Skin CancerNCT01010321

Confocal Microscopy of Benign and Malignant Skin Tumors

An observational study of Skin Cancer, run by Sheba Medical Center.

Suspended

Paused. Enrolment is on hold for now and may resume.

Trial summary

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skin Cancer
What is being tested?: confocal microscopy
Type of treatment: Medical device
How many people: 60 participants
Where: No sites listed yet
Study dates: Nov 2009to Nov 2010
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: Men and women over the age of 18 - Skin lesion suspected to either BCC,SCC etc

Who may be able to join

Men and women over the age of 18
Skin lesion suspected to either BCC or SCC etc
Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Who cannot join

Pregnant women
Children

About this study

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.

Conditions: Skin Cancer
Being tested: confocal microscopy
Keywords: skin lesion suspect as BCC or SCC or others
Medical subject headings: Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

confocal microscopyDevice
non-invasive imaging

Study groups in NCT01010321
Study group	Role	What they receive
all study Population		all Receives: Device: confocal microscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

efficacy of a confocal microscope as a diagnostic tool
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Nov 2010

First posted10 Nov 2009 (estimated)
Study startNov 2009
Primary completionNov 2010 (estimated)
Study completionNov 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Skin CancerStudies of the same condition, open and under way.
More trials run by Sheba Medical CenterThe 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: Case only
Time perspective: Prospective
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010321
Sponsor's protocol ID: SHEBA-09-7295-AB-CTIL
Status last verified: Jun 2010
First submitted: 2 Nov 2009
Last updated: 29 Jun 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer

All Skin Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Confocal Microscopy of Benign and Malignant Skin Tumors
ClinicalTrials.gov ID: NCT01010321
Acronym / sponsor ID: SHEBA-09-7295-AB-CTIL
Conditions: Skin Cancer
Keywords: skin lesion suspect as BCC or SCC or others
Study type: Observational
Recruitment status: Suspended
Enrolment: 60 participants (estimated)
Lead sponsor: Sheba Medical CenterOther government
Study start: Nov 2009
Primary completion: Nov 2010 (estimated)
Study completion: Nov 2010 (estimated)
First posted: 10 Nov 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.

The investigators speculate that this tool may be used as an alternative and convenient non-invasive diagnostic of skin cancer.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
all study Population	–	Device: confocal microscopyall

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Men and women over the age of 18 - Skin lesion suspected to either BCC,SCC etc

Key inclusion criteria (3 listed)

Men and women over the age of 18
Skin lesion suspected to either BCC or SCC etc
Patient was referred for biopsy diagnostic/therapeutic before hand, and regardless of confocal microscope examination, according to the clinical consideration of physician

Key exclusion criteria (2 listed)

Pregnant women
Children

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
confocal microscopynon-invasive imaging	Device	all study Population

Primary outcome

efficacy of a confocal microscope as a diagnostic tool
Time frame: 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.

Related trials for Skin Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer

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.

Aviv Barzilai, Dr. principal investigator

Sheba Medical Center

Questions about this trial

What is this clinical trial studying?

An observational study of Skin Cancer, run by Sheba Medical Center.

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 2 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: paused, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

efficacy of a confocal microscope as a diagnostic tool (time frame: 1 year). 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 NCT01010321.

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 29 Jun 2010.