Choroidal MelanomactDNA MUNCT02875652
Circulating Tumoral DNA in Choroidal Melanoma (ctDNA MU)
A study testing Blood sampling in people with Choroidal Melanoma, run by Institut Curie at 1 site in France.
Trial summary
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2013to 2 Apr 2019
- 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 a recent choroidal melanoma before the start of the specific treatment.
- Patient able to stand a blood collection.
- Work-up for extension (CT).
- Patient explanation given and consent information signed or by legal representative
Who cannot join
- Patient without social protection / insurance.
- 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 of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
Read the detailed description
This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
The patient will have a blood sample at the following times :
- T0: before treatment of the primary tumor.
- T1: 1 months after the end of the local treatment.
- T2: at 7 months.
- Tn: every 6 months up to 3 years.
- Conditions
- Choroidal Melanoma
- Being tested
- Blood sampling
- Keywords
- circulation 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
3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling | Experimental | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of the change of the circulating tumor DNA from baseline at 3 years
Measured: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
Secondary outcomes (2)
Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
Measured: 3 years
Comparison of the circulating tumor DNA rate to hepatic imaging if available.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start21 Mar 2013
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Desjardins, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875652
- Sponsor's protocol ID
- IC 2012-08
- Acronym
- ctDNA MU
- Status last verified
- Jan 2024
- First submitted
- 18 Aug 2016
- Last updated
- 31 Jan 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Circulating Tumoral DNA Evolution in Plasma in Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT02875652
- Acronym / sponsor ID
- ctDNA MU / IC 2012-08
- Conditions
- Choroidal Melanoma
- Keywords
- circulation tumor DNA, choroidal melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 21 Mar 2013 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 23 Aug 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.
Quantification and follow-up during 3 years of circulating tumoral DNA in patients with choroidal melanoma
Detailed description
This study is a prospective, open-labelled, monocentric trial. The aim is to observe, in patient with choroidal melanoma (any stage of the disease), the prevalence of the circulating tumor DNA at the diagnostic and its evolution during 3 years.
The patient will have a blood sample at the following times :
- T0: before treatment of the primary tumor.
- T1: 1 months after the end of the local treatment.
- T2: at 7 months.
- Tn: every 6 months up to 3 years.
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 | 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 a recent choroidal melanoma before the start of the specific treatment.
- Patient able to stand a blood collection.
- Work-up for extension (CT).
- Patient explanation given and consent information signed or by legal representative
Key exclusion criteria (3 listed)
- Patient without social protection / insurance.
- 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 sampling3 vials of 7,5 ml of peripherical blood will be collected at each blood sample. | Biological | Blood sampling |
Primary outcome
Assesment of the change of the circulating tumor DNA from baseline at 3 years
Time frame: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.
2 secondary outcomes
Compare the treatment effects of the primary tumor (protontherapy, iodine plaque, enucleation) on the rate of circulating tumoral DNA.
Time frame: 3 years
Comparison of the circulating tumor DNA rate to hepatic imaging if available.
Time frame: 3 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 31 Jan 2024.
- 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.
Related trials for Choroidal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Active, not recruitingPhase 3
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
RecruitingPhase 3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Uveal Melanoma
Enrolling by invitationObservational study
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
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.
Laurence Desjardins, 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, 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 3 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 31 Jan 2024. 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?
Assesment of the change of the circulating tumor DNA from baseline at 3 years (time frame: T0: before treatment; T1: 1 month after local treatment; T2: at 7 months; Tn : every 6 months up to 3 years.). 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 31 Jan 2024.