Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02242929
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2014-09-15
Brief Title:
Surgery Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Surgical Excision Versus Combined Treatment With Curettage and Imiquimod for Nodular Basal Cell Carcinoma an Open Non-inferiority Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCIN
Brief Summary:
Basal cell carcinoma BCC is a slow-growing locally invasive malignant epidermal skin tumour It is the most common malignant disease in Caucasians representing approximately 80 of all cases of skin cancer and is therefore an important health problem In the Netherlands incidence rates are 165 for men and 157 for women per 100000 person-years and these rates are rising with 3-10 every year
A simplified histological classification of BCCs includes the following three subtypes nodular superficial and infiltrative variants with the nodular variant being the most frequent type Although a characteristic feature of BCCs is their low risk to metastasize if untreated they may be locally invasive and may induce considerable functional and cosmetic morbidity
The gold standard treatment of all histological BCC subtypes is surgical excision SE but not all patients are eligible for surgery In patients with multiple BCCs and older patients surgery may lead to significant morbidity and in some cases it may result in disfiguring scarring For these reasons and to reduce workload and costs in the healthcare system there is a growing demand for alternative non-invasive treatments An advantage of non-invasive treatment options is that they can be performed by other healthcare professionals such as general practitioners and specialized nurses For treatment of superficial BCCs sBCC non-invasive treatments such as topical imiquimod IMQ 5-fluorouracil 5-FU or photodynamic therapy PDT are already commonly used Our group investigated the efficacy of those three therapies and found that after 3 years BCCs treated with IMQ had a significant lower risk of recurrence compared to the other therapies
A recent study suggests that IMQ besides being an immune-response modifier also directly inhibits sonic hedgehog SHH signalling the most important pathway active in BCCs This targeted effect of IMQ very likely explains the superior therapeutic effect Treatment of nodular BCC nBCC with IMQ has been investigated Without prior curettage high efficacy rates were found although efficacy was still slightly inferior to SE
The investigators hypothesize that the effectiveness of IMQ following prior curettage will not be inferior to SE and that the benefits will be a higher patient satisfaction and lower healthcare costs A recently published discreet choice experiment showed that patients preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment
A simplified histological classification of BCCs includes the following three subtypes nodular superficial and infiltrative variants with the nodular variant being the most frequent type Although a characteristic feature of BCCs is their low risk to metastasize if untreated they may be locally invasive and may induce considerable functional and cosmetic morbidity
The gold standard treatment of all histological BCC subtypes is surgical excision SE but not all patients are eligible for surgery In patients with multiple BCCs and older patients surgery may lead to significant morbidity and in some cases it may result in disfiguring scarring For these reasons and to reduce workload and costs in the healthcare system there is a growing demand for alternative non-invasive treatments An advantage of non-invasive treatment options is that they can be performed by other healthcare professionals such as general practitioners and specialized nurses For treatment of superficial BCCs sBCC non-invasive treatments such as topical imiquimod IMQ 5-fluorouracil 5-FU or photodynamic therapy PDT are already commonly used Our group investigated the efficacy of those three therapies and found that after 3 years BCCs treated with IMQ had a significant lower risk of recurrence compared to the other therapies
A recent study suggests that IMQ besides being an immune-response modifier also directly inhibits sonic hedgehog SHH signalling the most important pathway active in BCCs This targeted effect of IMQ very likely explains the superior therapeutic effect Treatment of nodular BCC nBCC with IMQ has been investigated Without prior curettage high efficacy rates were found although efficacy was still slightly inferior to SE
The investigators hypothesize that the effectiveness of IMQ following prior curettage will not be inferior to SE and that the benefits will be a higher patient satisfaction and lower healthcare costs A recently published discreet choice experiment showed that patients preferred IMQ to surgery regardless of previous experience of BCC symptoms and treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None