Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biological/Vaccine
|
Biological: Blood sampling
7,5 ml of patient peripherical blood will be collected at each blood sample.
|
Outcome Measures
Primary Outcome Measures
- Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection [Up to one month]
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
Secondary Outcome Measures
- stability of the circulating tumor DNA on 2 pre-surgery samples [Up to one month]
Comparison the circulating tumor DNA rate before/after surgery
- Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up. [two years]
Timepoints : T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years.
- Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis [Up to one month]
Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques
- Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis. [Up to one month]
- Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis) [Up to one month]
- Detection of genetic factors for uveal melanoma [Up to one month]
Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment
- Study of overall survival after HMUM resection [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 years old or more
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Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
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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)).
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Patient able to stand a blood collection.
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Patient explanation given and consent information signed or by legal representative.
Exclusion Criteria:
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Patient without social protection / insurance..
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Patient with hepatic metastasis unresectable by surgery
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Patient with extra-hepatic metastasis.
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Person deprived of liberty or under guardianship
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Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Curie | Paris | France | 75005 |
Sponsors and Collaborators
- Institut Curie
Investigators
- Principal Investigator: Pascale Mariani, MD, Institut Curie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC 2014-06 ctDNA R0