SPARC - Screening for Lung Cancer With Platelets Via an AI-enabled RNA-based Classifier
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Sensitivity
研究概览
简要总结
The purpose of this study is to test whether combining a unique analytical approach with changes in platelet RNA expression accurately diagnoses lung cancer. Using retrospective platelet transcriptomic data from 522 patients with non-small cell lung cancer (NSCLC, the most common type of lung cancer), an approach that appears to accurately classify lung cancer has been developed.
The study will build upon these retrospective analyses to prospectively recruit patients with newly diagnosed lung cancer, obtain platelet RNA samples from whole blood, and perform validation analyses. This research will also test whether this approach accurately distinguishes benign from malignant lung nodules.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Population 1: Treatment-Naïve Patients with a Lung Nodule or Lung Cancer
- •Inclusion Criteria:
- •Aged 21 years or older
- •Meeting at least one of the following two criteria:
- •Diagnosed with any stage or type of lung cancer
- •Having at least one lung nodule identified on imaging (e.g., low dose computed tomography [LDCT] or other diagnostic chest imaging) that was completed within 180 days prior to enrollment, and where there is planned or recommended biopsy, surgical resection, radiation therapy, systemic therapy, or other invasive diagnostic or therapeutic procedure to further evaluate the nodule(s) in the next six months based on the clinical judgment of the patient's provider(s)
排除标准
- •Other diagnosis of, or treatment for, any cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally
- •A history of lung cancer or metastatic cancer to the lungs from an extrathoracic primary site with definitive treatment (surgical, medical, or radiotherapy) within the past 2 years
- •Currently receiving any systemic therapy (chemotherapy, immunotherapy, and/or targeted therapy) or radiation therapy for lung cancer
- •Already undergone surgical resection of the lung cancer in part or in whole
- •Have undergone invasive diagnostic or therapeutic procedures (e.g., biopsy, surgery) related to the lung nodule within the past 3 months
- •Unable to provide blood sample
- •Study Population 2: Control Subjects
- •Inclusion Criteria:
- •Aged 21 years or older
- •Exclusion Criteria:
- •Any active malignancy or diagnosis of cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally
- •Treatment for any cancer within the last 6 months except for non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade prostate cancer (defined as Gleason score ≤ 6) treated locally
- •Hospitalization or surgery (other than minor surgery such as mole removal) within the last 8 weeks
- •Renal failure (defined as eGFR < 60 mL/min/1.73m² or on dialysis)
- •Liver failure (defined as having hepatic encephalopathy of any degree, OR moderately severe coagulopathy defined as INR ≥ 1.5, OR known cirrhosis, OR ALT of ≥ 10X ULN, OR total bilirubin of ≥ 3.0 mg/dL, OR diagnosis of liver failure)
- •Decompensated or end-stage heart failure (defined as ACC/AHA Stage C or Stage D heart failure)
- •Venous thrombosis, myocardial infarction, or stroke within the last 8 weeks
- •Currently pregnant or have been pregnant within the last 12 weeks
- •Any blood product transfusion within the last 8 weeks
- •Personal history of lung cancer at any time
- •Unable to provide blood sample
研究组 & 干预措施
Cohort 2: Lung Nodule
Cohort 1 will enroll 120 participants with Lung Nodules (72 patients with Benign Nodules and 48 participants with Malignant Nodules).
Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
干预措施: Platelet RNA-based assay (Diagnostic Test)
Cohort 3: Control Participants without Cancer or Nodule
Cohort 3 will enroll 30 participants without Lunch Cancer or lunch Nodules.
Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
干预措施: Platelet RNA-based assay (Diagnostic Test)
Cohort 1: Lung Cancer
Cohort 1 will enroll 90 participants with Lung Cancer (30 patients with Stage I/II and 60 participants with Stage III/IV).
Following informed consent and during the same visit (study visit 1), up to 20mL (the maximum blood volume collected) of whole blood will be collected by peripheral venipuncture by a site phlebotomist into sterile, 4mL EDTA-containing venipuncture tubes.
干预措施: Platelet RNA-based assay (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: up to one day after study enrollment
Sensitivity of the assay in detecting lung cancer
Specificity
时间窗: up to one day after study enrollment
Specificity of the assay in detecting lung cancer.
Positive predictive value (PPV)
时间窗: up to one day after study enrollment
Positive predictive value (PPV) in distinguishing benign vs. malignant lung nodules.
Negative Predictive Value (NPV)
时间窗: up to one day after study enrollment
Negative predictive value (NPV) in distinguishing benign vs. malignant lung nodules.
次要结局
- Performance Across Lung Cancer Stage(up to one day after study enrollment)
- Performance Across Lung Cancer Histologic Subtypes(up to one day after study enrollment)
- Validation Completion(up to one day after study enrollment)