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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: Institut Curie

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]

    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 [ 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 ]


Original Secondary Outcome:

  • stability of the circulating tumor DNA on 2 pre-surgery samples [ Time Frame: Up to one month ]
  • 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 ]

    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.

  • Search of GNA11 or GNAQ mutation on one of the hepatic metastasis [ Time Frame: Up to one month ]
  • 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 ]
  • Search of genetic factors for uveal melanoma and predictive evidence of the clinical response for possible future treatment [ Time Frame: Up to one month ]
  • Study of overall survival after HMUM resection [ Time Frame: 5 years ]


Information By: Institut Curie

Dates:
Date Received: July 13, 2016
Date Started: September 2014
Date Completion: October 2021
Last Updated: January 20, 2017
Last Verified: January 2017