Basal Cell Carcinoma Clinical Trial
— OCT-BCCOfficial title:
Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma
Verified date | May 2021 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Rationale: To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.
Status | Active, not recruiting |
Enrollment | 963 |
Est. completion date | December 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy Exclusion Criteria: - Patients who were incompetent to sign informed consent were excluded |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Centre+ | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Maastricht University |
Netherlands,
Sinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of OCT in diagnosis and subtyping of BCC | The main study parameter is the diagnostic value of OCT in diagnosis BCC defined as accuracy, sensitivity, specificity and negative- and positive diagnostic values. An increase of at least 10 percent in specificity and an equal sensitivity of OCT-based diagnosis is expected, compared with the clinical diagnosis and the golden-standard histopathology. | February 2017-April 2021 | |
Secondary | Developing a deep learning algorithm for automated detection of basal cell carcinoma (BCC) and recognizing three different BCC subtypes in OCT images. | The ability of a deep learning algorithm to classify BCC from other skin lesions within OCT images | June 2020-August 2021 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04552990 -
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT04229277 -
Fast Track Diagnosis of Skin Cancer by Advanced Imaging
|
N/A | |
Completed |
NCT05608902 -
Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
|
||
Completed |
NCT05077033 -
Intratumoral phIL12 GET
|
Phase 1 | |
Active, not recruiting |
NCT04928222 -
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04929535 -
Hydrogen Peroxide Trial to Investigate the Efficacy of 30%H2O2 as a Topical Application Before Definitive Treatment
|
Phase 2 | |
Completed |
NCT02662244 -
Long-pulsed 1064 nm Nd:YAG Laser Treatment of Basal Cell Carcinoma
|
N/A | |
Completed |
NCT00959647 -
A Study of Vismodegib (GDC-0449) in Patients Treated With Vismodegib in a Previous Genentech-sponsored Phase I or II Cancer Study
|
Phase 2 | |
Completed |
NCT00793169 -
Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
|
||
Completed |
NCT00586040 -
Photochemical Tissue Bonding
|
Phase 2 | |
Completed |
NCT00473343 -
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma
|
Phase 3 | |
Active, not recruiting |
NCT06024629 -
cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study
|
||
Not yet recruiting |
NCT05324202 -
New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
|
N/A | |
Withdrawn |
NCT04099446 -
A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
|
||
Completed |
NCT02902822 -
Tele-dermatology of Skin Cancer in a Cohort of Local Health Authority Employees in the Province of Bergamo
|
N/A | |
Completed |
NCT01208831 -
An East Asian Study of LDE225
|
Phase 1 | |
Completed |
NCT01201915 -
A Study Evaluating the Efficacy and Safety of Vismodegib (GDC-0449) in Operable Basal Cell Carcinoma
|
Phase 2 | |
Completed |
NCT01260987 -
Fractional CO2 Laser Assisted Photodynamic Therapy
|
Phase 2/Phase 3 | |
Completed |
NCT01014819 -
A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
|
N/A | |
Completed |
NCT00472043 -
PDT With Metvix 160 mg/g Cream Versus PDT With Placebo Cream in Patients With Primary Nodular Basal Call Carcinoma
|
Phase 3 |