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

Melanoma Clinical Trial

— IMMUMELA  

Official title:

Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336270
• Other study ID #: P090405
• Status: Completed
• Phase: N/A
• First received: April 14, 2011
• Last updated: August 25, 2014
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• biological collection
to collect some human cell samples in melanoma

Locations

Country	Name	City	State
France	Cochin Hospital	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of cellular infiltrate - Group 1	Impact of cellular infiltrate on disease free survival at 2 years	2 years	No
Primary	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	2 and 3 years	No
Primary	Modifications of cellular infiltrate - Group 4	Modifications of cellular infiltrate after chemotherapy (after 2 months)	2 months	No