Carcinoma, Basal CellNCT02623101
Reflectance Confocal Microscopy in Basal Cell Carcinoma
A study testing Reflectance confocal microscopy, Punch biopsy and Surgical excision in people with Carcinoma, Basal Cell, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. 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
- 288 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Dec 2015to 31 May 2019
- 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 must be able to adhere to all requirements of the study
- Patients must be willing to give written informed consent
- Clinically diagnosed/ clinical suspicion of basal cell carcinoma
Who cannot join
- Participating in other investigational research currently or in the previous 28 days before the study
- Patient is having a medical condition which excludes participating the research, according to the investigator
- Incapacitated subjects will not be included
- Lesion(s) on parts of the body which do not allow to adequately image the tumour with RCM.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Canisius Wilhelmina Hospital
Nijmegen
Radboud University Medical Center
Nijmegen
Rijnstate Hospital
Velp
About this study
Official title: In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.
Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.
Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.
Read the detailed description
INTRODUCTION AND RATIONALE:
Skin cancer is the most common cancer and its incidence is increasing rapidly in Western countries. In the Netherlands the registry of skin cancer is poor, however based on recent literature and guidelines the investigators estimate the number of new malignant skin tumors and the precursor actinic keratosis (AK) in 2015 at around 235,278, having a major impact on the health care system. Moreover, it is predicted that numbers of skin cancer will rise with 4.5-8% per year, depending on the type of skin cancer. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). In case of suspicion on NMSC, at present, the pathological examination of a biopsy is the gold standard. In case of clinical suspicion on AK, the diagnosis is made à vue, without pathological confirmation. In the United States, already in 2003, skin cancer was found to be among the most costly of all cancers to treat, thus, it is evident that skin cancer places an enormous burden on western healthcare systems with increasing costs. As BCC is the most common skin cancer (about 75% of all skin cancers) with an estimated incidence of 51,000 new tumors in 2015, this study will focus on this skin cancer type.
HEALTH CARE EFFICIENCY PROBLEM:
As described above, the incidences of the various malignant skin tumours are increasing dramatically. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. With the implementation of reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis is assessed at the first consultation and the patient can be treated instantly. A second consultation for explaining the diagnosis is than not necessary, which time can then be used for other new patients. Also, with the conventional diagnostic procedure (pathological investigation of a skin biopsy) the investigators experience in 29% of the cases a sample error, so the BCC subtype is not correctly identified, and as treatment depends on BCC subtype many patients need a subsequent treatment because of treatment failure or recurrence. Also for pathologists, to examine skin tumor after skin tumor is not that efficient and challenging. More pathologists are needed if there will not be other diagnostic techniques in the future. RCM will also, not unimportantly, lower the costs for diagnosing skin cancer.
USUAL CARE:
Currently, in case of suspicion on NMSC, including BCC, an invasive diagnostic biopsy for pathological examination is performed.Treatment choices depend on BCC subtype.
THE INTERVENTION TO BE INVESTIGATED:
RCM is a non-invasive imaging technique. It provides real time images of cell- and tissue structures and dynamics in situ, without the need for ex vivo tissue samples. RCM visualizes human skin up to a depth of around 250 μm. Most, but not all tumors can be visualized. For thicker tumors RCM may help to find the optimal localization to perform a biopsy, as superficial features in these tumors may help to spot these. Moreover, the whole tumor can be imaged by RCM and a diagnosis can be made instantly.
RCM features for skin cancer are reported, which showed a high correlation with conventional pathological features. These features allow to diagnose AK and SCC, and subtypes in BCC (superficial, nodular, micronodular, infiltrative and mixed type BCCs).
RCM in the RELEVANCE FOR PRACTICE
Skin cancer is responsible for 50% of the costs in dermatological patient care, 75-80% of these costs are caused by BCC. These costs will increase even more, as incidence rates will rise further. As described above, the gold standard is pathological investigation of a biopsy or of an excision. However, pathological diagnosis of a biopsy often results in sampling errors, as only a small part of the tumor is investigated resulting in potentially inappropriate chosen therapies. The subtypes of BCC are treated differently. As a sample error may lead to treatment failures or recurrences, other subsequent treatments are needed, increasing costs. In addition, the conventional method is unfriendly for patients, as it is invasive, painful, scarring, and the diagnosis is not instantly available. In order to implement patient friendly RCM in daily BCC care, a large prospective study is needed. The ability of RCM in determining the correct diagnosis and subtyping BCC needs to be investigated as well as preparing protocols for use in patient care. It is believed that this diagnostic imaging technique will be more cost-effective and more patient friendly as compared to the biopsy procedure, the gold standard at present. Therefore, the purpose of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.
Study design: Randomized controlled trail. Comparison with usual care; punch biopsy and excision.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Reflectance confocal microscopy, Punch biopsy, Surgical excision
- Keywords
- Reflectance confocal microscopy, Basal cell carcinoma, Biopsy, Diagnostics
- 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, Vivascope 3000
Non-invasive imaging of the lesion
Punch biopsyProcedure or surgery
Also called Biopsy
Obtaining a skin sample of the suspicious lesion under local anesthetics
Surgical excisionProcedure or surgery
Also called Surgical removal, Surgery
Excision of the basal cell carcinoma lesion under local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Standard of care procedure | Active comparator | Clinical suspected basal cell carcinomas, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most clinical suspicious part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. Hematoxylin/eosin stained sections of the punch biopsies will be evaluated by an experienced pathologist. Subjects will receive surgical excision according to subtype.
When there is any doubt by reflectance confocal microscopic diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma. Receives: Procedure: Punch biopsy; Procedure: Surgical excision |
| Reflectance confocal microscopy (RCM) | Experimental | The Vivascope 1500 and Vivascope 3000 (handheld divice) will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed on clinical suspected basal cell carcinomas, of all subtypes. When there are signs of a basal cell carcinoma imaged by RCM, subjects will receive surgical excision according to subtype. When there is any doubt by RCM diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma. Receives: Device: Reflectance confocal microscopy; Procedure: Surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen
Measured: Through study completion, an average of 3 years
Secondary outcomes (3)
Quality of life (Qol)
VAS (Visual analogue scale)
Measured: Through study completion, an average of 3 years
Cost effectiveness of Reflectance confocal microscopy as diagnostic tool to diagnose basal cell carcinoma
Productivity Cost Questionnaire (IMCQ, generic instrument for measuring medical costs)
Measured: Through study completion, an average of 3 years
Quality Adjusted Live Years (QALY's)
EQ-5D-5L health questionnaire
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 Radboud University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Mavig GmbH
- Responsible party
- Sponsor
- Investigators
- M JP Gerritsen, MD, PhD, Principal investigator, Radboud University Medical Center, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623101
- Sponsor's protocol ID
- RCM-onco ZonMw-1
- Status last verified
- Apr 2018
- First submitted
- 10 Nov 2015
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Flohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T. Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol. 2011 Jan;91(1):24-30. doi: 10.2340/00015555-1009.
PubMed 21264452Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013 Aug;133(8):1971-8. doi: 10.1038/jid.2013.134. Epub 2013 Mar 19.
PubMed 23510990Housman TS, Feldman SR, Williford PM, Fleischer AB Jr, Goldman ND, Acostamadiedo JM, Chen GJ. Skin cancer is among the most costly of all cancers to treat for the Medicare population. J Am Acad Dermatol. 2003 Mar;48(3):425-9. doi: 10.1067/mjd.2003.186.
PubMed 12637924Wolberink EA, Pasch MC, Zeiler M, van Erp PE, Gerritsen MJ. High discordance between punch biopsy and excision in establishing basal cell carcinoma subtype: analysis of 500 cases. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):985-9. doi: 10.1111/j.1468-3083.2012.04628.x. Epub 2012 Jul 3.
PubMed 22759209Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.
PubMed 24158236Peppelman M, Wolberink EA, Koopman RJ, van Erp PE, Gerritsen MJ. In vivo Reflectance Confocal Microscopy: A Useful Tool to Select the Location of a Punch Biopsy in a Large, Clinically Indistinctive Lesion. Case Rep Dermatol. 2013 Apr 25;5(1):129-32. doi: 10.1159/000351258. Print 2013 Jan.
PubMed 23687492Peppelman M, Nguyen KP, Hoogedoorn L, van Erp PE, Gerritsen MJ. Reflectance confocal microscopy: non-invasive distinction between actinic keratosis and squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1302-9. doi: 10.1111/jdv.12806. Epub 2014 Oct 30.
PubMed 25357235Hoogedoorn L, Peppelman M, Blokx WAM, van Erp PEJ, Gerritsen MP. Prospective differentiation of clinically difficult to distinguish nodular basal cell carcinomas and intradermal nevi by non-invasive Reflectance Confocal Microscopy: a case series study. J Eur Acad Dermatol Venereol. 2015 Feb;29(2):330-336. doi: 10.1111/jdv.12548. Epub 2014 May 20.
PubMed 24841762Longo C, Lallas A, Kyrgidis A, Rabinovitz H, Moscarella E, Ciardo S, Zalaudek I, Oliviero M, Losi A, Gonzalez S, Guitera P, Piana S, Argenziano G, Pellacani G. Classifying distinct basal cell carcinoma subtype by means of dermatoscopy and reflectance confocal microscopy. J Am Acad Dermatol. 2014 Oct;71(4):716-724.e1. doi: 10.1016/j.jaad.2014.04.067. Epub 2014 Jun 11.
PubMed 24928707Peppelman M, Nguyen KP, Alkemade HA, Maessen-Visch B, Hendriks JC, van Erp PE, Adang EM, Gerritsen MJ. Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2016 Jun 30;5(2):e114. doi: 10.2196/resprot.5757.
PubMed 27363577
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02623101
- Acronym / sponsor ID
- RCM-onco ZonMw-1
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Reflectance confocal microscopy, Basal cell carcinoma, Biopsy, Diagnostics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Mavig GmbH
- Study start
- 1 Dec 2015
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Dec 2015 (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.
Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.
Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.
Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.
Detailed description
INTRODUCTION AND RATIONALE:
Skin cancer is the most common cancer and its incidence is increasing rapidly in Western countries. In the Netherlands the registry of skin cancer is poor, however based on recent literature and guidelines the investigators estimate the number of new malignant skin tumors and the precursor actinic keratosis (AK) in 2015 at around 235,278, having a major impact on the health care system. Moreover, it is predicted that numbers of skin cancer will rise with 4.5-8% per year, depending on the type of skin cancer. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). In case of suspicion on NMSC, at present, the pathological examination of a biopsy is the gold standard. In case of clinical suspicion on AK, the diagnosis is made à vue, without pathological confirmation. In the United States, already in 2003, skin cancer was found to be among the most costly of all cancers to treat, thus, it is evident that skin cancer places an enormous burden on western healthcare systems with increasing costs. As BCC is the most common skin cancer (about 75% of all skin cancers) with an estimated incidence of 51,000 new tumors in 2015, this study will focus on this skin cancer type.
HEALTH CARE EFFICIENCY PROBLEM:
As described above, the incidences of the various malignant skin tumours are increasing dramatically. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. With the implementation of reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis is assessed at the first consultation and the patient can be treated instantly. A second consultation for explaining the diagnosis is than not necessary, which time can then be used for other new patients. Also, with the conventional diagnostic procedure (pathological investigation of a skin biopsy) the investigators experience in 29% of the cases a sample error, so the BCC subtype is not correctly identified, and as treatment depends on BCC subtype many patients need a subsequent treatment because of treatment failure or recurrence. Also for pathologists, to examine skin tumor after skin tumor is not that efficient and challenging. More pathologists are needed if there will not be other diagnostic techniques in the future. RCM will also, not unimportantly, lower the costs for diagnosing skin cancer.
USUAL CARE:
Currently, in case of suspicion on NMSC, including BCC, an invasive diagnostic biopsy for pathological examination is performed.Treatment choices depend on BCC subtype.
THE INTERVENTION TO BE INVESTIGATED:
RCM is a non-invasive imaging technique. It provides real time images of cell- and tissue structures and dynamics in situ, without the need for ex vivo tissue samples. RCM visualizes human skin up to a depth of around 250 μm. Most, but not all tumors can be visualized. For thicker tumors RCM may help to find the optimal localization to perform a biopsy, as superficial features in these tumors may help to spot these. Moreover, the whole tumor can be imaged by RCM and a diagnosis can be made instantly.
RCM features for skin cancer are reported, which showed a high correlation with conventional pathological features. These features allow to diagnose AK and SCC, and subtypes in BCC (superficial, nodular, micronodular, infiltrative and mixed type BCCs).
RCM in the RELEVANCE FOR PRACTICE
Skin cancer is responsible for 50% of the costs in dermatological patient care, 75-80% of these costs are caused by BCC. These costs will increase even more, as incidence rates will rise further. As described above, the gold standard is pathological investigation of a biopsy or of an excision. However, pathological diagnosis of a biopsy often results in sampling errors, as only a small part of the tumor is investigated resulting in potentially inappropriate chosen therapies. The subtypes of BCC are treated differently. As a sample error may lead to treatment failures or recurrences, other subsequent treatments are needed, increasing costs. In addition, the conventional method is unfriendly for patients, as it is invasive, painful, scarring, and the diagnosis is not instantly available. In order to implement patient friendly RCM in daily BCC care, a large prospective study is needed. The ability of RCM in determining the correct diagnosis and subtyping BCC needs to be investigated as well as preparing protocols for use in patient care. It is believed that this diagnostic imaging technique will be more cost-effective and more patient friendly as compared to the biopsy procedure, the gold standard at present. Therefore, the purpose of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.
Study design: Randomized controlled trail. Comparison with usual care; punch biopsy and excision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care procedure | Active comparator | Procedure: Punch biopsy, Procedure: Surgical excisionClinical suspected basal cell carcinomas, of all subtypes, will be diagnosed by conventional 3mm punch biopsy of the most clinical suspicious part of the lesion. Punch biopsies will be performed under local anesthetics using 1% xylocaine/adrenaline. Hematoxylin/eosin stained sections of the punch biopsies will be evaluated by an experienced pathologist. Subjects will receive surgical excision according to subtype. When there is any doubt by reflectance confocal microscopic diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma. |
| Reflectance confocal microscopy (RCM) | Experimental | Device: Reflectance confocal microscopy, Procedure: Surgical excisionThe Vivascope 1500 and Vivascope 3000 (handheld divice) will be used (CE certified, Lucid Technologies, Henrietta, NY, USA). Reflectance confocal microscopy (RCM) imaging will be performed on clinical suspected basal cell carcinomas, of all subtypes. When there are signs of a basal cell carcinoma imaged by RCM, subjects will receive surgical excision according to subtype. When there is any doubt by RCM diagnosis, a punch biopsy will also be obtained and the lesion will be excized when the biopsy reveals a basal cell carcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to adhere to all requirements of the study
- Patients must be willing to give written informed consent
- Clinically diagnosed/ clinical suspicion of basal cell carcinoma
Key exclusion criteria (4 listed)
- Participating in other investigational research currently or in the previous 28 days before the study
- Patient is having a medical condition which excludes participating the research, according to the investigator
- Incapacitated subjects will not be included
- Lesion(s) on parts of the body which do not allow to adequately image the tumour with RCM.
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, Vivascope 3000Non-invasive imaging of the lesion | Device | Reflectance confocal microscopy (RCM) |
| Punch biopsyAlso: BiopsyObtaining a skin sample of the suspicious lesion under local anesthetics | Procedure or surgery | Standard of care procedure |
| Surgical excisionAlso: Surgical removal, SurgeryExcision of the basal cell carcinoma lesion under local anesthetics | Procedure or surgery | Reflectance confocal microscopy (RCM), Standard of care procedure |
Primary outcome
The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen
Time frame: Through study completion, an average of 3 years
3 secondary outcomes
Quality of life (Qol)
Time frame: Through study completion, an average of 3 years
Cost effectiveness of Reflectance confocal microscopy as diagnostic tool to diagnose basal cell carcinoma
Time frame: Through study completion, an average of 3 years
Quality Adjusted Live Years (QALY's)
Time frame: Through study completion, an average of 3 years
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 20 Sep 2019.
- Background: PubMed 21264452Flohil SC, de Vries E, Neumann HA, Coebergh JW, Nijsten T. Incidence, prevalence and future trends of primary basal cell carcinoma in the Netherlands. Acta Derm Venereol. 2011 Jan;91(1):24-30. doi: 10.2340/00015555-1009.
- Background: PubMed 23510990Flohil SC, van der Leest RJ, Dowlatshahi EA, Hofman A, de Vries E, Nijsten T. Prevalence of actinic keratosis and its risk factors in the general population: the Rotterdam Study. J Invest Dermatol. 2013 Aug;133(8):1971-8. doi: 10.1038/jid.2013.134. Epub 2013 Mar 19.
- Background: PubMed 12637924Housman TS, Feldman SR, Williford PM, Fleischer AB Jr, Goldman ND, Acostamadiedo JM, Chen GJ. Skin cancer is among the most costly of all cancers to treat for the Medicare population. J Am Acad Dermatol. 2003 Mar;48(3):425-9. doi: 10.1067/mjd.2003.186.
- Background: PubMed 22759209Wolberink EA, Pasch MC, Zeiler M, van Erp PE, Gerritsen MJ. High discordance between punch biopsy and excision in establishing basal cell carcinoma subtype: analysis of 500 cases. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):985-9. doi: 10.1111/j.1468-3083.2012.04628.x. Epub 2012 Jul 3.
- Background: PubMed 24158236Peppelman M, Wolberink EA, Blokx WA, van de Kerkhof PC, van Erp PE, Gerritsen MJ. In vivo diagnosis of basal cell carcinoma subtype by reflectance confocal microscopy. Dermatology. 2013;227(3):255-62. doi: 10.1159/000354762. Epub 2013 Oct 18.
- Background: PubMed 23687492Peppelman M, Wolberink EA, Koopman RJ, van Erp PE, Gerritsen MJ. In vivo Reflectance Confocal Microscopy: A Useful Tool to Select the Location of a Punch Biopsy in a Large, Clinically Indistinctive Lesion. Case Rep Dermatol. 2013 Apr 25;5(1):129-32. doi: 10.1159/000351258. Print 2013 Jan.
- Background: PubMed 25357235Peppelman M, Nguyen KP, Hoogedoorn L, van Erp PE, Gerritsen MJ. Reflectance confocal microscopy: non-invasive distinction between actinic keratosis and squamous cell carcinoma. J Eur Acad Dermatol Venereol. 2015 Jul;29(7):1302-9. doi: 10.1111/jdv.12806. Epub 2014 Oct 30.
- Background: PubMed 24841762Hoogedoorn L, Peppelman M, Blokx WAM, van Erp PEJ, Gerritsen MP. Prospective differentiation of clinically difficult to distinguish nodular basal cell carcinomas and intradermal nevi by non-invasive Reflectance Confocal Microscopy: a case series study. J Eur Acad Dermatol Venereol. 2015 Feb;29(2):330-336. doi: 10.1111/jdv.12548. Epub 2014 May 20.
- Background: PubMed 24928707Longo C, Lallas A, Kyrgidis A, Rabinovitz H, Moscarella E, Ciardo S, Zalaudek I, Oliviero M, Losi A, Gonzalez S, Guitera P, Piana S, Argenziano G, Pellacani G. Classifying distinct basal cell carcinoma subtype by means of dermatoscopy and reflectance confocal microscopy. J Am Acad Dermatol. 2014 Oct;71(4):716-724.e1. doi: 10.1016/j.jaad.2014.04.067. Epub 2014 Jun 11.
- Derived from this study: PubMed 27363577Peppelman M, Nguyen KP, Alkemade HA, Maessen-Visch B, Hendriks JC, van Erp PE, Adang EM, Gerritsen MJ. Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial. JMIR Res Protoc. 2016 Jun 30;5(2):e114. doi: 10.2196/resprot.5757.
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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.
M JP Gerritsen, MD, PhD principal investigator
Radboud University Medical Center, Department of Dermatology
3 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 Radboud University Medical Center at 3 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 3 inclusion and 4 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 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen (time frame: Through study completion, an average of 3 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 NCT02623101, which also lists 10 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 20 Sep 2019.