Interest of Tumor Replicates in Avian Embryo to Model The... | NCT04039672

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

NCT04039672

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Oct 10, 2024Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Melanoma

Interventions

Skin biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2021Actual

Primary Completion Date

Jul 2, 2024Actual

Completion Date

Jul 2, 2024Actual

First Submitted Date

May 15, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2024

Last Update Posted Date

Oct 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biopsy	Experimental	Skin biopsy before BRAFi/MEKi treatment	Procedure: Skin biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Skin biopsy	Procedure	5mm skin metastasis or primary melanoma biopsy	Biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
BRAFi/MEKi maximum toxic effect dose in avian embryo	Survival rate in avian embryo after treatment injections in different concentrations	3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryon

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Dermatologie, Centre hospitalier Lyon Sud, HCL		Pierre-Bénite		69495	France

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided