Back to resultsCirculating Tumoral DNA in Choroidal Melanoma (ctDNA MU) (ctDNA MU)
Primary Purpose
Choroidal Melanoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Choroidal Melanoma focused on measuring circulation tumor DNA, choroidal melanoma
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years old or more.
- Patient with a recent choroidal melanoma before the start of the specific treatment.
- Patient able to stand a blood collection.
- Work-up for extension (CT).
- Patient explanation given and consent information signed or by legal representative
Exclusion Criteria:
- Patient without social protection / insurance.
- Person deprived of liberty or under guardianship.
- Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood sampling
Arm Description
Outcomes
Primary Outcome Measures
Assesment of the change of the circulating tumor DNA from baseline at 3 years
Secondary Outcome Measures
Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
Comparison of the circulating tumor DNA rate to hepatic imaging if available.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875652
Brief Title
Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)
Acronym
ctDNA MU
Official Title
Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2013 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
Detailed Description
This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
The patient will have a blood sample at the following times :
T0: before treatment of the primary tumor.
T1: 1 months after the end of the local treatment.
T2: at 7 months.
Tn: every 6 months up to 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Melanoma
Keywords
circulation tumor DNA, choroidal melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood sampling
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.
Primary Outcome Measure Information:
Title
Assesment of the change of the circulating tumor DNA from baseline at 3 years
Time Frame
T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
Secondary Outcome Measure Information:
Title
Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
Time Frame
3 years
Title
Comparison of the circulating tumor DNA rate to hepatic imaging if available.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years old or more.
Patient with a recent choroidal melanoma before the start of the specific treatment.
Patient able to stand a blood collection.
Work-up for extension (CT).
Patient explanation given and consent information signed or by legal representative
Exclusion Criteria:
Patient without social protection / insurance.
Person deprived of liberty or under guardianship.
Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Desjardins, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)
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