MelanomaIMMUMELANCT01336270
Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients
An observational study of Melanoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- biological collection
- Type of treatment
- Injection or infusion
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Mar 2014
- 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: Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage III melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: stage IV Patient achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment(processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
Who may be able to join
- Patients with confirmed melanoma-patients informed of the aims of the study , the modalities
- Patients who signed the consent form ou a non opposition form signed by the patient or by a relative
- According to study part:
- Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage IV melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: Patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment (processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
Who cannot join
- Refusal to take part in the study (patient or relative)
- Contraindications known to the xylocaine (groups 1,2, and 4)
- No affiliated to the social security system (groups 1, 2, and 4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression
Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.
Read the detailed description
The study is divided in 4 parts:
Part 1: study of cellular infiltrate (lymphocytes) performed on large primary melanoma and cutaneous metastasis ( fresh samples) Part 2: NK cells study on metastatic regional lymph nodes ( fresh samples) and blood samples Part 3: a retrospective study of macrophages in sentinel lymph nodes and in corresponding primary melanomas Part 4: study of the cellular modulation by the chemotherapy (DTIC or cisplatin or inhibitor of B-raf) which(who) will be made on two cutaneous metastases by patient (one taken before the treatment(processing) and one taken during the evaluation after 2 or 3 cycles of treatment(processing))
- Conditions
- Melanoma
- Being tested
- biological collection
- Keywords
- Melanoma, NK cells, T lymphocytes, macrophages
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological collectionOther
Also called to collect some human cell samples in melanoma
to collect some human cell samples in melanoma
| Study group | Role | What they receive |
|---|---|---|
| MELANOMA 10mm | patients with a melanoma larger than 10mm or with cutaneous metastasis Receives: Other: biological collection | |
| STAGE III MELANOMA | stage III melanoma patients who shall undergo a regional lymph node dissection Receives: Other: biological collection | |
| SENTINEL NODE PROCEDURE | retrospective study of patients who underwent a sentinel node procedure Receives: Other: biological collection | |
| STAGE IV MELANOMA | stage IV patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment(processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases Receives: Other: biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of cellular infiltrate - Group 1
Impact of cellular infiltrate on disease free survival at 2 years
Measured: 2 years
Impact of NK cell infiltrate - Group 2 and 3
Impact of NK cell infiltrate in metastatic lymph node on disease free survival and overall survival at 2 and 3 years
Measured: 2 and 3 years
Modifications of cellular infiltrate - Group 4
Modifications of cellular infiltrate after chemotherapy (after 2 months)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionMar 2014
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 MelanomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie Françoise Avril, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336270
- Sponsor's protocol ID
- P090405
- Acronym
- IMMUMELA
- Status last verified
- Mar 2026
- First submitted
- 14 Apr 2011
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Messaoudene M, Perier A, Fregni G, Neves E, Zitvogel L, Cremer I, Chanal J, Sastre-Garau X, Deschamps L, Marinho E, Larousserie F, Maubec E, Avril MF, Caignard A. Characterization of the Microenvironment in Positive and Negative Sentinel Lymph Nodes from Melanoma Patients. PLoS One. 2015 Jul 28;10(7):e0133363. doi: 10.1371/journal.pone.0133363. eCollection 2015.
PubMed 26218530
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression
- ClinicalTrials.gov ID
- NCT01336270
- Acronym / sponsor ID
- IMMUMELA / P090405
- Conditions
- Melanoma
- Keywords
- Melanoma, NK cells, T lymphocytes, macrophages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 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.
Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.
Detailed description
The study is divided in 4 parts:
Part 1: study of cellular infiltrate (lymphocytes) performed on large primary melanoma and cutaneous metastasis ( fresh samples) Part 2: NK cells study on metastatic regional lymph nodes ( fresh samples) and blood samples Part 3: a retrospective study of macrophages in sentinel lymph nodes and in corresponding primary melanomas Part 4: study of the cellular modulation by the chemotherapy (DTIC or cisplatin or inhibitor of B-raf) which(who) will be made on two cutaneous metastases by patient (one taken before the treatment(processing) and one taken during the evaluation after 2 or 3 cycles of treatment(processing))
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MELANOMA 10mm | – | Other: biological collectionpatients with a melanoma larger than 10mm or with cutaneous metastasis |
| STAGE III MELANOMA | – | Other: biological collectionstage III melanoma patients who shall undergo a regional lymph node dissection |
| SENTINEL NODE PROCEDURE | – | Other: biological collectionretrospective study of patients who underwent a sentinel node procedure |
| STAGE IV MELANOMA | – | Other: biological collectionstage IV patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment(processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage III melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: stage IV Patient achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment(processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
Key inclusion criteria (4 listed)
- Patients with confirmed melanoma-patients informed of the aims of the study , the modalities
- Patients who signed the consent form ou a non opposition form signed by the patient or by a relative
- Part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis Part 2: stage IV melanoma patients who shall undergo a regional lymph node dissection Part 3: retrospective study of patients who underwent a sentinel node procedure Part 4: Patients achieves of inoperable melanomas the stage(stadium) III or IV that must receive in treatment (processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of B-raf) and carrier of at least two cutaneous metastases
Key exclusion criteria (3 listed)
- Refusal to take part in the study (patient or relative)
- Contraindications known to the xylocaine (groups 1,2, and 4)
- No affiliated to the social security system (groups 1, 2, and 4)
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 |
|---|---|---|
| biological collectionAlso: to collect some human cell samples in melanomato collect some human cell samples in melanoma | Other | MELANOMA 10mm, SENTINEL NODE PROCEDURE, STAGE III MELANOMA, STAGE IV MELANOMA |
Primary outcome
Impact of cellular infiltrate - Group 1
Time frame: 2 years
Impact of cellular infiltrate on disease free survival at 2 years
Impact of NK cell infiltrate - Group 2 and 3
Time frame: 2 and 3 years
Impact of NK cell infiltrate in metastatic lymph node on disease free survival and overall survival at 2 and 3 years
Modifications of cellular infiltrate - Group 4
Time frame: 2 months
Modifications of cellular infiltrate after chemotherapy (after 2 months)
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 6 Mar 2026.
- Results publication: PubMed 26218530Messaoudene M, Perier A, Fregni G, Neves E, Zitvogel L, Cremer I, Chanal J, Sastre-Garau X, Deschamps L, Marinho E, Larousserie F, Maubec E, Avril MF, Caignard A. Characterization of the Microenvironment in Positive and Negative Sentinel Lymph Nodes from Melanoma Patients. PLoS One. 2015 Jul 28;10(7):e0133363. doi: 10.1371/journal.pone.0133363. eCollection 2015.
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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.
Marie Françoise Avril, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Assistance Publique - Hôpitaux de Paris 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 4 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 6 Mar 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?
Impact of cellular infiltrate - Group 1 (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT01336270, 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 6 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.