Tempus Small Cell Lung Cancer Observational Study (Sculptor): A Tissue and Longitudinal Circulating Tumor DNA (ctDNA) Biomarker Profiling Study of Patients With Small Cell Lung Cancer (SCLC) Using Comprehensive Next-Generation Sequencing (NGS) Assays
概览
- 阶段
- 不适用
- 干预措施
- Observation
- 疾病 / 适应症
- Small Cell Lung Cancer
- 发起方
- Tempus AI
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- To characterize relationship between tissue transcriptional subtype and clinical outcomes
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The study is a non-interventional evaluation of participants with SCLC who will receive diagnostic and (where possible) post-progression tumor tissue profiling, alongside plasma ctDNA biomarker profiling in addition to their standard of care therapy and disease surveillance.
研究者
入排标准
入选标准
- •. Participants are eligible to be included in this study only if all the following criteria apply. The participant has/is:
- •Histologically confirmed small cell lung cancer diagnosis
- •Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the PI)
- •Subjects must submit fresh or archived FFPE tumor sample to the central laboratory
- •ECOG performance status of 0-2 at time of enrollment
- •Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1 inhibitor (atezolizumab or durvalumab)
- •Extensive stage disease at time of diagnosis
- •Willing and able to provide informed consent
- •Radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port
- •Participants will be excluded from the study if any of the following criteria apply. The participant has/is:
排除标准
- 未提供
研究组 & 干预措施
Patients with Small Cell Lung Cancer (SCLC)
This protocol will include participants with newly diagnosed extensive stage (stage IV) small cell lung cancer with tissue collected from the primary lung tumor, or metastatic sites outside of the liver or biliary system.
干预措施: Observation
结局指标
主要结局
To characterize relationship between tissue transcriptional subtype and clinical outcomes
时间窗: Up to 4 years
To characterize the relationship between tissue transcriptional subtype and clinical outcomes for EP+PDL1-i therapy based on collection of longitudinal information from medical records
To determine if tumor tissue transcriptional subtypes can be detected
时间窗: Up to 4 years
To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by Tempus\|xT RNAseq
次要结局
- To test which tissue and sample variables confound gene expression subtypes(Up to 4 years)
- To assess the potential for liquid biopsy in SCLC(Up to 4 years)