The Role of Inflammation in Ocular Tumours

NCT ID: NCT02909517

Last Updated: 2019-05-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-05-31

Brief Summary

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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. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours

Detailed Description

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Conditions

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Ocular Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Choroidal nevus

Requires distinction from melanoma through diagnostic testing (low-risk features)

cSLO imaging

Intervention Type OTHER

Choroidal indeterminate melanocytic lesion

Requires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features)

cSLO imaging

Intervention Type OTHER

Choroidal melanoma

Requires confirmation of diagnosis and evaluation for potential metatstases

cSLO imaging

Intervention Type OTHER

Suspected metastatic tumour

Requires identification of primary tumour (ie, primary tumour elsewhere)

cSLO imaging

Intervention Type OTHER

Locally treated ocular tumour

Requires followup to evaluate response to treatment and potential change or repeat therapy

cSLO imaging

Intervention Type OTHER

Interventions

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cSLO imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Any tentative clinical diagnosis of:

1. Choroidal nevus (low-risk features):
2. Choroidal indeterminate melanocytic lesion (high-risk features)
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shelley Boyd, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre, Ontario

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Emily Mathieu, PhD

Role: CONTACT

4168646060 ext. 2893

Facility Contacts

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Shelley Boyd, MD

Role: primary

416-864-6060 ext. 2893

Michelle Jagdat, BSc

Role: primary

416-864-6060 ext. 2893

Other Identifiers

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14-416

Identifier Type: -

Identifier Source: org_study_id

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