Metastatic MelanomaMELCIRCNCT02862743
Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
A study testing patients with metastatic melanoma in people with Metastatic Melanoma, run by CHU de Reims at 1 site in France.
Trial summary
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- patients with metastatic melanoma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2016to 31 Dec 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
- patient with melanoma confirmed histologically
- patient with metastatic melanoma (stage III unresectable or stage IV)
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Who cannot join
- Metastatic tumor whose origin is doubtful (uncertain melanoma)
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.
Read the detailed description
The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
The secondary objectives of this study will be:
- Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
- Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA
- Conditions
- Metastatic Melanoma
- Being tested
- patients with metastatic melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients with metastatic melanomaOther
Blood sample to realize molecular characterization of melanoma
| Study group | Role | What they receive |
|---|---|---|
| patients with metastatic melanoma | Experimental | patients with metastatic melanoma (stage III unresectable or stage IV) Receives: Other: patients with metastatic melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start14 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862743
- Sponsor's protocol ID
- PO15097*
- Acronym
- MELCIRC
- Status last verified
- Sep 2022
- First submitted
- 8 Aug 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
Beaudoux O, Riffaud L, Barbe C, Grange F. Prognostic factors and incidence of primary mucosal melanoma: a population-based study in France. Eur J Dermatol. 2018 Oct 1;28(5):654-660. doi: 10.1684/ejd.2018.3398.
PubMed 30378540
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Advanced Stage Melanoma by Blood Sampling
- ClinicalTrials.gov ID
- NCT02862743
- Acronym / sponsor ID
- MELCIRC / PO15097*
- Conditions
- Metastatic Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 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.
Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies.
In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.
Detailed description
The main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood.
The secondary objectives of this study will be:
- Study the concordance between mutations in circulating tumor DNA and mutations in tumor tissue - Study the associations between mutational profiles and clinical and histological features of melanoma.
- Study the prognostic impact on survival of the identified genetic profile from the circulating tumor DNA
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with metastatic melanoma | Experimental | Other: patients with metastatic melanomapatients with metastatic melanoma (stage III unresectable or stage IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with melanoma confirmed histologically
- patient with metastatic melanoma (stage III unresectable or stage IV)
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Key exclusion criteria (1 listed)
- Metastatic tumor whose origin is doubtful (uncertain melanoma)
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 |
|---|---|---|
| patients with metastatic melanomaBlood sample to realize molecular characterization of melanoma | Other | patients with metastatic melanoma |
Primary outcome
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood
Time frame: Day 0
Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)
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 21 Jan 2026.
- Results publication: PubMed 30378540Beaudoux O, Riffaud L, Barbe C, Grange F. Prognostic factors and incidence of primary mucosal melanoma: a population-based study in France. Eur J Dermatol. 2018 Oct 1;28(5):654-660. doi: 10.1684/ejd.2018.3398.
Related trials for Metastatic Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patients with metastatic melanoma in people with Metastatic Melanoma, run by CHU de Reims 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 1 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 21 Jan 2026. 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?
Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood (time frame: Day 0). 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 NCT02862743, 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 21 Jan 2026.