Soyer H Peter, Jayasinghe Dilki, Rodriguez-Acevedo Astrid J, Collins Louisa G, Caffery Liam J, Whiteman David C, Betz-Stablein Brigid, Osborne Sonya R, Finnane Anna, Horsham Caitlin, Primiero Clare, Gray Leonard C, Janda Monika
Frazer Institute, The University of Queensland Dermatology Research Centre, Brisbane, Queensland, Australia.
Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia.
JAMA Dermatol. 2025 May 1;161(5):472-481. doi: 10.1001/jamadermatol.2025.0211.
Three-dimensional (3D) total-body photography (TBP) can support clinicians in monitoring and identifying changes to skin lesions in patients at high risk of melanoma.
To assess clinical outcomes between patients at high risk of melanoma receiving usual clinical care compared with those receiving usual care plus 3D TBP and sequential digital dermoscopy imaging (SDDI) every 6 months via teledermatology.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted at a research hospital in Brisbane, Australia, from April 2018 to October 2021, with adult patients (≥18 years) at high risk of developing a primary or subsequent melanoma. Data analysis was conducted from March 2022 to June 2024.
Usual care plus 3D-TBP in person and SDDI via teledermatology at baseline, 6, 12, 18, and 24 months. The control group continued usual care and completed online surveys every 6 months.
Number and rates of excisions and/or biopsies of lesions suggestive of melanoma, and results of histopathologic testing.
The analysis included 314 participants (mean [SD] age, 51.6 [12.8] years; 194 females [62%]) who completed all of the study procedures (158 in the intervention and 156 in the control). In all, 1527 excisions (905 intervention and 622 in the control) were performed among 226 participants (122 intervention and 104 controls), with 67 (4%) histopathologically confirmed as melanoma and 402 (26%) as keratinocyte cancer (KC). The mean (SD) number of lesions of any type excised per person was significantly higher in the intervention (5.73 [6.77]; 95% CI, 4.66-6.79) compared to the control group (3.99 [5.72]; 95% CI, 3.08-4.89; P = .02). Fewer melanomas were detected among the intervention group compared with the control (24 [35%] vs 43 [64%], respectively), and therefore, a lower incidence rate: 2.03 (95% CI, 1.30-3.02) vs 3.62 (95% CI, 2.62-4.88), respectively. After 1 year of follow-up, the intervention had a lower, but not statistically significant, rate of melanoma per person: 0.08 (95% CI, 0.03-0.13) compared with 0.16 (95% CI, 0.08-0.25) in the control; an average of 0.86 (95% CI, 0.55-1.16) vs 0.42 (95% CI, 0.24-0.59) KCs per person; and 2.01 (95% CI, 1.50-2.51) vs 1.39 (95% CI, 0.98-1.82) excisions or biopsies per person, respectively.
The results of this randomized clinical trial indicate that the addition of 3D-TPB and SDDI to usual care in a teledermatology setting without AI (artificial intelligence) increased the number and rate of skin excisions and biopsies performed. Further studies are required to compare teledermatology to usual care rather than adding it, and to study whether the use of AI can improve the teledermatology outcomes. Larger studies in multiple settings with a greater number of teledermatologists are needed. This study shows that conducting clinical trials in this setting is feasible.
anzctr.org.au Identifier: ACTRN12618000267257.
三维（3D）全身摄影（TBP）可为临床医生监测和识别黑色素瘤高危患者的皮肤病变变化提供支持。
评估接受常规临床护理的黑色素瘤高危患者与接受常规护理加每6个月通过远程皮肤病学进行一次3D TBP和序贯数字皮肤镜成像（SDDI）的患者之间的临床结局。
设计、地点和参与者：这项随机临床试验于2018年4月至2021年10月在澳大利亚布里斯班的一家研究医院进行，纳入有发生原发性或继发性黑色素瘤高危风险的成年患者（≥18岁）。数据分析于2022年3月至2024年6月进行。
在基线、6、12、18和24个月时，给予常规护理加亲自进行3D-TBP以及通过远程皮肤病学进行SDDI。对照组继续接受常规护理并每6个月完成在线调查。
提示黑色素瘤的病变的切除和/或活检数量及比率，以及组织病理学检测结果。
分析纳入了314名参与者（平均[标准差]年龄为51.6[12.8]岁；194名女性[62%]），他们完成了所有研究程序（干预组158名，对照组156名）。总共在226名参与者（干预组122名，对照组104名）中进行了1527次切除（干预组905次，对照组622次），其中67次（4%）经组织病理学确诊为黑色素瘤，402次（26%）为角质形成细胞癌（KC）。干预组每人切除的任何类型病变的平均（标准差）数量（5.73[6.77]；95%置信区间，4.66 - 6.79）显著高于对照组（3.99[5.72]；95%置信区间，3.08 - 4.89；P = 0.02）。干预组检测到的黑色素瘤比对照组少（分别为24例[35%]对43例[64%]），因此发病率较低：分别为2.03（95%置信区间，1.30 - 3.02）对3.62（95%置信区间，2.62 - 4.88）。随访1年后，干预组每人的黑色素瘤发病率较低，但无统计学意义：0.08（95%置信区间，0.03 - 0.13），而对照组为0.16（95%置信区间，0.08 - 0.25）；每人平均KC为0.86（95%置信区间，0.55 - 1.16）对0.42（95%置信区间，0.24 - 0.59）；每人分别进行2.01（95%置信区间，1.50 - 2.51）次切除或活检对1.39（95%置信区间，0.98 - 1.82）次。
这项随机临床试验的结果表明，在无人工智能（AI）的远程皮肤病学环境中，在常规护理基础上加用3D - TPB和SDDI会增加皮肤切除和活检的数量及比率。需要进一步研究将远程皮肤病学与常规护理进行比较而非相加，并研究使用AI是否能改善远程皮肤病学结局。需要在多个环境中由更多远程皮肤病医生开展更大规模的研究。本研究表明在这种环境下开展临床试验是可行的。
anzctr.org.au标识符：ACTRN12618000267257。
