Melanoma Clinical Trial
— NNCDOfficial title:
Dermoscopy Evaluation of Pigmented Skin Lesions by a Neuronal Network Clinical Decision Support: an Open Prospective Non Interventional Study
NCT number | NCT03362138 |
Other study ID # | AQ16842 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 6, 2017 |
Est. completion date | March 31, 2019 |
Malignant melanoma (MM) is a deadly cancer, claiming globally about 160000 new cases per year
and 48000 deaths at a 1:28 lifetime incidence (2016).
The golden standard, dermoscopy, enables Dermatologists to diagnose with a sensitivity of
40%, and a 8-12% specificity, approximately. Additional diagnostic abilities are restricted
to devices which are either unproved or experimental.
A new technology of Neuronal Network Clinical Decision Support (NNCD) was developed. It uses
a dermoscopic imaging device and a camera able to capture an image. The photo is transferred
to a Cloud Server and further analyzed by a trained classifier. Classifier training is aimed
at a high accuracy diagnosis of Dysplastic Nevi (DN), Spitz Nevi and Malignant Melanoma
detection with assistance from a Deep Neuronal Learning network (DLN). Diagnosis output is an
excise or do not excise recommendation for pigmented skin lesions.
A total of 80 subjects already referred to biopsy pigmented skin lesions will be examined by
dermoscopy imaging in a non interventional study. Artificial Intelligence output results, as
measured by 2 different dermoscopes, to be compared to ground truth biopsies, by either
classifier decisions or a novel Modified Classifier Technology output decisions.
Primary endpoints are sensitivity and specificity detection of the NNCD techniques. Secondary
endpoints are the positive and negative prediction ratios of NNCD techniques.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 31, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patient aged 18-90 years - A pigmented lesion by dermoscopy. - Clinical management by the examining dermatologist results in biopsy - The diameter of the pigmented area is between 1 and 40 millimeters - The patient has consented to participate in the study and has signed the Informed Consent Form Exclusion Criteria: - Non intact skin (ulcers, bleeding) - The lesion is located within 1 cm of the eye - The lesion is located on mucosal surfaces - The lesion is on or under nails |
Country | Name | City | State |
---|---|---|---|
Israel | Maccabi Healthcare Clinic | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Assuta Hospital Systems |
Israel,
American Academy of Dermatology Ad Hoc Task Force for the ABCDEs of Melanoma, Tsao H, Olazagasti JM, Cordoro KM, Brewer JD, Taylor SC, Bordeaux JS, Chren MM, Sober AJ, Tegeler C, Bhushan R, Begolka WS. Early detection of melanoma: reviewing the ABCDEs. J Am Acad Dermatol. 2015 Apr;72(4):717-23. doi: 10.1016/j.jaad.2015.01.025. Epub 2015 Feb 16. Review. — View Citation
Campos-do-Carmo G, Ramos-e-Silva M. Dermoscopy: basic concepts. Int J Dermatol. 2008 Jul;47(7):712-9. doi: 10.1111/j.1365-4632.2008.03556.x. Review. — View Citation
Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19. Review. — View Citation
Mayer JE, Swetter SM, Fu T, Geller AC. Screening, early detection, education, and trends for melanoma: current status (2007-2013) and future directions: Part I. Epidemiology, high-risk groups, clinical strategies, and diagnostic technology. J Am Acad Dermatol. 2014 Oct;71(4):599.e1-599.e12; quiz 610, 599.e12. doi: 10.1016/j.jaad.2014.05.046. Review. — View Citation
Noor O 2nd, Nanda A, Rao BK. A dermoscopy survey to assess who is using it and why it is or is not being used. Int J Dermatol. 2009 Sep;48(9):951-2. doi: 10.1111/j.1365-4632.2009.04095.x. — View Citation
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity for Classifier results as compared to biopsy | A Sensitivity of at least 75% for Classifier results as compared to biopsy | 15 months | |
Primary | Sensitivity for MCT results as compared to biopsy | A Sensitivity of at least 85% for Classifier results as compared to biopsy | 15 months | |
Secondary | The positive predictive value of MCT | The positive predictive value of MCT, compared to the biopsy result | 15 months | |
Secondary | The negative predictive value of MCT | The negative predictive value of MCT, compared to the biopsy result | 15 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT03979872 -
Risk Information and Skin-cancer Education for Undergraduate Prevention
|
N/A | |
Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
Recruiting |
NCT05077137 -
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
|
Phase 1 | |
Active, not recruiting |
NCT02721459 -
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma
|
Phase 1 | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Recruiting |
NCT05839912 -
Excision of Lymph Node Trial (EXCILYNT) (Mel69)
|
N/A | |
Recruiting |
NCT04971499 -
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT05263453 -
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
|
Phase 2 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
Completed |
NCT03348891 -
TNF in Melanoma Patients Treated With Immunotherapy
|
N/A | |
Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
Completed |
NCT03171064 -
Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
|
Phase 2 | |
Not yet recruiting |
NCT05539118 -
Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT05171374 -
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
|
||
Withdrawn |
NCT02854488 -
Yervoy Pregnancy Surveillance Study
|