Clinical trial
Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
Name
IC 2012-08
Description
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
Trial arms
Trial start
2013-03-21
Estimated PCD
2019-04-02
Trial end
2019-04-02
Status
Completed
Treatment
Blood sampling
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.
Arms:
Blood sampling
Size
800
Primary endpoint
Assesment of the change of the circulating tumor DNA from baseline at 3 years
T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 800, 'type': 'ACTUAL'}}
Updated at
2024-01-31
1 organization
1 product
1 indication
Organization
Institut CurieProduct
Blood samplingIndication
Choroidal Melanoma