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Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma (MELANOPREDICT)

Primary Purpose

Melanoma

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Skin biopsy

About this trial

This is an interventional diagnostic trial for Melanoma focused on measuring Melanoma, Avian embryo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged ≥ 18 years
Signed written informed consent
Patient with BRAF V600 mutated metastatic or unresectable melanoma histologically confirmed
BRAFi/MEKi treatment indication
Patient with skin tumor (excluded face and skinfold) available for biopsy
Measurable disease as defined by RECIST v1.1 criteria
Patient affiliated to or a beneficiary of a social security category

Exclusion Criteria:

Ocular melanoma
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Pregnant or nursing (lactating) women
Patients protected by law

Sites / Locations

Service de Dermatologie, Centre hospitalier Lyon Sud, HCLRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biopsy

Arm Description

Skin biopsy before BRAFi/MEKi treatment

Outcomes

Primary Outcome Measures

Grafted avian embryo development

Number of grafted embryo which develop tumor measurable by 3D microscopy

Grafted avian embryo viability

Survival rate of grafted embryo

Secondary Outcome Measures

BRAFi/MEKi maximum toxic effect dose in avian embryo

Survival rate in avian embryo after treatment injections in different concentrations

BRAFi maximum toxic effect dose in avian embryon

Survival rate in avian embryo after treatment injections in different concentrations

MEKi maximum toxic effect dose in avian embryo

weight of avian embryo after treatment injections in different concentrations

BRAFi maximum toxic effect dose in avian embryo

Height of avian embryo after treatment injections in different concentrations

MEKi maximum toxic effect dose in avian embryo

Height of avian embryo after treatment injections in different concentrations

BRAFi maximum toxic effect dose in avian embryo

Presence of cardiac malformation in avian embryo after treatment injections in different concentrations

MEKi maximum toxic effect dose in avian embryo

Presence of cardiac malformation in avian embryo after treatment injections in different concentrations

BRAFi maximum toxic effect dose in avian embryo

Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations

MEKi maximum toxic effect dose in avian embryo

Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations

Patient treatment response

RECIST 1.1 response

Embryo treatment response (tumor)

Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo

Embryo treatment response (metastasis)

Metastasis appearance

Full Information

NCT ID

NCT04039672

First Posted

May 15, 2019

Last Updated

July 5, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04039672

Brief Title

Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma

Acronym

MELANOPREDICT

Official Title

Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 10, 2020 (Actual)

Primary Completion Date

February 10, 2023 (Anticipated)

Study Completion Date

February 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an interventional mono-centric study in patients with BRAF mutated metastatic melanoma treated with BRAF/MEK inhibitors. The aim of the study is to test the grafting of patient tumoral cells in avian embryo and develop a predictive in vivo model for patient treatment response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Melanoma, Avian embryo

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biopsy

Arm Type

Experimental

Arm Description

Skin biopsy before BRAFi/MEKi treatment

Intervention Type

Procedure

Intervention Name(s)

Skin biopsy

Intervention Description

5mm skin metastasis or primary melanoma biopsy

Primary Outcome Measure Information:

Title

Grafted avian embryo development

Description

Number of grafted embryo which develop tumor measurable by 3D microscopy

Time Frame

2 days post graft

Title

Grafted avian embryo viability

Description

Survival rate of grafted embryo

Time Frame

2 days post graft

Secondary Outcome Measure Information:

Title

BRAFi/MEKi maximum toxic effect dose in avian embryo

Description

Survival rate in avian embryo after treatment injections in different concentrations

Time Frame