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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Melanoma

Treatments

Procedure: Skin biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT04039672
69HCL19_0248

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Biopsy
Experimental group
Description:
Skin biopsy before BRAFi/MEKi treatment
Treatment:
Procedure: Skin biopsy

Trial contacts and locations

1

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Central trial contact

Stéphane DALLE, MD, Prof.

Data sourced from clinicaltrials.gov

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