MelanomaMelan-CohortNCT00839410
Multicentric Cohort of Melanoma Patients in Ile de France Area
An observational study of Melanoma and Genetic Polymorphism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Genetic Polymorphism
- How many people
- 1,255 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to Oct 2019
- 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: Adults with anatomo-pathologically proved melanoma
Who may be able to join
- age ≥ 18 years
- an informed consent is obtained
- patients with anatomy-pathologically proved melanoma
- the tissue sample of melanoma is available
- the primary melanoma is treated according to the international standard
- absence of a progressive non neoplastic pathology involving life-threatening
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- patient living in Ile de France region.
- time limit to entry in the cohort must be:
- within 3 months after Surgical resumption of primary melanoma;
- within 3 months after curative surgical treatment;
- with one month after diagnosis of a transit metastasis or a distant metastasis.
Who cannot join
- refusal of the patient
- pathology sample isn't available
- primary melanoma not being treated according to the international standard
- patient living too far to follow regular visits
- patient diagnosed with a progressive non neoplastic pathology involving life-threatening
- too late to entry and lack of useful stored specimens to research.
Trial locations and contacts
1 site in 1 country.
France1 site
Pr Philippe Saiag
Boulogne-Billancourt, Île-de-France Region, 92100
About this study
This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.
Read the detailed description
Melan-Cohort should constitute the first multicentric cohort with various objectives: prognostic, therapeutic, cognitive and medico-economical studies on melanoma. Patients will be recruited in all of the dermatology departments of APHP (dermatology departments from AMBROISE PARE, Saint-Louis, BICHAT-Claude Bernard,Henri-Mondor, Cochin-Tarnier, and Tenon hospitals). For all included patients, a standard file is filled comprising all anatomy-clinical useful data and epidemiologic ones, including sun exposures. Blood is harvested to collect DNA, RNA, serum, plasma at inclusion and at regular intervals and in case of progressive disease. Procedures for sentinel lymph node biopsies have been homogenized. An informed consent is obtained for each patient included in the cohort. A steering committee meets on a regular basis, and genetics or pathology subgroups have been constituted. An electronic CRF is available using the Intranet of APHP hospitals. Specimens are stored using high quality standards.
- Conditions
- Melanoma, Genetic Polymorphism
- Keywords
- skin cancer, melanoma, sentinel lymph node biopsy, bio bank, genetic polymorphism, prospective cohort, cohort, sentinel lymph nodes, tissue samples
- Medical subject headings
- Melanoma, Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (0-10 years) Disease free survival (0-10 years)
Measured: 10 years
Secondary outcomes (1)
Invasion of sentinel lymph node biopsy
Measured: 2003-2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startSep 2003
- Primary completionOct 2019
- Study completionOct 2019
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 Assistance Publique - Hôpitaux de ParisThe 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
- 1,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Saiag, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839410
- Sponsor's protocol ID
- P020927
- Acronym
- Melan-Cohort
- Status last verified
- Sep 2019
- First submitted
- 6 Feb 2009
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Cohort of Melanoma Patients in Ile de France Area
- ClinicalTrials.gov ID
- NCT00839410
- Acronym / sponsor ID
- Melan-Cohort / P020927
- Conditions
- Melanoma, Genetic Polymorphism
- Keywords
- skin cancer, melanoma, sentinel lymph node biopsy, bio bank, genetic polymorphism, prospective cohort, cohort, sentinel lymph nodes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,255 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2003 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 9 Feb 2009 (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.
This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.
Detailed description
Melan-Cohort should constitute the first multicentric cohort with various objectives: prognostic, therapeutic, cognitive and medico-economical studies on melanoma. Patients will be recruited in all of the dermatology departments of APHP (dermatology departments from AMBROISE PARE, Saint-Louis, BICHAT-Claude Bernard,Henri-Mondor, Cochin-Tarnier, and Tenon hospitals). For all included patients, a standard file is filled comprising all anatomy-clinical useful data and epidemiologic ones, including sun exposures. Blood is harvested to collect DNA, RNA, serum, plasma at inclusion and at regular intervals and in case of progressive disease. Procedures for sentinel lymph node biopsies have been homogenized. An informed consent is obtained for each patient included in the cohort. A steering committee meets on a regular basis, and genetics or pathology subgroups have been constituted. An electronic CRF is available using the Intranet of APHP hospitals. Specimens are stored using high quality standards.
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
- Adults with anatomo-pathologically proved melanoma
Key inclusion criteria (11 listed)
- age ≥ 18 years
- an informed consent is obtained
- patients with anatomy-pathologically proved melanoma
- the tissue sample of melanoma is available
- the primary melanoma is treated according to the international standard
Key exclusion criteria (6 listed)
- refusal of the patient
- pathology sample isn't available
- primary melanoma not being treated according to the international standard
- patient living too far to follow regular visits
- patient diagnosed with a progressive non neoplastic pathology involving life-threatening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (0-10 years) Disease free survival (0-10 years)
Time frame: 10 years
1 secondary outcome
Invasion of sentinel lymph node biopsy
Time frame: 2003-2009
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 4 Oct 2019.
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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.
Philippe Saiag, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 and Genetic Polymorphism, run by Assistance Publique - Hôpitaux de Paris 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 11 inclusion and 6 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 4 Oct 2019. 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?
Overall survival (0-10 years) Disease free survival (0-10 years) (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 4 Oct 2019.