Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
NCT ID: NCT05223218
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-08-25
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
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.
Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
Interventions
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Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
Eligibility Criteria
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Inclusion Criteria
* Presenting for the 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 may be pre or post-biopsy/diagnostic as long as there is a portion of the mass remaining.
* Have been diagnosed but have not received treatment
Exclusion Criteria
* Concurrent eye infection or trauma
* Acute conjunctivitis
18 Years
100 Years
ALL
Yes
Sponsors
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Arkansas Urology
UNKNOWN
CARTI
UNKNOWN
Namida Lab
INDUSTRY
Responsible Party
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Principal Investigators
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Prashanth Ravishankar, PhD
Role: PRINCIPAL_INVESTIGATOR
Namida Lab Inc
Locations
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Namida Lab
Fayetteville, Arkansas, United States
Countries
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Other Identifiers
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IRB#56402
Identifier Type: -
Identifier Source: org_study_id
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