Clinical performance of the Nevisense system in cutaneous melanoma detection: An international, multicentre, prospective and blinded clinical trial on efficacy and safety

British Journal of Dermatology

Volumn 171, Issue 5, 2014, Pages 1099-1107

  Malvehy, J ^a   Hauschild, A ^b   Curiel Lewandrowski, C ^c   Mohr, P ^d   Hofmann Wellenhof, R ^e   Motley, R ^f   Berking, C ^g   Grossman, D ^h   Paoli, J ⁱ   Loquai, C ^j   Olah, J ^k   Reinhold, U ^l   Wenger, H ^m   Dirschka, T ⁿ   Davis, S ^o   Henderson, C ^p   Rabinovitz, H ^q   Welzel, J ^r   Schadendorf, D ^s   Birgersson, U ^t,u  

^a UNIVERSITY OF BARCELONA   (Spain)

^b UNIVERSITY OF KIEL   (Germany)

^c UNIVERSITY OF ARIZONA   (United States)

^d Elbe Klinikum Buxtehude   (Germany)

^e UNIVERSITY OF GRAZ   (Austria)

^f UNIVERSITY HOSPITAL OF WALES   (United Kingdom)

^g LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^h UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

ⁱ SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^j JOHANNES GUTENBERG UNIVERSITY   (Germany)

^k UNIVERSITY OF SZEGED   (Hungary)

^l UNIVERSITY OF BONN   (Germany)

^m RYHOV COUNTY HOSPITAL   (Sweden)

ⁿ Dermatologische Praxis   (Germany)

^o Dermatology Clinical Research Center   (United States)

^p UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^q SKIN AND CANCER ASSOCIATES   (United States)

^r General Hospital Augsburg   (Germany)

^s UNIVERSITY OF DUISBURG ESSEN   (Germany)

^t Intervention and Technology   (Sweden)

^u SciBase AB   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; BASAL CELL CARCINOMA; CANCER DIAGNOSIS; CUTANEOUS MELANOMA; DIAGNOSIS; ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY; EPILUMINESCENCE MICROSCOPY; FEMALE; FOLLOW UP; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MALE; MELANOMA; MULTICENTER STUDY; NEVISENSE SYSTEM; PATIENT SAFETY; PHOTOGRAPHY; PREDICTIVE VALUE; PROSPECTIVE STUDY; SINGLE BLIND PROCEDURE; SKIN CANCER; SKIN DEFECT; SQUAMOUS CELL CARCINOMA; YOUNG ADULT; ADOLESCENT; AGED; CLINICAL TRIAL; EARLY DIAGNOSIS; EVALUATION STUDY; IMPEDANCE; MIDDLE AGED; PATHOLOGY; PROCEDURES; SENSITIVITY AND SPECIFICITY; SKIN TUMOR; STANDARDS; VERY ELDERLY;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CARCINOMA, BASAL CELL; CARCINOMA, SQUAMOUS CELL; DERMOSCOPY; DIELECTRIC SPECTROSCOPY; EARLY DETECTION OF CANCER; ELECTRIC IMPEDANCE; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; PATIENT SAFETY; PHOTOGRAPHY; PROSPECTIVE STUDIES; SENSITIVITY AND SPECIFICITY; SKIN NEOPLASMS; YOUNG ADULT;

EID: 84911448090     PISSN: 00070963     EISSN: 13652133     Source Type: Journal    
DOI: 10.1111/bjd.13121     Document Type: Article

References (58)

1. Tsao H, Atkins M, Sober A, et al,. Management of cutaneous melanoma. N Engl J Med 2004; 351: 998-1012.
2. Balch C, Gershenwald J, Soong S-J, et al,. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009; 36: 6199-206.
3. Soyer HP, Smolle J, Leitinger G, et al,. Diagnostic reliability of dermoscopic criteria for detecting malignant melanoma. Dermatology 1995; 190: 25-30.
4. Binder M, Kittler H, Seeber A, et al,. Epiluminescence microscopybased classification of pigmented skin lesions using computerized image analysis and an artificial neural network. Melanoma Res 1998; 8: 261-6.
5. Lorentzen H, Weismann K, Petersen CS, et al,. Clinical and dermatoscopic diagnosis of malignant melanoma: assessed by expert and non-expert groups. Acta Derm Venereol 1999; 79: 301-4.
6. Collas H, Delbarre M, De Preville PA, et al,. Dermatologists of the Postgraduate Association of Haute-Normandie. Evaluation of the diagnosis of pigmented tumors of the skin and factors leading to a decision to excise. Ann Dermatol Venereol 1999; 126: 494-500.
7. Seidenari S, Pellicani G, Gianetti A,. Digital videomicroscopy and image analysis with automatic classification for detection of thin melanomas. Melanoma Res 1999; 9: 163-71.
8. Andreassi L, Perotti R, Rubegni P, et al,. Digital dermoscopy analysis for the differentiation of atypical nevi and early melanoma. Arch Dermatol 1999; 135: 1459-65.
9. Bataille V, Sasieni P, Curley RK, et al,. Melanoma yield, number of biopsies and missed melanomas in a British teaching hospital pigmented lesion clinic: a 9-year retrospective study. Br J Dermatol 1999; 140: 243-8.
10. Benelli C, Roscetti E, Dal Pozzo V,. Reproducibility of a dermoscopic method (7FFM) for the diagnosis of malignant melanoma. Eur J Dermatol 2000; 10: 110-14.
11. Stanganelli I, Serafini M, Bucchi LA,. A cancer-registry-assisted evaluation of the accuracy of digital epiluminescence microscopy associated with clinical examination of pigmented skin lesions. Dermatology 2000; 200: 11-16.
12. Ganster H, Pinz A, Röhrer R, et al,. Automated melanoma recognition. IEEE Trans Med Imaging 2001; 3: 233-9.
13. Bafounta ML, Beauchet A, Aegerter P,. Is dermoscopy (epiluminescence microscopy) useful for diagnosis of melanoma? Arch Dermatol 2001; 137: 1343-50.
14. Megahed M, Schön M, Selimovic D, et al,. Reliability of diagnosis of melanoma in situ. Lancet 2002; 359: 1921-2.
15. Offidani A, Simonetti O, Bernardini O, et al,. General practitioners' accuracy in diagnosing skin cancers. Dermatology 2002; 205: 127-30.
16. Kittler H, Pehamberger H, Wolff K, et al,. Diagnostic accuracy of dermoscopy. Lancet Oncol 2002; 3: 159-65.
17. English D, Burton R, del Mar C, et al,. Evaluation of aid to diagnosis of pigmented skin lesions in general practice: controlled trial randomised by practice. BMJ 2003; 327: 1-6.
18. Argenziano G, Soyer HP, Chimenti S, et al,. Dermoscopy of pigmented skin lesions: results of a consensus meeting via the Internet. J Am Acad Dermatol 2003; 48: 679-93.
19. Carli P, Nardini P, Crocetti E, et al,. Frequency and characteristics of melanomas missed at a pigmented lesion clinic: a registry-based study. Melanoma Res 2004; 14: 403-7.
20. Youl P, Baade P, Janda M, et al,. Diagnosing skin cancer in primary care: how do mainstream general practitioners compare with primary care skin cancer clinic doctors? Med J Aust 2007; 187: 215-20.
21. Carli P, De Giorgi V, Crocetti E, et al,. Improvement of malignant/benign ratio in excised melanocytic lesions in the 'dermoscopy era': a retrospective study 1997-2001. Br J Dermatol 2004; 150: 687-92.
22. English DR, Del Mar C, Burton RC,. Factors influencing the number needed to excise: excision rates of pigmented lesions by general practitioners. Med J Aust 2004; 180: 16-19.
23. Robinson JK, Nickoloff BJ,. Digital epiluminescence microscopy monitoring of high-risk patients. Arch Dermatol 2004; 140: 49-56.
24. Banky JP, Kelly JW, English DR, et al,. Incidence of new and changed nevi and melanomas detected using baseline images and dermoscopy in patients at high risk for melanoma. Arch Dermatol 2005; 141: 998-1006.
25. Soares T, Laman S, Yiannias J, et al,. Factors leading to the biopsy of 1547 pigmented lesions at Mayo Clinic, Scottsdale, Arizona, in 2005. Int J Dermatol 2009; 48: 1053-6.
26. Chen SC, Pennie ML, Kolm P, et al,. Diagnosing and managing cutaneous pigmented lesions: primary care physicians versus dermatologists. J Gen Intern Med 2006; 21: 678-82.
27. Byrnes P, Ackermann E, Williams I, et al,. Management of skin cancer in Australia. A comparison of general practice and skin cancer clinics. Aust Fam Physician 2007; 36: 1073-5.
28. Nathansohn N, Orenstein A, Trau H, et al,. Pigmented lesions clinic for early detection of melanoma: preliminary results. Isr Med Assoc J 2007; 9: 708-12.
29. Fuller SR, Bowen GM, Tanner B, et al,. Digital dermoscopic monitoring of atypical nevi in patients at risk for melanoma. Dermatol Surg 2007; 33: 1198-206.
30. Vestergaard ME, Macaskill P, Holt PE, et al,. Dermoscopy compared with naked eye examination for the diagnosis of primary melanoma: a meta-analysis of studies performed in a clinical setting. Br J Dermatol 2008; 159: 669-76.
31. Heal CF, Raasch BA, Buettner PG, et al,. Accuracy of clinical diagnosis of skin lesions. Br J Dermatol 2008; 159: 661-8.
32. Menzies S, Emery J, Staples M, et al,. Impact of dermoscopy and short-term sequential digital dermoscopy imaging for the management of pigmented lesions in primary care: a sequential intervention trial. Br J Dermatol 2009; 161: 1270-7.
33. Warshaw EM, Lederle FA, Grill JP, et al,. Accuracy of teledermatology for pigmented neoplasms. J Am Acad Dermatol 2009; 61: 753-65.
34. Rosendahl C, Tschandl P, Cameron A, et al,. Diagnostic accuracy of dermatoscopy for melanocytic and nonmelanocytic pigmented lesions. J Am Acad Dermatol 2011; 64: 1068-73.
35. Salerni G, Carrera C, Lovatto L, et al,. Characterization of 1152 lesions excised over 10 years using total-body photography and digital dermatoscopy in the surveillance of patients at high risk for melanoma. J Am Acad Dermatol 2012; 67: 836-45.
36. Salerni G, Terán T, Puig S, et al,. Meta-analysis of digital dermoscopy follow-up of melanocytic skin lesions: a study on behalf of the International Dermoscopy Society. J Eur Acad Dermatol Venereol 2013; 27: 805-14.
37. Guitera P, Menzies S,. State of the art of diagnostic technology for early-stage melanoma. Expert Rev Anticancer Ther 2011; 11: 715-23.
38. Terushkin V, Oliviera S, Marghoob A, et al,. Use of and beliefs about total body photography and dermatoscopy among US dermatology training programs: an update. J Am Acad Dermatol 2010; 62: 794-803.
39. Salerni G, Carrera C, Lovatto L, et al,. Benefits of total body photography and digital dermatoscopy ("two-step method of digital follow-up") in the early diagnosis of melanoma in patients at high risk for melanoma. J Am Acad Dermatol 2012; 67: 17-27.
40. Curiel-Lewandrowski C, Williams CM, Swindells KJ, et al,. Use of in vivo confocal microscopy in malignant melanoma: an aid in diagnosis, and assessment of surgical and non-surgical therapeutic approaches. Arch Dermatol 2004; 140: 1127-32.
41. Guitera P, Menzies SW, Longo C, et al,. In vivo confocal microscopy for diagnosis of melanoma and basal cell carcinoma using a two-step method: analysis of 710 consecutive clinically equivocal cases. J Invest Dermatol 2012; 132: 2386-94.
42. Lui H, Zhao J, McLean D, et al,. Real-time Raman spectroscopy for in vivo skin cancer diagnosis. Cancer Res 2012; 72: 2491-500.
43. Boden I, Nyström J, Lundskog B, et al,. Non-invasive identification of melanoma with near-infrared and skin impedance spectroscopy. Skin Res Technol 2013; 19: 473-8.
44. Moheit G, Cognetta A, Ferris L, et al,. The performance of MelaFind. Arch Dermatol 2011; 147: 188-94.
45. Menzies SW, Bischof L, Talbot H, et al,. The performance of SolarScan: an automated dermoscopy image analysis instrument for the diagnosis of primary melanoma. Arch Dermatol 2005; 141: 1388-96.
46. Wachsman W, Morhenn V, Palmer T, et al,. Noninvasive genomic detection of melanoma. Br J Dermatol 2011; 164: 797-806.
47. Åberg P, Birgersson U, Elsner P, et al,. Electrical impedance spectroscopy and the diagnostic accuracy for malignant melanoma. Exp Dermatol 2011; 20: 648-52.
48. Mohr P, Birgersson U, Berking C, et al,. Electrical impedance spectroscopy as a potential adjunct diagnostic tool for cutaneous melanoma. Skin Research Technol 2013; 19: 75-83.
49. Friedman RJ, Rigel DS, Kopf AW,. Early detection of malignant melanoma: the role of physician examination and self-examination of the skin. CA Cancer J Clin 1985; 35: 130-51.
50. Abbasi N, Shaw H, Rigel D, et al,. Early diagnosis of cutaneous melanoma revisiting the ABCD criteria. JAMA 2004; 292: 2771-6.
51. Nachbar F, Stolz W, Merkle T, et al,. The ABCD rule of dermatoscopy: high prospective value in the diagnosis of doubtful melanocytic skin lesions. J Am Acad Dermatol 1994; 30: 551-9.
52. Argenziano G, Fabbrocini G, Carli P, et al,. Epiluminescence microscopy for the diagnosis of doubtful melanocytic skin lesions: comparison of the ABCD rule of dermatoscopy and a new 7-point checklist based on pattern analysis. Arch Dermatol 1998; 134: 1563-70.
53. Bataille V,. Risk factors for melanoma development. Expert Rev Dermatol 2009; 4: 533-9.
54. Grob JJ, Bonerandi JJ,. The 'ugly duckling' sign: identification of the common characteristics of nevi in an individual as a basis for melanoma screening. Arch Dermatol 1998; 134: 103-4.
55. Gachon J, Beaulieu P, Sei JF, et al,. First prospective study of the recognition process of melanoma in dermatological practice. Arch Dermatol 2005; 141: 434-8.
56. Hofmann-Wellenhof R, Blum A, Wolf IH, et al,. Dermoscopic classification of atypical melanocytic nevi (Clark nevi). Arch Dermatol 2001; 137: 1575-80.
57. Aldridge R, Naysmith L, Ooi E, et al,. The importance of a full clinical examination: assessment of index lesions referred to a skin cancer clinic without a total body skin examination would miss one in three melanoma. Acta Derm Venereol 2013; 93: 689-92.
58. Balch C, Buzaid A, Soong SJ, et al,. Final version of the American Joint Committee on Cancer staging system for cutaneous melanoma. J Clin Oncol 2002; 19: 3635-48.