Clinical trial

Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)

Name

IC 2014-06 ctDNA R0

Description

Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

Trial arms

Trial start

2014-09-01

Estimated PCD

2020-02-25

Trial end

2020-02-25

Status

Completed

Treatment

Blood sampling

7,5 ml of patient peripherical blood will be collected at each blood sample.

Arms:

Biological/Vaccine

Size

Primary endpoint

Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection

Up to one month

Eligibility criteria

Inclusion Criteria: 1. Aged 18 years old or more 2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0). 3. No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)). 4. Patient able to stand a blood collection. 5. Patient explanation given and consent information signed or by legal representative. Exclusion Criteria: 6. Patient without social protection / insurance.. 7. Patient with hepatic metastasis unresectable by surgery 8. Patient with extra-hepatic metastasis. 9. Person deprived of liberty or under guardianship 10. 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': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-01-31

1 organization

1 product

1 indication

Organization

Institut Curie

Product

Blood sampling

Indication

Uveal melanoma