Cutaneous Squamous Cell CarcinomaNCT01500954
Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma
An observational study of Cutaneous Squamous Cell Carcinoma, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Dec 2011
- 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 cutaneous squamous cell carcinoma
Who may be able to join
- cutaneous squamous cell carcinoma
Who cannot join
- other skin cancer than cutaneous squamous cell carcinoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, Ruhr-University Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far.
Read the detailed description
Patients with cutaneous SCC were enrolled in the present study. Tumor biopsies were taken from the center of the tumor. Adjacent healthy skin was biopsied as a control (intraindividual control). miRNA expression profiles of specimen were detected by microarray miRNA expression profiling. Microarray results were confirmed by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).
- Conditions
- Cutaneous Squamous Cell Carcinoma
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 |
|---|---|---|
| squamous cell carcinoma | Not described | |
| non-lesional skin | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Squamous Cell CarcinomaStudies 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
- 7 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, Dermatologic Surgery Unit, Ruhr-University BochumPeter Altmeyer, Prof. Dr., Study chair, Department of Dermatology, Venereology and Allergology, Ruhr-University BochumMichael Sand, Dr., Principal investigator, Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500954
- Sponsor's protocol ID
- microRNA7
- Status last verified
- Oct 2012
- First submitted
- 23 Dec 2011
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sand M, Skrygan M, Georgas D, Sand D, Hahn SA, Gambichler T, Altmeyer P, Bechara FG. Microarray analysis of microRNA expression in cutaneous squamous cell carcinoma. J Dermatol Sci. 2012 Dec;68(3):119-26. doi: 10.1016/j.jdermsci.2012.09.004. Epub 2012 Sep 13.
PubMed 23026055
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
- Microarray Analysis of microRNA Expression Profiles in Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01500954
- Acronym / sponsor ID
- microRNA7
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Dec 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.
MicroRNAs (miRNAs) are a novel class of short RNAs which have shown to be dysregulated in a variety of cancers. Data of miRNA expression in cutaneous squamous cell carcinoma (cSCC) is very limited and microarray based genome wide miRNA expression profiles of cSCC have not been investigated so far.
Detailed description
Patients with cutaneous SCC were enrolled in the present study. Tumor biopsies were taken from the center of the tumor. Adjacent healthy skin was biopsied as a control (intraindividual control). miRNA expression profiles of specimen were detected by microarray miRNA expression profiling. Microarray results were confirmed by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| squamous cell carcinoma | – | – |
| non-lesional skin | – | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cutaneous squamous cell carcinoma
Key inclusion criteria (1 listed)
- cutaneous squamous cell carcinoma
Key exclusion criteria (1 listed)
- other skin cancer than cutaneous squamous cell carcinoma
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 23026055Sand M, Skrygan M, Georgas D, Sand D, Hahn SA, Gambichler T, Altmeyer P, Bechara FG. Microarray analysis of microRNA expression in cutaneous squamous cell carcinoma. J Dermatol Sci. 2012 Dec;68(3):119-26. doi: 10.1016/j.jdermsci.2012.09.004. Epub 2012 Sep 13.
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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, Dermatologic Surgery Unit, Ruhr-University Bochum
Peter Altmeyer, Prof. Dr. study chair
Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
Michael Sand, Dr. principal investigator
Department of Dermatology, Venereology and Allergology, Dermatologic Surgery Unit, 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 Squamous Cell Carcinoma, 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 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 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 NCT01500954, 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.