Carcinoma, Basal CellB-OSSNCT02285790
One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy
A study testing Reflectance confocal microscopy, Punch biopsy and Surgical excision in people with Carcinoma, Basal Cell, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Reflectance confocal microscopy, Punch biopsy and Surgical excision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2015to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist
- Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate
- Patient is willing and able to give written informed consent
- BCC lesion is suitable for conventional surgical excision under local anesthetics
- BCC lesion is present since at least 1 month
Who cannot join
- BCC lesion in a high-risk location of the face (H-zone and ears)
- Contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
- Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons)
- Patients with basal cell nevus syndrome
- Patients treated with hedgehog inhibitor medication
- Patients with a history of hypersensitivity to and/ or a history of allergy to local anesthesia
- Unavailability within the following 6 weeks (for example due to holiday or sports)
- Patients not competent to understand the procedures involved
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Dutch Cancer Institute
Amsterdam, North Holland, 1066CX
Academic_Medical_Center
Amsterdam, North Holland, 1105AZ
About this study
Official title: Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial
The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma
Read the detailed description
Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCCs is becoming a major worldwide public health problem (1,11). Between 1973 and 2009, the European standardized rate quadrupled from 40 to 165 per 100,000 person-years for men and from 34 to 157 for women, most probably as a result of more intensive UV exposure (12). This is supported by previous published epidemiological literature indicating that ultraviolet radiation is an important risk factor for BCC with a significant increase among outdoor workers (13,14). Despite the low mortality from BCC, multiple and recurring tumors confer a high morbidity and considerable burden for health care providers and health budgets. Although BCC does not seem to have a high effect on patients' quality of life, patients suffering from BCC are definitely interested in efficacy, low recurrence rates and cosmetic outcome of their therapies.(15). Meanwhile resources available at hospitals have not increased proportionally and therefore optimizing effectiveness of present treatment modalities in daily dermatologic practice is mandatory (16).
Clinically, BCC are characterized by small, translucent, or pearly papules, with raised teleangiectatic edges (17) . Most of the BCC occur in sun-exposed skin of the head and neck area (18,19). Sensitivity and positive predictive value for the clinical diagnosing of BCC by dermatologists has been reported to be 95.4% and 85.9%, respectively (20). However, dividing between BCC subtypes is not always possible upon clinical assessment. To date, histological analysis of punch biopsy remains the golden standard to confirm the clinical diagnosis of BCCs and dividing between the following subtypes: nodular (nBCC), micronodular (mnBCC), infiltrating (iBCC) and superficial (sBCC) (10). Of those, nBCC and sBCC have a less aggressive growth pattern in comparison to mnBCC and iBCC. Additionally, mixed type BCC (mtBCC) can be defined as a combination of subtypes and are frequently composed of aggressive subtypes (21). Surgical excision remains the standard of treatment, with Mohs micrographic surgery typically utilized for high-risk lesions (22). Based upon the histological growth pattern, BCC are surgically removed with a margin of either 3mm (nBCC and sBCC) or 5mm (mnBCC, iBCC) in accordance with current Dutch guidelines (10).
Due to the rising incidence of BCC there is a need for more efficient, non-invasive methods to diagnose BCCs. The use of real-time in vivo reflectance confocal microscopy (RCM) to diagnose BCCs has proven successful to address this need. Various studies have demonstrated that RCM is safe and accurate (sensitivity and specificity) to diagnose BCCs(2-6). Reported sensitivity and specificity for RCM in diagnosing BCC range from 83%-100% and 79%-97%, respectively (7). Furthermore, Peppelman et al. and Longo et al. recently reported on RCM features that might divide between nodular, micronodular, superficial and infiltrative subtypes of BCC (8,9).
In 2012, van der Geer et al reported on the feasibility of a one-stop-shop (OSS) concept for the treatment of skin cancer patients (23). One-stop-shop implies that at the day of the initial outpatient clinic consultation, diagnosis and treatment plan both take place. In their study, pre-operative frozen section histology was used to confirm BCC diagnosis and subtype. The mean throughput time was 4 hours and 7 min, no complications were observed, and patient satisfaction was high (23). Incorporating RCM as non-invasive diagnostic tool in a BCC OSS concept for lesions suitable for conventional surgical excision might further reduce time between clinical diagnosis and treatment, administrative workload and costs.
The aim of our study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy (Vivascope 1500; Lucid Technologies, Henrietta, NY, USA) as diagnostic tool, prior to surgical management of new primary BCCs, of all subtypes, in the general population.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Reflectance confocal microscopy, Punch biopsy, Surgical excision
- 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.
Reflectance confocal microscopyDevice
Also called Confocal microscopy, Vivascope 1500
Punch biopsyProcedure or surgery
Also called Biopsy
Surgical excisionProcedure or surgery
Also called Surgical removal, Surgery
Excision of the suspected basal cell carcinoma lesion under local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| RCM-OSS procedure | Experimental | The Vivascope 1500 will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed for intended use only and interpreted on the Vivascope workstation by two investigators independently at both study locations. The investigators will be blinded to the results of the reference standard. After RCM imaging subjects will receive OSS surgical excision according to subtype. Clinically suspected primary BCCs that are not confirmed by RCM will also receive surgical treatment with a margin of 3mm. Receives: Device: Reflectance confocal microscopy; Procedure: Surgical excision |
| Standard of care procedure | Active comparator | Clinical suspected primary BCCs, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most elevated part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. HE stained sections of the punch biopsies will be evaluated by an experienced board certified pathologist. Subjects will receive surgical excision according to subtype within 6 weeks after punch biopsy has been performed. Clinically suspected new primary BCCs that are not confirmed by punch biopsy will also receive surgical treatment with a margin of 3mm. Receives: Procedure: Punch biopsy; Procedure: Surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report.
Assessment will be performed by an experienced board certified pathologist. The number of incomplete excisions will be compared between study- and control group.
Measured: Within the first week after surgical excision of suspected BCC lesion
Secondary outcomes (2)
Comparison of the diagnostic accuracy (sensitivity and specificity) between RCM and punch biopsy in both diagnosing and subtyping BCCs
Sensitivity and specificity of RCM for diagnosing and subtyping BCC, will be separately analyzed by comparing RCM diagnosis and subtype with final pathology reports of the study group. This will be performed by using unidentifiable saved RCM images of all included lesions of the study group.
Measured: Within the first week after surgical excision of suspected BCC lesion
Comparison of patient satisfaction between study group and standard of care (control) group by using a standardized web-based questionnaire for patient reported outcome in the management of skin diseases (www.huidvragen.info)
An adjusted version of this web-based questionnaire has previously been published to assess patient satisfaction among patients suffering from psoriasis (van Cranenburgh OD et al. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405). The outcome of the questionnaire will be compared between study- and control group.
Measured: As assessed at the post-operative visit 3 months after surgical excision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Principal investigator, Daniel Kadouch, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Menno A. de Rie, MD, PhD, Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285790
- Sponsor's protocol ID
- B-OSS 2014_244
- Acronym
- B-OSS
- Status last verified
- Apr 2016
- First submitted
- 1 Nov 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.
PubMed 22251204Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.
PubMed 12236882Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.
PubMed 12451371van der Geer S, Reijers HA, van Tuijl HF, de Vries H, Krekels GA. Need for a new skin cancer management strategy. Arch Dermatol. 2010 Mar;146(3):332-6. doi: 10.1001/archdermatol.2010.1.
PubMed 20231509van der Geer S, Frunt M, Romero HL, Dellaert NP, Jansen-Vullers MH, Demeyere TB, Neumann HA, Krekels GA. One-stop-shop treatment for basal cell carcinoma, part of a new disease management strategy. J Eur Acad Dermatol Venereol. 2012 Sep;26(9):1154-7. doi: 10.1111/j.1468-3083.2011.04184.x. Epub 2011 Jul 19.
PubMed 21771105van Cranenburgh OD, de Korte J, Sprangers MA, de Rie MA, Smets EM. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405. doi: 10.1111/bjd.12372.
PubMed 23565643Kadouch DJ, Wolkerstorfer A, Elshot Y, Zupan-Kajcovski B, Crijns MB, Starink MV, Bekkenk MW, van der Wal AC, Spuls PI, de Rie MA. Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2015 Sep 10;4(3):e109. doi: 10.2196/resprot.4303.
PubMed 26362616
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT02285790
- Acronym / sponsor ID
- B-OSS / B-OSS 2014_244
- Conditions
- Carcinoma, Basal Cell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Nov 2014 (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 purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma
Detailed description
Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCCs is becoming a major worldwide public health problem (1,11). Between 1973 and 2009, the European standardized rate quadrupled from 40 to 165 per 100,000 person-years for men and from 34 to 157 for women, most probably as a result of more intensive UV exposure (12). This is supported by previous published epidemiological literature indicating that ultraviolet radiation is an important risk factor for BCC with a significant increase among outdoor workers (13,14). Despite the low mortality from BCC, multiple and recurring tumors confer a high morbidity and considerable burden for health care providers and health budgets. Although BCC does not seem to have a high effect on patients' quality of life, patients suffering from BCC are definitely interested in efficacy, low recurrence rates and cosmetic outcome of their therapies.(15). Meanwhile resources available at hospitals have not increased proportionally and therefore optimizing effectiveness of present treatment modalities in daily dermatologic practice is mandatory (16).
Clinically, BCC are characterized by small, translucent, or pearly papules, with raised teleangiectatic edges (17) . Most of the BCC occur in sun-exposed skin of the head and neck area (18,19). Sensitivity and positive predictive value for the clinical diagnosing of BCC by dermatologists has been reported to be 95.4% and 85.9%, respectively (20). However, dividing between BCC subtypes is not always possible upon clinical assessment. To date, histological analysis of punch biopsy remains the golden standard to confirm the clinical diagnosis of BCCs and dividing between the following subtypes: nodular (nBCC), micronodular (mnBCC), infiltrating (iBCC) and superficial (sBCC) (10). Of those, nBCC and sBCC have a less aggressive growth pattern in comparison to mnBCC and iBCC. Additionally, mixed type BCC (mtBCC) can be defined as a combination of subtypes and are frequently composed of aggressive subtypes (21). Surgical excision remains the standard of treatment, with Mohs micrographic surgery typically utilized for high-risk lesions (22). Based upon the histological growth pattern, BCC are surgically removed with a margin of either 3mm (nBCC and sBCC) or 5mm (mnBCC, iBCC) in accordance with current Dutch guidelines (10).
Due to the rising incidence of BCC there is a need for more efficient, non-invasive methods to diagnose BCCs. The use of real-time in vivo reflectance confocal microscopy (RCM) to diagnose BCCs has proven successful to address this need. Various studies have demonstrated that RCM is safe and accurate (sensitivity and specificity) to diagnose BCCs(2-6). Reported sensitivity and specificity for RCM in diagnosing BCC range from 83%-100% and 79%-97%, respectively (7). Furthermore, Peppelman et al. and Longo et al. recently reported on RCM features that might divide between nodular, micronodular, superficial and infiltrative subtypes of BCC (8,9).
In 2012, van der Geer et al reported on the feasibility of a one-stop-shop (OSS) concept for the treatment of skin cancer patients (23). One-stop-shop implies that at the day of the initial outpatient clinic consultation, diagnosis and treatment plan both take place. In their study, pre-operative frozen section histology was used to confirm BCC diagnosis and subtype. The mean throughput time was 4 hours and 7 min, no complications were observed, and patient satisfaction was high (23). Incorporating RCM as non-invasive diagnostic tool in a BCC OSS concept for lesions suitable for conventional surgical excision might further reduce time between clinical diagnosis and treatment, administrative workload and costs.
The aim of our study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy (Vivascope 1500; Lucid Technologies, Henrietta, NY, USA) as diagnostic tool, prior to surgical management of new primary BCCs, of all subtypes, in the general population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCM-OSS procedure | Experimental | Device: Reflectance confocal microscopy, Procedure: Surgical excisionThe Vivascope 1500 will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed for intended use only and interpreted on the Vivascope workstation by two investigators independently at both study locations. The investigators will be blinded to the results of the reference standard. After RCM imaging subjects will receive OSS surgical excision according to subtype. Clinically suspected primary BCCs that are not confirmed by RCM will also receive surgical treatment with a margin of 3mm. |
| Standard of care procedure | Active comparator | Procedure: Punch biopsy, Procedure: Surgical excisionClinical suspected primary BCCs, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most elevated part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. HE stained sections of the punch biopsies will be evaluated by an experienced board certified pathologist. Subjects will receive surgical excision according to subtype within 6 weeks after punch biopsy has been performed. Clinically suspected new primary BCCs that are not confirmed by punch biopsy will also receive surgical treatment with a margin of 3mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist
- Patients seen at the outpatient clinic before 12h00 AM will be eligible to participate
- Patient is willing and able to give written informed consent
- BCC lesion is suitable for conventional surgical excision under local anesthetics
- BCC lesion is present since at least 1 month
Key exclusion criteria (8 listed)
- BCC lesion in a high-risk location of the face (H-zone and ears)
- Contra-indication for conventional surgical excision (primary surgical closure seems not achievable)
- Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons)
- Patients with basal cell nevus syndrome
- Patients treated with hedgehog inhibitor medication
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 |
|---|---|---|
| Reflectance confocal microscopyAlso: Confocal microscopy, Vivascope 1500 | Device | RCM-OSS procedure |
| Punch biopsyAlso: Biopsy | Procedure or surgery | Standard of care procedure |
| Surgical excisionAlso: Surgical removal, SurgeryExcision of the suspected basal cell carcinoma lesion under local anesthetics | Procedure or surgery | RCM-OSS procedure, Standard of care procedure |
Primary outcome
Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report.
Time frame: Within the first week after surgical excision of suspected BCC lesion
Assessment will be performed by an experienced board certified pathologist. The number of incomplete excisions will be compared between study- and control group.
2 secondary outcomes
Comparison of the diagnostic accuracy (sensitivity and specificity) between RCM and punch biopsy in both diagnosing and subtyping BCCs
Time frame: Within the first week after surgical excision of suspected BCC lesion
Comparison of patient satisfaction between study group and standard of care (control) group by using a standardized web-based questionnaire for patient reported outcome in the management of skin diseases (www.huidvragen.info)
Time frame: As assessed at the post-operative visit 3 months after surgical excision
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 13 Apr 2016.
- Background: PubMed 22251204Lomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x.
- Background: PubMed 12236882Sauermann K, Gambichler T, Wilmert M, Rotterdam S, Stucker M, Altmeyer P, Hoffmann K. Investigation of basal cell carcinoma [correction of carcionoma] by confocal laser scanning microscopy in vivo. Skin Res Technol. 2002 Aug;8(3):141-7. doi: 10.1034/j.1600-0846.2002.20345.x.
- Background: PubMed 12451371Gonzalez S, Tannous Z. Real-time, in vivo confocal reflectance microscopy of basal cell carcinoma. J Am Acad Dermatol. 2002 Dec;47(6):869-74. doi: 10.1067/mjd.2002.124690.
- Background: PubMed 20231509van der Geer S, Reijers HA, van Tuijl HF, de Vries H, Krekels GA. Need for a new skin cancer management strategy. Arch Dermatol. 2010 Mar;146(3):332-6. doi: 10.1001/archdermatol.2010.1.
- Background: PubMed 21771105van der Geer S, Frunt M, Romero HL, Dellaert NP, Jansen-Vullers MH, Demeyere TB, Neumann HA, Krekels GA. One-stop-shop treatment for basal cell carcinoma, part of a new disease management strategy. J Eur Acad Dermatol Venereol. 2012 Sep;26(9):1154-7. doi: 10.1111/j.1468-3083.2011.04184.x. Epub 2011 Jul 19.
- Background: PubMed 23565643van Cranenburgh OD, de Korte J, Sprangers MA, de Rie MA, Smets EM. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405. doi: 10.1111/bjd.12372.
- Derived from this study: PubMed 26362616Kadouch DJ, Wolkerstorfer A, Elshot Y, Zupan-Kajcovski B, Crijns MB, Starink MV, Bekkenk MW, van der Wal AC, Spuls PI, de Rie MA. Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2015 Sep 10;4(3):e109. doi: 10.2196/resprot.4303.
- Kadouch et al., In vivo confocal microscopy of basal cell carcinoma: a systematic review of diagnostic accuracy. PROSPERO 2014:CRD42014010379Link provided by the sponsor.
Related trials for Carcinoma, Basal Cell
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
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.
Menno A. de Rie, MD, PhD principal investigator
Head of Department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflectance confocal microscopy, Punch biopsy and Surgical excision in people with Carcinoma, Basal Cell, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
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 5 inclusion and 8 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
What does the primary outcome measure?
Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (time frame: Within the first week after surgical excision of suspected BCC lesion). 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 NCT02285790, which also lists 7 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 13 Apr 2016.