Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study

Recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Other: Observation

• Registration Number: NCT05257551
• Lead Sponsor: Tempus AI

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-25
• Study Start: 2022-07-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Small Cell Lung Cancer (SCLC)	Observation	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.

Primary Outcome Measures

Name	Time	Method
To characterize relationship between tissue transcriptional subtype and clinical outcomes	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	Up to 4 years	To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by Tempus\|xT RNAseq

Secondary Outcome Measures

Name	Time	Method
To test which tissue and sample variables confound gene expression subtypes	Up to 4 years	To measure how variable transcriptional measurements are across tissue characteristics such as site of biopsy and type of biopsy
To assess the potential for liquid biopsy in SCLC	Up to 4 years	To use blood based assays to assess the complementarity of circulating biomarkers to tissue based methods

Trial Locations

Locations (11)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Cancer and Blood Specialty Clinic; 🇺🇸 Los Alamitos, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Englewood Health Medical Center; 🇺🇸 Englewood, New Jersey, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

TriHealth Cancer Institute; 🇺🇸 Cincinnati, Ohio, United States

OhioHealth Research Institute; 🇺🇸 Columbus, Ohio, United States

Oklahoma Cancer Specialists and Research Institutes; 🇺🇸 Tulsa, Oklahoma, United States

Cancer Care Association of York; 🇺🇸 York, Pennsylvania, United States