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The Role of Inflammation in Ocular Tumours

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ClinicalTrials.gov Identifier: NCT02909517
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

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

Condition or disease Intervention/treatment
Ocular Melanoma Other: cSLO imaging

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Inflammation in Ocular Tumours
Study Start Date : March 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Eye Cancer Melanoma

Group/Cohort Intervention/treatment
Choroidal nevus
Requires distinction from melanoma through diagnostic testing (low-risk features)
Other: cSLO imaging
Choroidal indeterminate melanocytic lesion
Requires diagnostic testing for identification and distinction from nevus and melanoma (high-risk features)
Other: cSLO imaging
Choroidal melanoma
Requires confirmation of diagnosis and evaluation for potential metatstases
Other: cSLO imaging
Suspected metastatic tumour
Requires identification of primary tumour (ie, primary tumour elsewhere)
Other: cSLO imaging
Locally treated ocular tumour
Requires followup to evaluate response to treatment and potential change or repeat therapy
Other: cSLO imaging



Primary Outcome Measures :
  1. Identification of macrophages [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909517


Contacts
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Contact: Emily Mathieu, PhD 4168646060 ext 2893 mathieue@smh.ca

Locations
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Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Shelley Boyd, MD    416-864-6060 ext 2893    BoydS@smh.ca   
Princess Margaret Cancer Centre, Ontario Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michelle Jagdat, BSc    416-864-6060 ext 2893    jagdatm@smh.ca   
Principal Investigator: Fil Altomare, MD, FRCSC         
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Shelley Boyd, MD Unity Health Toronto
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02909517    
Other Study ID Numbers: 14-416
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes