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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
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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
Uveal Melanoma Biological: Blood sampling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
Experimental: Biological/Vaccine Biological: Blood sampling
7,5 ml of patient peripherical blood will be collected at each blood sample.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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

  4. Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis. [ Time Frame: Up to one month ]
  5. 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 ]
  6. 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

  7. Study of overall survival after HMUM resection [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Pascale Mariani, MD Institut Curie

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02849145     History of Changes
Other Study ID Numbers: IC 2014-06
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Institut Curie:
Circulating tumor DNA

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases