NaeviNCT00862914
Immunohistochemical Expression Patterns of microRNA Processing Enzyme Dicer in Cutaneous Malignant Melanoma, Benign and Dysplastic Melanocytic Naevi
An observational study of Naevi and Malignant Melanoma, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Naevi, Malignant Melanoma
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Mar 2009
- 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: dermatologic primary care clinic
Who may be able to join
- Patients with benign melanocytic naevi, dysplastic melanocytic naevi and cutaneous malignant melanoma.
Who cannot join
- Patients under 18 years of age
- Patients with other forms of cancer in previous medical history
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology and Allergology, Ruhr-University Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study the researchers investigate the immunohistochemical distribution of Dicer in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma compared to intraindividual healthy control.
- Conditions
- Naevi, Malignant Melanoma
- Keywords
- Skin, MicroRNA, miRNA, Dicer, Malignant Melanoma
- Medical subject headings
- Nevus, Melanoma, Rhabdomyosarcoma, Embryonal, 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | benign melanocytic naevi | |
| 2 | dysplastic melanocytic naevi | |
| 3 | cutaneous malignant melanoma |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionMar 2009
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 NaeviStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sand, Ruhr University of Bochum
- Investigators
- Prof. Dr. Peter Altmeyer, Principal investigator, Department of Dermatology and Allergology, Ruhr-University BochumPD Dr. Falk G. Bechara, Study director, Department of Dermatology and Allergology, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862914
- Sponsor's protocol ID
- 006
- Status last verified
- Oct 2012
- First submitted
- 16 Mar 2009
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sand M, Gambichler T, Sand D, Altmeyer P, Stuecker M, Bechara FG. Immunohistochemical expression patterns of the microRNA-processing enzyme Dicer in cutaneous malignant melanomas, benign melanocytic nevi and dysplastic melanocytic nevi. Eur J Dermatol. 2011 Jan-Feb;21(1):18-21. doi: 10.1684/ejd.2011.1210.
PubMed 21262599
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunohistochemical Expression Patterns of microRNA Processing Enzyme Dicer in Cutaneous Malignant Melanoma, Benign and Dysplastic Melanocytic Naevi
- ClinicalTrials.gov ID
- NCT00862914
- Acronym / sponsor ID
- 006
- Conditions
- Naevi, Malignant Melanoma
- Keywords
- Skin, MicroRNA, miRNA, Dicer, Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Mar 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.
MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study the researchers investigate the immunohistochemical distribution of Dicer in benign and dysplastic melanocytic naevi as well as in cutaneous malignant melanoma compared to intraindividual healthy control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –benign melanocytic naevi |
| 2 | – | –dysplastic melanocytic naevi |
| 3 | – | –cutaneous malignant melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- dermatologic primary care clinic
Key inclusion criteria (1 listed)
- Patients with benign melanocytic naevi, dysplastic melanocytic naevi and cutaneous malignant melanoma.
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients with other forms of cancer in previous medical history
- Pregnancy
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
Not reported in the source record.
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 16 Oct 2012.
- Results publication: PubMed 21262599Sand M, Gambichler T, Sand D, Altmeyer P, Stuecker M, Bechara FG. Immunohistochemical expression patterns of the microRNA-processing enzyme Dicer in cutaneous malignant melanomas, benign melanocytic nevi and dysplastic melanocytic nevi. Eur J Dermatol. 2011 Jan-Feb;21(1):18-21. doi: 10.1684/ejd.2011.1210.
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LGCMN, Large and Giant Congenital Melanocytic Nevi
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
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The Cancer of the Pancreas Screening-5 CAPS5)Study
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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.
Prof. Dr. Peter Altmeyer principal investigator
Department of Dermatology and Allergology, Ruhr-University Bochum
PD Dr. Falk G. Bechara study director
Department of Dermatology and Allergology, Ruhr-University Bochum
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 Naevi and Malignant Melanoma, run by Ruhr University of Bochum at 1 site in Germany.
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 1 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 16 Oct 2012. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00862914, 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 16 Oct 2012.