Uveal Melanoma and Brachytheraphy: Long-term Outcomes.

October 3, 2020 updated by: Gilda Cennamo, Federico II University

Long-term Outcomes in Uveal Melanoma After Ruthenium-106 Brachytherapy

This study investigated the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival in patients affected by uveal melanoma and undergoing Ru-106 plaque brachytherapy between February 2011 and March 2020

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 40 years with uveal melanoma and they underwent Ruthenium 106 brachytherapy

Description

Inclusion Criteria:

  • age older than 40 years
  • diagnosis of uveal melanoma

Exclusion Criteria:

  • age older than 80 years
  • No diagnosis of uveal melanoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate long-term outcomes in patients underwent brachytherapy for uveal melanoma
Time Frame: Mean follow-up was 4 years (3 months-9 years)
To investigate the visual and anatomical outcomes, tumor control, tumor recurrence, distant metastasis and cancer free survival
Mean follow-up was 4 years (3 months-9 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

March 20, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

October 3, 2020

First Submitted That Met QC Criteria

October 3, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 3, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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