MelanomaMELANOPREDICTNCT04039672
Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAFi/MEKi in BRAF Mutated Melanoma
A study testing Skin biopsy in people with Melanoma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2021to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Service de Dermatologie, Centre hospitalier Lyon Sud, HCL
Pierre-Bénite, 69495
About this study
Official title: 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.
- Conditions
- Melanoma
- Being tested
- Skin biopsy
- Keywords
- Melanoma, Avian embryo
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
5mm skin metastasis or primary melanoma biopsy
| Study group | Role | What they receive |
|---|---|---|
| Biopsy | Experimental | Skin biopsy before BRAFi/MEKi treatment Receives: Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grafted avian embryo development
Number of grafted embryo which develop tumor measurable by 3D microscopy
Measured: 2 days post graft
Grafted avian embryo viability
Survival rate of grafted embryo
Measured: 2 days post graft
Secondary outcomes (12)
BRAFi/MEKi maximum toxic effect dose in avian embryo
Survival rate in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryon
Survival rate in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
weight of avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Height of avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Height of avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Presence of cardiac malformation in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Presence of cardiac malformation in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Presence of craniofacial malformation in avian embryo after treatment injections in different concentrations
Measured: 3 months post treatment administration
Patient treatment response
RECIST 1.1 response
Measured: 3 months post inclusion
Embryo treatment response (tumor)
Embryo tumor volume obtained by confocal microscopy before treatment administration compared with tumor volume of non-treated embryo
Measured: 2 days post graft
Embryo treatment response (metastasis)
Metastasis appearance
Measured: 2 days post graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start2 Apr 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039672
- Sponsor's protocol ID
- 69HCL19_0248
- Acronym
- MELANOPREDICT
- Status last verified
- Sep 2024
- First submitted
- 15 May 2019
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Tumor Replicates in Avian Embryo to Model Therapeutic Effects of BRAF Inhibitors/MEK Inhibitors (BRAFi/MEKi) in BRAF Mutated Melanoma
- ClinicalTrials.gov ID
- NCT04039672
- Acronym / sponsor ID
- MELANOPREDICT / 69HCL19_0248
- Conditions
- Melanoma
- Keywords
- Melanoma, Avian embryo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy | Experimental | Procedure: Skin biopsySkin biopsy before BRAFi/MEKi treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsy5mm skin metastasis or primary melanoma biopsy | Procedure or surgery | Biopsy |
Primary outcome
Grafted avian embryo development
Time frame: 2 days post graft
Number of grafted embryo which develop tumor measurable by 3D microscopy
Grafted avian embryo viability
Time frame: 2 days post graft
Survival rate of grafted embryo
12 secondary outcomes
BRAFi/MEKi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryon
Time frame: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
BRAFi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
MEKi maximum toxic effect dose in avian embryo
Time frame: 3 months post treatment administration
Patient treatment response
Time frame: 3 months post inclusion
Embryo treatment response (tumor)
Time frame: 2 days post graft
Embryo treatment response (metastasis)
Time frame: 2 days post graft
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy in people with Melanoma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grafted avian embryo development (time frame: 2 days post graft). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.