Squamous Cell CarcinomaNCT03092830
Molecular Characterization of Cutaneous Tumors
An observational study of Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The objective is to find genes which are responsible for the appearance of skin tumors (sCC, BCC) and it will be the basis for prediction of the disease and response to the treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Basal Cell Carcinoma
- What is being tested?
- Molecular testing of DNA/RNA from skin tumors, SCC/BCC
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Mar 2017to 7 Aug 2020
- 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: above 18 years old with Scc and BCC skin tumors not pregnant women and no children or any person without judgment ability
Who may be able to join
- patient that have sCC and BCC tumors
- above 18 years old
Who cannot join
- below 18 years old
- pregnant women
- children or person without judgment ability
Trial locations and contacts
1 site in 1 country.
DR Asaf Olshinka, MD contact
Israel1 site, 1 recruiting
- Recruiting
RabinMC
Petah Tikva, 49100
DEAN AD EL, MD, 972-3-9377377, deana@clalit.org.il
SHARONA BEN AMI, MA, 972-3-9377377, sharonabe@clalit.org.il
About this study
The objective is to find genes which are responsible for the appearance of skin tumors (sCC, BCC) and it will be the basis for prediction of the disease and response to the treatment
Read the detailed description
Prospective, 1-arm, 500 participates above 18 age with skin tumor affliction sCC and BCC type.
- Conditions
- Squamous Cell Carcinoma, Basal Cell Carcinoma
- Being tested
- Molecular testing of DNA/RNA from skin tumors, SCC/BCC
- Keywords
- SCC, BCC, DNA, RNA, HEDGE HOG, epidermal growth factor receptor
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular testing of DNA/RNA from skin tumors, SCC/BCCGenetic
Molecular testing of DNA/RNA from skin tumors, SCC/BCC
| Study group | Role | What they receive |
|---|---|---|
| 1-arm, 500 participates | Molecular testing of DNA/RNA from skin tumors, SCC/BCC Receives: Genetic: Molecular testing of DNA/RNA from skin tumors, SCC/BCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Characterization of cutaneous tumors
samples from subjects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start29 Mar 2017
- Primary completion7 Aug 2020 (estimated)
- Study completion7 Aug 2020 (estimated)
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 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DR Dean Ad EL, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092830
- Sponsor's protocol ID
- 0515-15-RMC
- Status last verified
- Apr 2019
- First submitted
- 22 Mar 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winder M, Viros A. Mechanisms of Drug Resistance in Melanoma. Handb Exp Pharmacol. 2018;249:91-108. doi: 10.1007/164_2017_17.
PubMed 28275910
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Cutaneous Tumors
- ClinicalTrials.gov ID
- NCT03092830
- Acronym / sponsor ID
- 0515-15-RMC
- Conditions
- Squamous Cell Carcinoma, Basal Cell Carcinoma
- Keywords
- SCC, BCC, DNA, RNA, HEDGE HOG, epidermal growth factor receptor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 7 Aug 2020 (estimated)
- Study completion
- 7 Aug 2020 (estimated)
- First posted
- 28 Mar 2017 (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 objective is to find genes which are responsible for the appearance of skin tumors (sCC, BCC) and it will be the basis for prediction of the disease and response to the treatment
Detailed description
Prospective, 1-arm, 500 participates above 18 age with skin tumor affliction sCC and BCC type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-arm, 500 participates | – | Genetic: Molecular testing of DNA/RNA from skin tumors, SCC/BCCMolecular testing of DNA/RNA from skin tumors, SCC/BCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- above 18 years old with Scc and BCC skin tumors not pregnant women and no children or any person without judgment ability
Key inclusion criteria (2 listed)
- patient that have sCC and BCC tumors
- above 18 years old
Key exclusion criteria (3 listed)
- below 18 years old
- pregnant women
- children or person without judgment ability
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 |
|---|---|---|
| Molecular testing of DNA/RNA from skin tumors, SCC/BCCMolecular testing of DNA/RNA from skin tumors, SCC/BCC | Genetic | 1-arm, 500 participates |
Primary outcome
Molecular Characterization of cutaneous tumors
Time frame: 5 years
samples from subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 28275910Winder M, Viros A. Mechanisms of Drug Resistance in Melanoma. Handb Exp Pharmacol. 2018;249:91-108. doi: 10.1007/164_2017_17.
- 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.
DR Asaf Olshinka, MD contact
DR Dean Ad EL, MD principal investigator
Rabin Medical Center
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 Squamous Cell Carcinoma and Basal Cell Carcinoma, run by Rabin Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2019. 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 Israel. 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 DR Dean Ad EL, MD (+972-3-9376366, deana@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Characterization of cutaneous tumors (time frame: 5 years). 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 NCT03092830, 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 Apr 2019.