Metastatic MelanomaNCT01558349
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques
An observational study of Metastatic Melanoma, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- How many people
- 73 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Jun 2013to 27 Jun 2017
- Phase
- Observational
- 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
Study population: The two cohorts in this study are composed of (1) patients suffering from metastatic melanome and (2) hospitalized patients with no history of cancer.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available, within the hours of his/her normally scheduled medical care, for blood sampling at 8 am and 4 pm on the same day.
- Stage 4 melanoma, without other associated neoplasms
- Patient without cancer, nor history of cancer
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
Show all 9Show fewer
- The patient has a contra-indication for a treatment used in this study
- Stage 1 to 3 melanoma, or other types of cancer
- History of cancer
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
Official title: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.
Read the detailed description
The secondary objectives of this study include:
- To compare the following elements between the two patient groups:
- the number of CMCs per ml of blood as determined by EPISPOT
- the number of CMCs per ml of blood as determined by CellSearch
- the percentage of patients with at least 2 CMCs per ml of blood according to the two techniques
- the % of CMCs expressing KI67
- the % of CMCs expressions S100 (only the EPISPOT technique)
- To compare the EPISPOT and CellSearch techniques is terms of the following:
- the number of CMCs detected per ml blood
- the number of CMCs expressing antigen KI67
- To re-evaluate the 2-CMC per ml blood threshold
- Conditions
- Metastatic Melanoma
- Keywords
- Epispot, CellSearch, Circulating melanoma cells, circulating cells
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized controls | Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer. | |
| Metastatic melanoma | This cohort includes patients with metastatic melanoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of at least 2 CMCs per ml blood, both techniques
Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
Measured: Day 1 at 8 am
Secondary outcomes (6)
CMCs per ml blood, Epispot
The number of CMCs per ml blood as determined by the Epispot technique
Measured: Day 1 at 8 am
CMCs per ml blood, CellSearch
The number of CMCs per ml blood as determined by the CellSearch technique
Measured: Day 1 at 8 am
delta CMC
The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)
Measured: Day 1 at 8 am
% delta CMC
The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch*100
Measured: Day 1 at 8 am
Presence/absence of KI67 antigen markers
Measured: Day 1 at 8 am
% cells with S100 protein markers
Measured: Day 1 at 8 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study start27 Jun 2013
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
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 Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Meunier, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558349
- Sponsor's protocol ID
- LOCAL/2011/LM-05
- Other IDs
- 2012-A00236-37
- Status last verified
- Jan 2017
- First submitted
- 17 Mar 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Cayrefourcq L, De Roeck A, Garcia C, Stoebner PE, Fichel F, Garima F, Perriard F, Daures JP, Meunier L, Alix-Panabieres C. S100-EPISPOT: A New Tool to Detect Viable Circulating Melanoma Cells. Cells. 2019 Jul 20;8(7):755. doi: 10.3390/cells8070755.
PubMed 31330795
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques
- ClinicalTrials.gov ID
- NCT01558349
- Acronym / sponsor ID
- LOCAL/2011/LM-05
- Conditions
- Metastatic Melanoma
- Keywords
- Epispot, CellSearch, Circulating melanoma cells, circulating cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Jun 2013 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 20 Mar 2012 (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.
The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.
Detailed description
The secondary objectives of this study include:
- To compare the following elements between the two patient groups:
- the number of CMCs per ml of blood as determined by EPISPOT
- the number of CMCs per ml of blood as determined by CellSearch
- the percentage of patients with at least 2 CMCs per ml of blood according to the two techniques
- the % of CMCs expressing KI67
- the % of CMCs expressions S100 (only the EPISPOT technique)
- To compare the EPISPOT and CellSearch techniques is terms of the following:
- the number of CMCs detected per ml blood
- the number of CMCs expressing antigen KI67
- To re-evaluate the 2-CMC per ml blood threshold
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized controls | – | –Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer. |
| Metastatic melanoma | – | –This cohort includes patients with metastatic melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The two cohorts in this study are composed of (1) patients suffering from metastatic melanome and (2) hospitalized patients with no history of cancer.
Key inclusion criteria (5 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available, within the hours of his/her normally scheduled medical care, for blood sampling at 8 am and 4 pm on the same day.
- Stage 4 melanoma, without other associated neoplasms
- Patient without cancer, nor history of cancer
Key exclusion criteria (9 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence/absence of at least 2 CMCs per ml blood, both techniques
Time frame: Day 1 at 8 am
Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques
6 secondary outcomes
CMCs per ml blood, Epispot
Time frame: Day 1 at 8 am
CMCs per ml blood, CellSearch
Time frame: Day 1 at 8 am
delta CMC
Time frame: Day 1 at 8 am
% delta CMC
Time frame: Day 1 at 8 am
Presence/absence of KI67 antigen markers
Time frame: Day 1 at 8 am
% cells with S100 protein markers
Time frame: Day 1 at 8 am
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 Nov 2025.
- Results publication: PubMed 31330795Cayrefourcq L, De Roeck A, Garcia C, Stoebner PE, Fichel F, Garima F, Perriard F, Daures JP, Meunier L, Alix-Panabieres C. S100-EPISPOT: A New Tool to Detect Viable Circulating Melanoma Cells. Cells. 2019 Jul 20;8(7):755. doi: 10.3390/cells8070755.
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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.
Laurent Meunier, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 9 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 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 2 sites 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?
Presence/absence of at least 2 CMCs per ml blood, both techniques (time frame: Day 1 at 8 am). 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 NCT01558349, 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 Nov 2025.