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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01336270
First received: April 14, 2011
Last updated: August 25, 2014
Last verified: August 2014
  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


Enrollment: 217
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336270

Locations
France
Cochin Hospital
Paris, Ile de France, France, 75014
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: August 25, 2014
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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014