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

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Brief Title

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

Official Title

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

Brief Summary

      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

Detailed Description

      The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to
      evaluate 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.

      The patient will have a blood sample before and after the surgery and during the post-surgery
      follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his
      follow-up of the study.

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 stability of the circulating tumor DNA on 2 pre-surgery samples

Condition

Uveal Melanoma

Intervention

Blood sampling

Study Arms / Comparison Groups

 Biological/Vaccine
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

60

Start Date

September 2014

Completion Date

February 25, 2020

Primary Completion Date

February 25, 2020

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pascale Mariani, MD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT02849145

Organization ID

IC 2014-06 ctDNA R0

Responsible Party

Sponsor

Study Sponsor

Institut Curie

Study Sponsor

Pascale Mariani, MD, Principal Investigator, Institut Curie

Verification Date

August 2020