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

NCT ID: NCT04039672

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2024-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Biopsy

Skin biopsy before BRAFi/MEKi treatment

Group Type EXPERIMENTAL

Skin biopsy

Intervention Type PROCEDURE

5mm skin metastasis or primary melanoma biopsy

Interventions

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Skin biopsy

5mm skin metastasis or primary melanoma biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Dermatologie, Centre hospitalier Lyon Sud, HCL

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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69HCL19_0248

Identifier Type: -

Identifier Source: org_study_id

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