Uveal MelanomaSALOMENCT04424719
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
A study testing Blood test in people with Uveal Melanoma, run by Institut Curie at 1 site in France.
Trial summary
Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2020to 7 Jul 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged of 18 years or more.
- Patient with uveal melanoma with high metastatic relapse risk defined as :
- T2b/c/d ou ≥ T3,
- or chromosom 3 or chromosom 8 abnormality by CGH array.
- Completion of treatment of the primary tumor ≤ 2 months.
- Patient able to comply with the schedule of visits and blood samples of the study.
- Signed informed consent form or legal representative.
Who cannot join
- Patient without french social insurance.
- Any social, medical or psychological condition making the research process impossible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Curie
Paris, 75005
Marie-Emmanuelle Legrier, PhD, 0156245649, drci.promotion@curie.fr
Sophie PIPERNO-NEUMANN, MD
About this study
Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.
Read the detailed description
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :
(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).
(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.
- M0 : during the first medical oncology visit.
- At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
- At the diagnosis of metastasis.
- At each significant event during the metastatic disease (surgery, treatment response or progression).
- Conditions
- Uveal Melanoma
- Being tested
- Blood test
- Keywords
- uveal melanoma
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Also called MRI in routine
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :
(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).
(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.
- M0 : during the first medical oncology visit.
- At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
- At the diagnosis of metastasis.
- At each significant event during the metastatic disease (surgery, treatment response or progression).
| Study group | Role | What they receive |
|---|---|---|
| Patients with uveal melanoma | Other | High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. For enucleated patients, a blood sample is required according to the study schedule. Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Measured: 120 months
Biological study (lymphocytes)
lymphocyte phenotype analysis with biological tests
Measured: 120 months
Biological study (ctDNA)
circulating tumor DNA analysis with biological tests
Measured: 120 months
Secondary outcomes (8)
Biological samples prospective collection (ctDNA)
collection of biological samples (circulating tumor DNA analyses)
Measured: 120 months
Biological samples prospective collection (immune-monitoring analyses)
collection of biological samples (immune-monitoring analyses) with biological tests
Measured: 120 months
Biological samples prospective collection (sequencing analyses)
collection of biological samples (sequencing analyses) with biological tests
Measured: 120 months
Comparison of clinical and imaging data (MRI)
Comparison of imaging data (MRI) between the patients with and without identified biomarkers (biological tests)
Measured: 120 months
Comparison of clinical and imaging data (clinical data)
Comparison of clinical data between the patients with and without identified biomarkers (biological tests)
Measured: 120 months
Univariate analysis of the prognostic value of identified biomarkers
prognostic value of identified biomarkers analysis with biological tests
Measured: 120 months
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
Multivariate analysis of the prognostic value of identifies biomarkers (biological tests) adjusted for clinical (medical patients records) and imaging data (MRI)
Measured: 120 months
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
Analysis of discordant cases regarding genomic/tumor size prognostic factors
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jul 2020
- Primary completion7 Jul 2037 (estimated)
- Study completion7 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Piperno-Neumann, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424719
- Sponsor's protocol ID
- IC2019-13
- Acronym
- SALOME
- Status last verified
- Jul 2025
- First submitted
- 18 May 2020
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
- ClinicalTrials.gov ID
- NCT04424719
- Acronym / sponsor ID
- SALOME / IC2019-13
- Conditions
- Uveal Melanoma
- Keywords
- uveal melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 7 Jul 2037 (estimated)
- Study completion
- 7 Jul 2037 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.
Detailed description
High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :
(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).
(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.
- M0 : during the first medical oncology visit.
- At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
- At the diagnosis of metastasis.
- At each significant event during the metastatic disease (surgery, treatment response or progression).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with uveal melanoma | Other | Other: Blood testHigh risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. For enucleated patients, a blood sample is required according to the study schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged of 18 years or more.
- Patient with uveal melanoma with high metastatic relapse risk defined as :
- Completion of treatment of the primary tumor ≤ 2 months.
- Patient able to comply with the schedule of visits and blood samples of the study.
- Signed informed consent form or legal representative.
Key exclusion criteria (2 listed)
- Patient without french social insurance.
- Any social, medical or psychological condition making the research process impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testAlso: MRI in routineHigh risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule : (i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines). (ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research. * M0 : during the first medical oncology visit. * At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120). * At the diagnosis of metastasis. * At each significant event during the metastatic disease (surgery, treatment response or progression). | Other | Patients with uveal melanoma |
Primary outcome
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers
Time frame: 120 months
metastatic events and treatments reports correlation with their ocrresponding biomarquers
Biological study (lymphocytes)
Time frame: 120 months
lymphocyte phenotype analysis with biological tests
Biological study (ctDNA)
Time frame: 120 months
circulating tumor DNA analysis with biological tests
8 secondary outcomes
Biological samples prospective collection (ctDNA)
Time frame: 120 months
Biological samples prospective collection (immune-monitoring analyses)
Time frame: 120 months
Biological samples prospective collection (sequencing analyses)
Time frame: 120 months
Comparison of clinical and imaging data (MRI)
Time frame: 120 months
Comparison of clinical and imaging data (clinical data)
Time frame: 120 months
Univariate analysis of the prognostic value of identified biomarkers
Time frame: 120 months
Multivariate analysis of the prognostic value of identifies biomarkers adjusted for clinical and imaging data
Time frame: 120 months
Analysis of discordant cases regarding genomic/tumor size prognostic factors and outcomes
Time frame: 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Piperno-Neumann, MD principal investigator
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Uveal Melanoma, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Piperno-Neumann, MD (01 44 32 46 72, sophie.piperno-neumann@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the metastatic events and treatments in high risk UM patients and correlation to biomarkers (time frame: 120 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.