Malignant MelanomaMPGNCT04217382
Pre Transplantation Melanoma
An observational study of Malignant Melanoma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma. There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- patient with melanoma pre transplantation
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2020to 31 Aug 2020
- Phase
- Observational
- 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
Study population: patient with an antecedent of melanoma before transplantation
Who may be able to join
- patient with an antecedent of melanoma before transplantation
- Not opposite to participate
Who cannot join
- Under the age of 18
- patient under Guardianship
- patient not affiliated with a health system
Trial locations and contacts
1 site in 1 country.
France1 site
service de dermatologie - hopital Edouard Herriot
Lyon, Rhone, 69003
About this study
Official title: Pre Transplantation Melanoma : Retrospective and Prospective Multicenter Observational Study
Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma.
There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet.
Main objective is survival time without melanoma recurrence in this population to do guideline of time limit or not between melanoma and transplantation by stage.
- Conditions
- Malignant Melanoma
- Being tested
- patient with melanoma pre transplantation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient with melanoma pre transplantationOther
survival time without melanoma recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
survival time without melanoma recurrence
Delay in recurrence-free survival since diagnosis and since transplantation
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start27 Feb 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie DUCROUX, MD, Principal investigator, Service de Dermatologie, Hôpital Edouard Herriot, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217382
- Sponsor's protocol ID
- 69HCL19_0636
- Acronym
- MPG
- Status last verified
- Dec 2021
- First submitted
- 30 Dec 2019
- Last updated
- 10 Dec 2021
- 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 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre Transplantation Melanoma : Retrospective and Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT04217382
- Acronym / sponsor ID
- MPG / 69HCL19_0636
- Conditions
- Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Jan 2020 (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.
Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma.
There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet.
Main objective is survival time without melanoma recurrence in this population to do guideline of time limit or not between melanoma and transplantation by stage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with an antecedent of melanoma before transplantation
Key inclusion criteria (2 listed)
- patient with an antecedent of melanoma before transplantation
- Not opposite to participate
Key exclusion criteria (3 listed)
- Under the age of 18
- patient under Guardianship
- patient not affiliated with a health system
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 |
|---|---|---|
| patient with melanoma pre transplantationsurvival time without melanoma recurrence | Other | – |
Primary outcome
survival time without melanoma recurrence
Time frame: at enrollment
Delay in recurrence-free survival since diagnosis and since transplantation
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 Dec 2021.
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RecruitingPhase 1/2
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
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RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
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.
Emilie DUCROUX, MD principal investigator
Service de Dermatologie, Hôpital Edouard Herriot, Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant 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 2 inclusion and 3 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 Dec 2021. 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?
survival time without melanoma recurrence (time frame: at enrollment). 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 Dec 2021.