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

October 8, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France, 69495
        • Service de Dermatologie, Centre hospitalier Lyon Sud, HCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biopsy
Skin biopsy before BRAFi/MEKi treatment
Procedure: Skin biopsy
5mm skin metastasis or primary melanoma biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grafted avian embryo development
Time Frame: 2 days post graft
Number of grafted embryo which develop tumor measurable by 3D microscopy
2 days post graft
Grafted avian embryo viability
Time Frame: 2 days post graft
Survival rate of grafted embryo
2 days post graft

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BRAFi/MEKi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Survival rate in avian embryo after treatment injections in different concentrations
3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryon
Time Frame: 3 months post treatment administration
Survival rate in avian embryo after treatment injections in different concentrations
3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
weight of avian embryo after treatment injections in different concentrations
3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Height of avian embryo after treatment injections in different concentrations
3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Height of avian embryo after treatment injections in different concentrations
3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Presence of cardiac malformation in avian embryo after treatment injections in different concentrations
3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Presence of cardiac malformation in avian embryo after treatment injections in different concentrations
3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time Frame: 3 months post treatment administration
Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
3 months post treatment administration
Patient treatment response
Time Frame: 3 months post inclusion
RECIST 1.1 response
3 months post inclusion
Embryo treatment response (tumor)
Time Frame: 2 days post graft
Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo
2 days post graft
Embryo treatment response (metastasis)
Time Frame: 2 days post graft
Metastasis appearance
2 days post graft

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Actual)

July 2, 2024

Study Completion (Actual)

July 2, 2024

Study Registration Dates

First Submitted

May 15, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 8, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0248

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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