Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients (IMMUMELA)

This study is currently recruiting participants.
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01336270
First received: April 14, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Melanoma
Other: biological collection

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Impact of cellular infiltrate - Group 1 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Modifications of cellular infiltrate after chemotherapy (after 2 months)


Biospecimen Retention:   Samples With DNA

A bank of biological samples (human plasma and cells) will be done


Estimated Enrollment: 225
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MELANOMA 10mm
patients with a melanoma larger than 10mm or with cutaneous metastasis
Other: biological collection
to collect some human cell samples in melanoma
Other Name: to collect some human cell samples in melanoma
STAGE III MELANOMA
stage III melanoma patients who shall undergo a regional lymph node dissection
Other: biological collection
to collect some human cell samples in melanoma
Other Name: to collect some human cell samples in melanoma
SENTINEL NODE PROCEDURE
retrospective study of patients who underwent a sentinel node procedure
Other: biological collection
to collect some human cell samples in melanoma
Other Name: to collect some human cell samples in melanoma
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
Other: biological collection
to collect some human cell samples in melanoma
Other Name: to collect some human cell samples in melanoma

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))

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336270

Contacts
Contact: Marie Françoise Avril, MD, PhD +331 58 411781 marie-francoise.avril@cch.aphp.fr
Contact: Laurence Lecomte, PhD ++33171196494 laurence.lecomte@nck.aphp.fr

Locations
France
Cochin Hospital Recruiting
Paris, Ile de France, France, 75014
Contact: Marie Françoise Avril, MD, PhD    +331 58411781    marie-francoise.avril@cch.aphp.fr   
Contact: Laurence Lecomte, Phd    +33171196494    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Marie Françoise Avril, MD, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01336270     History of Changes
Other Study ID Numbers: P090405
Study First Received: April 14, 2011
Last Updated: July 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Melanoma
NK cells
T lymphocytes
macrophages

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014