Uveal MelanomactDNA R0NCT02849145
Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)
A study testing Blood sampling in people with Uveal Melanoma, run by Institut Curie at 1 site in France.
Trial 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 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 sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (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
Read the 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.
- Conditions
- Uveal Melanoma
- Being tested
- Blood sampling
- Keywords
- Circulating tumor DNA
- 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 samplingBiological
7,5 ml of patient peripherical blood will be collected at each blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine | Experimental | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection
Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection.
Measured: Up to one month
Secondary outcomes (7)
stability of the circulating tumor DNA on 2 pre-surgery samples
Comparison the circulating tumor DNA rate before/after surgery
Measured: 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.
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.
Measured: two years
Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis
Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques
Measured: Up to one month
Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.
Measured: Up to one month
Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)
Measured: Up to one month
Detection of genetic factors for uveal melanoma
Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment
Measured: Up to one month
Study of overall survival after HMUM resection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startSep 2014
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Mariani, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849145
- Sponsor's protocol ID
- IC 2014-06
- Acronym
- ctDNA R0
- Status last verified
- Sep 2025
- First submitted
- 13 Jul 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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.
Publications
Mariani P, Bidard FC, Rampanou A, Houy A, Servois V, Ramtohul T, Pierron G, Chevrier M, Renouf B, Lantz O, Gardrat S, Vincent-Salomon A, Roman-Roman S, Rodrigues M, Piperno-Neumann S, Cassoux N, Stern MH, Renault S. Circulating Tumor DNA as a Prognostic Factor in Patients With Resectable Hepatic Metastases of Uveal Melanoma. Ann Surg. 2023 Oct 1;278(4):e827-e834. doi: 10.1097/SLA.0000000000005822. Epub 2023 Feb 27.
PubMed 36847256
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)
- ClinicalTrials.gov ID
- NCT02849145
- Acronym / sponsor ID
- ctDNA R0 / IC 2014-06
- Conditions
- Uveal Melanoma
- Keywords
- Circulating tumor DNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 29 Jul 2016 (estimated)
- 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.
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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological/Vaccine | Experimental | Biological: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 sampling7,5 ml of patient peripherical blood will be collected at each blood sample. | Biological | Biological/Vaccine |
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.
7 secondary outcomes
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
Detection 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
Detection of genetic factors for uveal melanoma
Time frame: Up to one month
Study of overall survival after HMUM resection
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 36847256Mariani P, Bidard FC, Rampanou A, Houy A, Servois V, Ramtohul T, Pierron G, Chevrier M, Renouf B, Lantz O, Gardrat S, Vincent-Salomon A, Roman-Roman S, Rodrigues M, Piperno-Neumann S, Cassoux N, Stern MH, Renault S. Circulating Tumor DNA as a Prognostic Factor in Patients With Resectable Hepatic Metastases of Uveal Melanoma. Ann Surg. 2023 Oct 1;278(4):e827-e834. doi: 10.1097/SLA.0000000000005822. Epub 2023 Feb 27.
- 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. This study is not recruiting at the moment.
Pascale Mariani, 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 sampling 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection (time frame: Up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02849145, which also lists 1 linked publication.
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 19 Sep 2025.