Cutaneous Malignant MelanomaNCT01482260
Comparative Microarray Analysis in Primary Cutaneous Malignant Melanoma
An observational study of Cutaneous Malignant Melanoma, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cutaneous Malignant Melanoma
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Jan 2012
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with * Primary Cutaneous Malignant Melanoma * Cutaneous Malignant Melanoma Metastases * Benign Melanocytic Naevi
Who may be able to join
- Primary Cutaneous Malignant Melanoma
- Cutaneous Malignant Melanoma Metastases
- Benign Melanocytic Naevi
Who cannot join
- Other Skin Cancer than Primary Cutaneous Malignant Melanoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
Official title: Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.
Read the detailed description
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).
- Conditions
- Cutaneous Malignant Melanoma
- Being tested
- Biopsy
- Medical subject headings
- Melanoma, Cutaneous Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Primary Cutaneous Malignant Melanoma | Not described Receives: Procedure: Biopsy | |
| Cutaneous Malignant Melanoma Metastases | Not described Receives: Procedure: Biopsy | |
| Benign Melanocytic Nevi | Not described Receives: Procedure: Biopsy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2012
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 Cutaneous Malignant 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 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
- Falk G Bechara, PD Dr., Study director, Department of Dermatology, Venereology and Allergology, Ruhr-University BochumPeter Altmeyer, Prof. Dr., Study chair, Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482260
- Sponsor's protocol ID
- microRNA5
- Status last verified
- Nov 2012
- First submitted
- 26 Nov 2011
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sand M, Skrygan M, Sand D, Georgas D, Gambichler T, Hahn SA, Altmeyer P, Bechara FG. Comparative microarray analysis of microRNA expression profiles in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases, and benign melanocytic nevi. Cell Tissue Res. 2013 Jan;351(1):85-98. doi: 10.1007/s00441-012-1514-5. Epub 2012 Oct 31.
PubMed 23111773
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Microarray Analysis of microRNA Expression Profiles in Primary Cutaneous Malignant Melanoma, Cutaneous Malignant Melanoma Metastases and Benign Melanocytic Naevi
- ClinicalTrials.gov ID
- NCT01482260
- Acronym / sponsor ID
- microRNA5
- Conditions
- Cutaneous Malignant Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2012 (actual)
- First posted
- 30 Nov 2011 (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.
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). This study will be an exploratory analysis by miRNA expression profiling using microarrays.
Detailed description
Perturbations in microRNA (miRNA) expression profiles has been reported for cutaneous malignant melanoma (CMM). With regards to a rapidly growing number of newly discovered miRNA sequences, the availability of up-to-date miRNA expression profiles for primary cutaneous malignant melanoma (PCMM), cutaneous malignant melanoma metastases (CMMM) and benign melanocytic naevi (BMN) is limited. Patients with PCMM, CMMM and BMN are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Cutaneous Malignant Melanoma | – | Procedure: Biopsy |
| Cutaneous Malignant Melanoma Metastases | – | Procedure: Biopsy |
| Benign Melanocytic Nevi | – | Procedure: Biopsy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with * Primary Cutaneous Malignant Melanoma * Cutaneous Malignant Melanoma Metastases * Benign Melanocytic Naevi
Key inclusion criteria (3 listed)
- Primary Cutaneous Malignant Melanoma
- Cutaneous Malignant Melanoma Metastases
- Benign Melanocytic Naevi
Key exclusion criteria (1 listed)
- Other Skin Cancer than Primary Cutaneous Malignant Melanoma
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 |
|---|---|---|
| BiopsyBiopsy | Procedure or surgery | Benign Melanocytic Nevi, Cutaneous Malignant Melanoma Metastases, Primary Cutaneous Malignant Melanoma |
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 6 Nov 2012.
- Results publication: PubMed 23111773Sand M, Skrygan M, Sand D, Georgas D, Gambichler T, Hahn SA, Altmeyer P, Bechara FG. Comparative microarray analysis of microRNA expression profiles in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases, and benign melanocytic nevi. Cell Tissue Res. 2013 Jan;351(1):85-98. doi: 10.1007/s00441-012-1514-5. Epub 2012 Oct 31.
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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.
Falk G Bechara, PD Dr. study director
Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
Peter Altmeyer, Prof. Dr. study chair
Department of Dermatology, Venereology 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 Cutaneous 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 3 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: finished, as of the sponsor's last update on 6 Nov 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 NCT01482260, 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 6 Nov 2012.