Back to resultsNew Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy (SkinTher)
Primary Purpose
Melanoma (Skin)
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Development of the most specific physiologically relevant experimental patient models
Sponsored by
About this trial
This is an interventional other trial for Melanoma (Skin)
Eligibility Criteria
Inclusion Criteria:
- Major Patients,
- patients with melanoma (stage IV) with cutaneous metastases,
- seronegative HIV, HBV, HCV, HTLV1.
Exclusion Criteria:
- Absence of cutaneous metastasis or in transit
- HIV or HBV or HCV or HTLV1 seropositivity
- Patient minor, patient under guardianship or curatorship
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient with stage IV melanoma
Arm Description
Outcomes
Primary Outcome Measures
Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules
Secondary Outcome Measures
Full Information
NCT ID
NCT03136783
First Posted
April 28, 2017
Last Updated
April 28, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03136783
Brief Title
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
Acronym
SkinTher
Official Title
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
September 22, 2019 (Anticipated)
Study Completion Date
September 22, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).
Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.
The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with stage IV melanoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Development of the most specific physiologically relevant experimental patient models
Intervention Description
Development of the most specific physiologically relevant experimental patient models: organotypic culture of biopsies, reconstituted skin (equivalents of dermis with melanoma, dermis equivalents and epidermis with melanoma), and in vitro evaluation The response of tumor cells to different combinations of targeted therapy molecules
Primary Outcome Measure Information:
Title
Evaluating in vitro the response of tumor cells to different combinations of targeted therapy molecules
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major Patients,
patients with melanoma (stage IV) with cutaneous metastases,
seronegative HIV, HBV, HCV, HTLV1.
Exclusion Criteria:
Absence of cutaneous metastasis or in transit
HIV or HBV or HCV or HTLV1 seropositivity
Patient minor, patient under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine LOK-CHARLES, PhD
Phone
+33322455841
Email
lok.catherine@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine LOK-CHARLES, PhD
Phone
+33322455841
Email
lok.catherine@chu-amiens.fr
12. IPD Sharing Statement
Learn more about this trial
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
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