Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273709
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Brief Title:
Remote Assessment of OCT Scans for BCC Detection
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
The Value of Visual Inspection When Remotely Diagnosing Basal Cell Carcinoma on Optical Coherence Tomography Scans a Diagnostic Case-control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
None
Brief Summary:
Basal cell carcinoma BCC is the most common form of cancer and entails approximately 80 of all cutaneous malignancies This locally destructive neoplasm is commonly diagnosed by punch biopsy which is considered painful causes procedural scarring and carries a small risk of infection and re-bleeding associated with invasive procedures Moreover awaiting the results of the subsequent histopathological examination causes treatment delay and can be stressful for the patient The drawbacks of biopsy could be overcome by optical coherence tomography OCT a non-invasive diagnostic modality that may replace biopsy in up to 66 of patients However OCT assessors are scarce which hinders the implementation of OCT This problem may be addressed by teledermatology in which remote OCT assessment by an assessor facilitates simultaneous assessment for multiple clinics Remote OCT assessment withholds the OCT assessor from visually inspecting the lesion But the effect of visual inspection on the diagnostic accuracy remains unknown and the question arises whether visual inspection is necessary for accurate OCT assessment In this diagnostic case-control study we will determine whether distant OCT assessment without visual information on the lesion is non-inferior to distant OCT assessment with clinical and dermoscopic photographs CDP-OCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None