Melanomahead neck-melNCT02883933
Clinical and Histological Features of Head and Neck Melanoma
An observational study of Melanoma, run by CHU de Reims at 1 site in France.
Trial summary
The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma
- What is being tested?
- Data collection
- How many people
- 1,548 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with melanoma.
Who may be able to join
- patients with melanoma
- melanoma diagnosed between January 2004 and December 2011
- patients living in Champagne-Ardenne
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.
Read the detailed description
Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.
- Conditions
- Melanoma
- Being tested
- Data collection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| melanoma | Patients with melanoma. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location of melanoma
Location of melanoma was classified in head and neck (scalp, forehead, temples, ears, neck, eyelids, nose, cheeks and area around mouse/chin) or other location (upper limb, lower limb, trunk, hand and foot).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJan 2004
- Primary completionDec 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,548 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883933
- Sponsor's protocol ID
- 2015Ao006
- Acronym
- head neck-mel
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
Publications
Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11.
PubMed 25333719
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Features of Head and Neck Melanoma
- ClinicalTrials.gov ID
- NCT02883933
- Acronym / sponsor ID
- head neck-mel / 2015Ao006
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,548 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 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.
The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.
Detailed description
Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| melanoma | – | Other: Data collectionPatients with melanoma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with melanoma.
Key inclusion criteria (3 listed)
- patients with melanoma
- melanoma diagnosed between January 2004 and December 2011
- patients living in Champagne-Ardenne
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Data collection | Other | melanoma |
Primary outcome
Location of melanoma
Time frame: Day 0
Location of melanoma was classified in head and neck (scalp, forehead, temples, ears, neck, eyelids, nose, cheeks and area around mouse/chin) or other location (upper limb, lower limb, trunk, hand and foot).
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 30 Aug 2016.
- Background: PubMed 25333719Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11.
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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?
An observational study of Melanoma, run by CHU de Reims 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 3 inclusion and 0 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 30 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?
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?
Location of melanoma (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883933, which also lists 1 linked publication.
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 30 Aug 2016.