Ocular MelanomaNCT02909517
The Role of Inflammation in Ocular Tumours
An observational study of Ocular Melanoma, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
This prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours. The investigators will evaluate 5 groups: 1. Choroidal nevus 2. Choroidal indeterminate melanocytic lesion 3. Choroidal melanoma 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Melanoma
- What is being tested?
- cSLO imaging
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2016to May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential study subjects will be identified from within the circle of care of the attending physicians. Subjects must be 18 years of age or older, be able to understand the study protocol, and provide informed consent. They must be able to attend all three visits
Who may be able to join
- Any tentative clinical diagnosis of:
- Choroidal nevus (low-risk features):
- Choroidal indeterminate melanocytic lesion (high-risk features)
- Choroidal melanoma
- Suspected metastatic tumour (ie, primary tumour elsewhere)
- Locally treated ocular tumours
- Note that a patient can enroll in this study twice, once before treatment and once after, provided that at least one month has passed since initiation of treatment. This patient will count twice (ie, once in each of two study arms)
- Male and female age 18 years and older Ability to provide informed consent
Who cannot join
- Allergy to angiography dye
- Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
- Patients not able to provide consent for the study.
- Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
- Patients < 18 years of age. Any concurrent unrelated eye diagnosis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Shelley Boyd, MD, 416-864-6060 ext. 2893, BoydS@smh.ca
- Recruiting
Princess Margaret Cancer Centre, Ontario
Toronto, Ontario, M5G 2M9
Michelle Jagdat, BSc, 416-864-6060 ext. 2893, jagdatm@smh.ca
Fil Altomare, MD, FRCSC
About this study
This prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.
The investigators will evaluate 5 groups:
- Choroidal nevus
- Choroidal indeterminate melanocytic lesion
- Choroidal melanoma
- Suspected metastatic tumour (ie, primary tumour elsewhere)
- Locally treated ocular tumours
- Conditions
- Ocular Melanoma
- Being tested
- cSLO imaging
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cSLO imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Choroidal nevus | Requires distinction from melanoma through diagnostic testing (low-risk features) Receives: Other: cSLO imaging | |
| Choroidal indeterminate melanocytic lesion | Requires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features) Receives: Other: cSLO imaging | |
| Choroidal melanoma | Requires confirmation of diagnosis and evaluation for potential metatstases Receives: Other: cSLO imaging | |
| Suspected metastatic tumour | Requires identification of primary tumour (ie, primary tumour elsewhere) Receives: Other: cSLO imaging | |
| Locally treated ocular tumour | Requires followup to evaluate response to treatment and potential change or repeat therapy Receives: Other: cSLO imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of macrophages
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular MelanomaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelley Boyd, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909517
- Sponsor's protocol ID
- 14-416
- Status last verified
- May 2019
- First submitted
- 16 Sep 2016
- Last updated
- 23 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inflammation in Ocular Tumours
- ClinicalTrials.gov ID
- NCT02909517
- Acronym / sponsor ID
- 14-416
- Conditions
- Ocular Melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- 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 prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.
The investigators will evaluate 5 groups:
- Choroidal nevus
- Choroidal indeterminate melanocytic lesion
- Choroidal melanoma
- Suspected metastatic tumour (ie, primary tumour elsewhere)
- Locally treated ocular tumours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Choroidal nevus | – | Other: cSLO imagingRequires distinction from melanoma through diagnostic testing (low-risk features) |
| Choroidal indeterminate melanocytic lesion | – | Other: cSLO imagingRequires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features) |
| Choroidal melanoma | – | Other: cSLO imagingRequires confirmation of diagnosis and evaluation for potential metatstases |
| Suspected metastatic tumour | – | Other: cSLO imagingRequires identification of primary tumour (ie, primary tumour elsewhere) |
| Locally treated ocular tumour | – | Other: cSLO imagingRequires followup to evaluate response to treatment and potential change or repeat therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study subjects will be identified from within the circle of care of the attending physicians. Subjects must be 18 years of age or older, be able to understand the study protocol, and provide informed consent. They must be able to attend all three visits
Key inclusion criteria (8 listed)
- Choroidal nevus (low-risk features):
- Choroidal indeterminate melanocytic lesion (high-risk features)
- Choroidal melanoma
- Suspected metastatic tumour (ie, primary tumour elsewhere)
- Locally treated ocular tumours
Key exclusion criteria (5 listed)
- Allergy to angiography dye
- Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
- Patients not able to provide consent for the study.
- Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
- Patients < 18 years of age. Any concurrent unrelated eye diagnosis
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 |
|---|---|---|
| cSLO imaging | Other | Choroidal indeterminate melanocytic lesion, Choroidal melanoma, Choroidal nevus, Locally treated ocular tumour, Suspected metastatic tumour |
Primary outcome
Identification of macrophages
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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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.
Shelley Boyd, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Melanoma, run by Unity Health Toronto at 2 sites in Canada.
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 8 inclusion and 5 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Contact Emily Mathieu, PhD (4168646060 ext. 2893, mathieue@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of macrophages (time frame: 1 week). 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 23 May 2019.