Choroidal Melanoma, DiffuseNCT01334008
Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
A study testing Blood sampling in people with Choroidal Melanoma, Diffuse, run by Institut Curie at 1 site in France.
Trial summary
Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma, Diffuse
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to May 2012
- 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
- Age > or = 18 years.
- Patient with a metastatic choroidal melanoma.
- Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
- Patient able to stand a blood collection.
- Signed written informed consent approved by competent authority and ethic committee.
Who cannot join
- Patient without social protection/insurance.
- Current pregnancy and lactation.
- All social, medical, psychological, situations making the study impossible.
- Person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma
Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.
Read the detailed description
Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.
Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.
- Conditions
- Choroidal Melanoma, Diffuse
- Being tested
- Blood sampling
- Keywords
- Circulating tumor DNA, Choroidal 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 samplingBiological
30ml of patient peripherical blood will be collected
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling | Other | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and development of circulating tumor DNA detection techniques
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
Measured: 2 years
Secondary outcomes (1)
Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.
The methods of detection which will be used such as the BEAMing, the PAP (Pyrophosphorolysis-activated polymerization) and NGS (next sequencing generation)is techniques of a big specificity capable of detecting a mutant copy among 1.104 wild copies for the BEAMing, 2.109 for the PAP and 1.105 for the NGS. The sensibility of these techniques is limited by the quantity of genomic DNA which we can extract from the sample of blood.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionMay 2012
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 Choroidal Melanoma, DiffuseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT01334008
- Sponsor's protocol ID
- IC 2010-02
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2011
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Bidard FC, Madic J, Mariani P, Piperno-Neumann S, Rampanou A, Servois V, Cassoux N, Desjardins L, Milder M, Vaucher I, Pierga JY, Lebofsky R, Stern MH, Lantz O. Detection rate and prognostic value of circulating tumor cells and circulating tumor DNA in metastatic uveal melanoma. Int J Cancer. 2014 Mar 1;134(5):1207-13. doi: 10.1002/ijc.28436. Epub 2013 Sep 3.
PubMed 23934701
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT01334008
- Acronym / sponsor ID
- IC 2010-02
- Conditions
- Choroidal Melanoma, Diffuse
- Keywords
- Circulating tumor DNA, Choroidal Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Apr 2011 (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.
Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.
Detailed description
Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.
Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sampling | Other | 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)
- Age > or = 18 years.
- Patient with a metastatic choroidal melanoma.
- Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
- Patient able to stand a blood collection.
- Signed written informed consent approved by competent authority and ethic committee.
Key exclusion criteria (4 listed)
- Patient without social protection/insurance.
- Current pregnancy and lactation.
- All social, medical, psychological, situations making the study impossible.
- Person deprived of liberty.
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 sampling30ml of patient peripherical blood will be collected | Biological | Blood sampling |
Primary outcome
Assessment and development of circulating tumor DNA detection techniques
Time frame: 2 years
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
1 secondary outcome
Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.
Time frame: 2 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 24 Nov 2025.
- Results publication: PubMed 23934701Bidard FC, Madic J, Mariani P, Piperno-Neumann S, Rampanou A, Servois V, Cassoux N, Desjardins L, Milder M, Vaucher I, Pierga JY, Lebofsky R, Stern MH, Lantz O. Detection rate and prognostic value of circulating tumor cells and circulating tumor DNA in metastatic uveal melanoma. Int J Cancer. 2014 Mar 1;134(5):1207-13. doi: 10.1002/ijc.28436. Epub 2013 Sep 3.
- 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.
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.
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 sampling in people with Choroidal Melanoma, Diffuse, 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 4 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 24 Nov 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?
Assessment and development of circulating tumor DNA detection techniques (time frame: 2 years). 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 NCT01334008, 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 24 Nov 2025.