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Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study

N

Namida Lab

Status

Invitation-only

Conditions

Breast Cancer
Melanoma
Ovarian Cancer
Prostate Cancer
Pancreatic Cancer

Treatments

Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT05223218
IRB#56402

Details and patient eligibility

About

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.

Full description

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-100 years of age
  • 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

  • Less than 18 years of age OR more than 100 years of age
  • Concurrent eye infection or trauma
  • Acute conjunctivitis

Trial design

500 participants in 6 patient groups

Breast Cancer
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Pancreatic Cancer
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Colon Cancer
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Prostate Cancer
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Melanoma
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.
Healthy Control
Description:
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.
Treatment:
Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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