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

NCT04039672 | Completed

• 1 other identifier: 69HCL19_0248
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Avian embryo

Outcome Measures

Primary Outcomes (2)

• Grafted avian embryo development

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

  2 days post graft

• Grafted avian embryo viability

  Survival rate of grafted embryo

  2 days post graft

Secondary Outcomes (12)

• BRAFi/MEKi maximum toxic effect dose in avian embryo

  3 months post treatment administration

• BRAFi maximum toxic effect dose in avian embryon

  3 months post treatment administration

• MEKi maximum toxic effect dose in avian embryo

  3 months post treatment administration

• BRAFi maximum toxic effect dose in avian embryo

  3 months post treatment administration

• MEKi maximum toxic effect dose in avian embryo

  3 months post treatment administration

Study Arms (1)

Biopsy

EXPERIMENTAL

Skin biopsy before BRAFi/MEKi treatment

Procedure: Skin biopsy

Interventions

Skin biopsy PROCEDURE

5mm skin metastasis or primary melanoma biopsy

Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Dermatologie, Centre hospitalier Lyon Sud, HCL

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: July 31, 2019
• Study Start: April 2, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-09

Locations

FR (1)