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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|ClinicalTrials.gov Identifier: NCT02849145|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Biological: Blood sampling||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)|
|Actual Study Start Date :||September 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2021|
Biological: Blood sampling
7,5 ml of patient peripherical blood will be collected at each blood sample.
- Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection [ Time Frame: Up to one month ]Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
- stability of the circulating tumor DNA on 2 pre-surgery samples [ Time Frame: 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. [ Time Frame: two years ]
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 [ Time Frame: 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. [ Time Frame: Up to one month ]
- Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis) [ Time Frame: Up to one month ]
- Detection of genetic factors for uveal melanoma [ Time Frame: 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 [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849145
|Paris, France, 75005|
|Principal Investigator:||Pascale Mariani, MD||Institut Curie|