MelanomaNCT02884362
Prospective Melanoma Database
An observational study of Melanoma, run by Institut Claudius Regaud at 1 site in France.
Trial summary
In research on melanoma, translational research is the essential link between basic research and clinical research by facilitating the passage between discovery and improvement in the quality of patients care.That is the reason why it is very important to collect, and centralize clinical and biological data of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- clinical biological data collection on melanoma
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jun 2026
- 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: Patients with any histological type of melanoma and of any stage
Who may be able to join
- Age > 18 years
- Histologically confirmed melanoma of any stage
- Affiliated to a social security system in france
- Who signed the informed consent
Who cannot join
- Any psychiatric or medical condition that would make the patient unable to give a signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut claudius regaud IUCT ONCOPOLE
Toulouse, 31059
Nicolas MEYER, MD PHD, 5 31 15 51 61 ext. 33, Meyer.Nicolas@iuct-oncopole.fr
About this study
Official title: Creation of a Prospective Melanoma Database
In research on melanoma, translational research is the essential link between basic research and clinical research by facilitating the passage between discovery and improvement in the quality of patients care.That is the reason why it is very important to collect, and centralize clinical and biological data of patients with melanoma.
The aim of the project is to provide to scientific community a structured, mixed clinical and biological database, unique in France, in order to insure accessibility to clinical data.
Read the detailed description
collection of clinical and biological data from patients with melanomas of any stage in a structured and centralized database
- Conditions
- Melanoma
- Being tested
- clinical biological data collection on melanoma
- Keywords
- melanoma clinical biological database
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical biological data collection on melanomaOther
collection and centralization of clinical and biological data of patients with melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of patients with melanoma
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
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.
- 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
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MEYER, MD PHD, Principal investigator, Institut claudius regaud Toulouse ONCOPOLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884362
- Sponsor's protocol ID
- 16HLCUTA01
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Prospective Melanoma Database
- ClinicalTrials.gov ID
- NCT02884362
- Acronym / sponsor ID
- 16HLCUTA01
- Conditions
- Melanoma
- Keywords
- melanoma clinical biological database
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- 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.
In research on melanoma, translational research is the essential link between basic research and clinical research by facilitating the passage between discovery and improvement in the quality of patients care.That is the reason why it is very important to collect, and centralize clinical and biological data of patients with melanoma.
The aim of the project is to provide to scientific community a structured, mixed clinical and biological database, unique in France, in order to insure accessibility to clinical data.
Detailed description
collection of clinical and biological data from patients with melanomas of any stage in a structured and centralized database
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any histological type of melanoma and of any stage
Key inclusion criteria (4 listed)
- Age > 18 years
- Histologically confirmed melanoma of any stage
- Affiliated to a social security system in france
- Who signed the informed consent
Key exclusion criteria (1 listed)
- Any psychiatric or medical condition that would make the patient unable to give a signed informed consent
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 |
|---|---|---|
| clinical biological data collection on melanomacollection and centralization of clinical and biological data of patients with melanoma | Other | – |
Primary outcome
Database of patients with melanoma
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Nicolas MEYER, MD PHD principal investigator
Institut claudius regaud Toulouse ONCOPOLE
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 Melanoma, run by Institut Claudius Regaud 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas MEYER, MD PHD (5 31 15 51 61 ext. 33, Meyer.Nicolas@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database of patients with melanoma (time frame: 10 years). 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 31 Aug 2016.