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NCT Number: NCT02849145

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years old or more
  • Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
  • 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)).
  • Patient able to stand a blood collection.
  • Patient explanation given and consent information signed or by legal representative.

Exclusion criteria

  • Patient without social protection / insurance..
  • Patient with hepatic metastasis unresectable by surgery
  • Patient with extra-hepatic metastasis.
  • Person deprived of liberty or under guardianship
  • Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Treatment and study plan

Blood sampling

Biological

7,5 ml of patient peripherical blood will be collected at each blood sample.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: ctDNA R0

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2016
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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