Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
研究概览
简要总结
AIMS 2 & 3:
In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aim 2 (Patients):
- •Adults age ≥18 years old
- •Histopathology-confirmed Kaposi Sarcoma
- •At least 3 skin lesions
- •Capable of informed consent
- •On treatment for Kaposi Sarcoma
排除标准
- •Aim 2 (Patients):
- •Patients not initiating Kaposi Sarcoma treatment
- •Very ill patients requiring hospitalization
- •Inclusion Criteria - Aim 3 (Patients):
- •Adults age ≥18 years old
- •Histopathology-confirmed Kaposi Sarcoma
- •Capable of informed consent
- •Initiating treatment for Kaposi Sarcoma
- •Exclusion Criteria - Aim 3 (Patients):
- •Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
- •Prior or ongoing Kaposi Sarcoma treatment
研究组 & 干预措施
Aim 3: Patients
Providers will first measure KS lesions using the manual ruler-based method as per usual standard of care for the first three months. After the first three months, providers will switch to using SkinScan3D for KS skin lesion measurement.
干预措施: SkinScan3D (Device)
Aim 2: Patients
Patients will have three discrete skin lesions measured, with lesion area determined by ACTG criteria utilizing the product of longest perpendicular diameters. Patients will also have five 3D snapshots of each of the three target lesions taken, measuring lesion area automatically using SS3D.
干预措施: SkinScan3D (Device)
结局指标
主要结局
Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
时间窗: Approximately 3 months
Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method.
Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only
时间窗: Approximately 3 months
Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1.
Acceptability - Aim 3 Only
时间窗: 6 months
Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention.
Appropriateness - Aim 3 Only
时间窗: 6 months
Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness.
Device usability - Aim 3 Only
时间窗: 6 months
Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score.
Feasibility - Aim 3 Only
时间窗: 6 months
FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context.
次要结局
未报告次要终点