Basal Cell Carcinoma (BCC)NCT01633515
Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study
A study testing Intralesional cryotherapy in people with Basal Cell Carcinoma (BCC), run by Carmel Medical Center at 1 site in Israel.
Trial summary
A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery. 10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Basal Cell Carcinoma (BCC)
- What is being tested?
- Intralesional cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jul 2014
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 60 years old
- BCC was determined with tissue diagnosis in the lower extremity
- One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.
Who cannot join
- Patient unable to read, understand and sign the consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study
A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
Read the detailed description
BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.
surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.
- Conditions
- Basal Cell Carcinoma (BCC)
- Being tested
- Intralesional cryotherapy
- Keywords
- Basal cell carcinoma (BCC), Cryotherapy, Cryosurgery
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional cryotherapyProcedure or surgery
Also called CryoShape; CryoShape™, FDA 510(k) Number K060928)
The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn.
Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).
| Study group | Role | What they receive |
|---|---|---|
| Intralesional cryotherapy | Other | 10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications. Receives: Procedure: Intralesional cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly
Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate
Measured: Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Basal Cell Carcinoma (BCC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaron Har-Shai, Carmel Medical Center
- Investigators
- Yaron Har-Shai, M.D, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633515
- Sponsor's protocol ID
- EMC-12-0032-CTIL
- Status last verified
- Dec 2013
- First submitted
- 9 Jun 2012
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Har-Shai Y, Brown W, Pallua N, Zouboulis CC. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids. Plast Reconstr Surg. 2010 Nov;126(5):1798-1800. doi: 10.1097/PRS.0b013e3181ef823d. No abstract available.
PubMed 21042160Har-Shai Y, Brown W, Labbe D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds. 2008 Sep;7(3):169-75. doi: 10.1177/1534734608322813.
PubMed 18757392Giuffrida TJ, Jimenez G, Nouri K. Histologic cure of basal cell carcinoma treated with cryosurgery. J Am Acad Dermatol. 2003 Sep;49(3):483-6. doi: 10.1067/s0190-9622(03)00903-4.
PubMed 12963913
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01633515
- Acronym / sponsor ID
- EMC-12-0032-CTIL
- Conditions
- Basal Cell Carcinoma (BCC)
- Keywords
- Basal cell carcinoma (BCC), Cryotherapy, Cryosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 4 Jul 2012 (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.
A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment
Detailed description
BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.
surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.
10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intralesional cryotherapy | Other | Procedure: Intralesional cryotherapy10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 60 years old
- BCC was determined with tissue diagnosis in the lower extremity
- One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.
Key exclusion criteria (1 listed)
- Patient unable to read, understand and sign the consent form
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 |
|---|---|---|
| Intralesional cryotherapyAlso: CryoShape; CryoShape™, FDA 510(k) Number K060928)The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn. Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received). | Procedure or surgery | Intralesional cryotherapy |
Primary outcome
Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly
Time frame: Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).
Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Background: PubMed 21042160Har-Shai Y, Brown W, Pallua N, Zouboulis CC. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids. Plast Reconstr Surg. 2010 Nov;126(5):1798-1800. doi: 10.1097/PRS.0b013e3181ef823d. No abstract available.
- Background: PubMed 18757392Har-Shai Y, Brown W, Labbe D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds. 2008 Sep;7(3):169-75. doi: 10.1177/1534734608322813.
- Background: PubMed 12963913Giuffrida TJ, Jimenez G, Nouri K. Histologic cure of basal cell carcinoma treated with cryosurgery. J Am Acad Dermatol. 2003 Sep;49(3):483-6. doi: 10.1067/s0190-9622(03)00903-4.
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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.
Yaron Har-Shai, M.D principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional cryotherapy in people with Basal Cell Carcinoma (BCC), run by Carmel 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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2013. 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 Yaron har-Shai, M.D (972057866206, yaron07@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly (time frame: Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).). 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 NCT01633515, which also lists 3 linked publications.
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 3 Dec 2013.