Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05223218
Status:
UNKNOWN
Last Update Posted:
2023-07-03
First Post:
2022-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Lacrimal tear fluids will be stored for conducting pr'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-29', 'studyFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2022-01-24', 'lastUpdatePostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify Cancer-related Biomarkers', 'timeFrame': 'Dec 2023', 'description': 'A tear protein repertoire will be created to identify key cancer biomarkers'}], 'secondaryOutcomes': [{'measure': 'Tear Protein Concentrations', 'timeFrame': 'Dec 2023', 'description': 'The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preventative Screening', 'Protein Biomarkers', 'Lacrimal Tear Fluid', 'Non-invasive', 'Tear Collection', 'CLIA Laboratory', 'Affordable', 'Proteomics', 'Metabolomics', 'Protein Microarray', 'ELISA assay'], 'conditions': ['Breast Cancer', 'Ovarian Cancer', 'Pancreatic Cancer', 'Prostate Cancer', 'Melanoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nProteomic 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.\n\nAdditionally, the results from this study will aid in improving our understanding of the cancer types and commonalities that exist between them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-100 years of age\n* Presenting for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)\n* Presenting for the evaluation of a palpable lump or mass\n* Presenting with a mass may be pre or post-biopsy/diagnostic as long as there is a portion of the mass remaining.\n* Have been diagnosed but have not received treatment\n\nExclusion Criteria:\n\n* Less than 18 years of age OR more than 100 years of age\n* Concurrent eye infection or trauma\n* Acute conjunctivitis'}, 'identificationModule': {'nctId': 'NCT05223218', 'briefTitle': 'Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Namida Lab'}, 'officialTitle': 'Investigating the Diagnostic Potential of Tear Proteins in Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon Cancer', 'orgStudyIdInfo': {'id': 'IRB#56402'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}, {'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}, {'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}, {'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}, {'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}, {'label': '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.\n\nLacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'interventionNames': ['Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.']}], 'interventions': [{'name': 'Schirmer strip, a Class I Medical Device typically used to test for dry eye.', 'type': 'OTHER', 'description': 'Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.', 'armGroupLabels': ['Breast Cancer', 'Colon Cancer', 'Healthy Control', 'Melanoma', 'Pancreatic Cancer', 'Prostate Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Namida Lab', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}], 'overallOfficials': [{'name': 'Prashanth Ravishankar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Namida Lab Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Namida Lab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arkansas Urology', 'class': 'UNKNOWN'}, {'name': 'CARTI', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}