tear fluid with minimal post-processing procedures and better access to lower molecular weight proteins make tears an ideal source to identify commonly associated cancer biomarkers.
Additionally, the results from this study will aid in improving our understanding of the cancer types and commonalities that exist between them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer | Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Mammogram, ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| Pancreatic Cancer | Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| Colon Cancer | Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other | Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify Cancer-related Biomarkers | A tear protein repertoire will be created to identify key cancer biomarkers | Dec 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Protein Concentrations | The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles. | Dec 2023 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.
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| Name | Affiliation | Role |
|---|---|---|
| Prashanth Ravishankar, PhD | Namida Lab Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Namida Lab | Fayetteville | Arkansas | 72703 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Lacrimal tear fluids will be stored for conducting pr
| Prostate Cancer |
Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| Melanoma | Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| Healthy Control | Individuals aged between 18-100 years who do not currently have a previous diagnosis of any cancer for which they are currently being treated. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |