Breast CancerNCT05223218
Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study
An observational study of Breast Cancer and Ovarian Cancer, run by Namida Lab at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer
- What is being tested?
- Schirmer strip, a Class I Medical Device typically used to test for dry eye.
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.
Who may be able to join
- 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
Who cannot join
- Less than 18 years of age OR more than 100 years of age
- Concurrent eye infection or trauma
- Acute conjunctivitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Diagnostic Potential of Tear Proteins in Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon Cancer
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Melanoma
- Being tested
- Schirmer strip, a Class I Medical Device typically used to test for dry eye.
- Keywords
- Preventative Screening, Protein Biomarkers, Lacrimal Tear Fluid, Non-invasive, Tear Collection, CLIA Laboratory, Affordable, Proteomics, Metabolomics, Protein Microarray, ELISA assay
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. | |
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. | |
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. | |
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. | |
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. | |
| 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. Receives: Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Cancer-related Biomarkers
A tear protein repertoire will be created to identify key cancer biomarkers
Measured: Dec 2023
Secondary outcomes (1)
Tear Protein Concentrations
The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles.
Measured: Dec 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start25 Aug 2021
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namida Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arkansas Urology, CARTI
- Responsible party
- Sponsor
- Investigators
- Prashanth Ravishankar, PhD, Principal investigator, Namida Lab Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223218
- Sponsor's protocol ID
- IRB#56402
- Status last verified
- Jun 2023
- First submitted
- 24 Jan 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Diagnostic Potential of Tear Proteins in Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon Cancer
- ClinicalTrials.gov ID
- NCT05223218
- Acronym / sponsor ID
- IRB#56402
- Conditions
- Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Melanoma
- Keywords
- Preventative Screening, Protein Biomarkers, Lacrimal Tear Fluid, Non-invasive, Tear Collection, CLIA Laboratory, Affordable, Proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Namida LabIndustry (pharma, biotech, devices)
- Collaborators
- Arkansas Urology, CARTI
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
| Pancreatic Cancer | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
| Colon Cancer | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
| Prostate Cancer | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
| Melanoma | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
| Healthy Control | – | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 years of age OR more than 100 years of age
- Concurrent eye infection or trauma
- Acute conjunctivitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Breast Cancer, Colon Cancer, Healthy Control, Melanoma, Pancreatic Cancer, Prostate Cancer |
Primary outcome
Identify Cancer-related Biomarkers
Time frame: Dec 2023
A tear protein repertoire will be created to identify key cancer biomarkers
1 secondary outcome
Tear Protein Concentrations
Time frame: Dec 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashanth Ravishankar, PhD principal investigator
Namida Lab Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ovarian Cancer, run by Namida Lab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Cancer-related Biomarkers (time frame: Dec 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.