Merkel CarcinomaNCT03518307
Epidemiology of Merkel Carcinomas in the Bas-Rhin
An observational study of Merkel Carcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Carcinoma
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to Sep 2018
- 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
- Adult, Older adult
Study population: Patients residing in the Bas-Rhin and diagnosed between 1983 and 2011 as having primitive Merkel arcinoma (topographic code C44 morphological code 8247/3)
Who may be able to join
- Age >18 years
- Diagnosis of primary Merkel carcinoma (topographic code C44 morphological code 8247/3)
- Diagnosis made between 1983 and 2011
- Patient residing in the Bas-Rhin at the date of diagnosis
- Patient who has given his consent for the use of his data for research purposes
Who cannot join
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Dermatologie
Strasbourg, 67091
Dan LIPSKER, MD, PhD, 33.3.88.11.61.79, dan.lipsker@chru-strasbourg.fr
Alice Kieny, MD, 33.3.88.11.61.79, Alice.KIENY@chru-strasbourg.fr
About this study
Official title: Epidemiology of Merkel Carcinomas in the Bas-Rhin From 1983 to 2011: General Population Study Based on the Bas-Rhin Cancer Registry
The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.
- Conditions
- Merkel Carcinoma
- Keywords
- Merkel carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of demographic, clinical, management (diagnostic and therapeutic) and survival data for patients with Merkel carcinoma in the Lower Rhine region
Measured: The period from from January 1st, 1983 to December 31st, 2011 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Sep 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan LIPSKER, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518307
- Sponsor's protocol ID
- 6840
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Merkel Carcinomas in the Bas-Rhin From 1983 to 2011: General Population Study Based on the Bas-Rhin Cancer Registry
- ClinicalTrials.gov ID
- NCT03518307
- Acronym / sponsor ID
- 6840
- Conditions
- Merkel Carcinoma
- Keywords
- Merkel carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 May 2018 (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.
The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients residing in the Bas-Rhin and diagnosed between 1983 and 2011 as having primitive Merkel arcinoma (topographic code C44 morphological code 8247/3)
Key inclusion criteria (5 listed)
- Age >18 years
- Diagnosis of primary Merkel carcinoma (topographic code C44 morphological code 8247/3)
- Diagnosis made between 1983 and 2011
- Patient residing in the Bas-Rhin at the date of diagnosis
- Patient who has given his consent for the use of his data for research purposes
Key exclusion criteria (1 listed)
- Refusal to participate in research
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
Retrospective study of demographic, clinical, management (diagnostic and therapeutic) and survival data for patients with Merkel carcinoma in the Lower Rhine region
Time frame: The period from from January 1st, 1983 to December 31st, 2011 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: No
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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.
Dan LIPSKER, MD, PhD principal investigator
University Hospital, Strasbourg, France
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 Merkel Carcinoma, run by University Hospital, Strasbourg, France 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 5 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 8 May 2018. 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 Dan LIPSKER, MD, PhD (33.3.88.11.61.79, dan.lipsker@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of demographic, clinical, management (diagnostic and therapeutic) and survival data for patients with Merkel carcinoma in the Lower Rhine region (time frame: The period from from January 1st, 1983 to December 31st, 2011 will be examined). 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 8 May 2018.