We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05257551
Recruitment Status : Recruiting
First Posted : February 25, 2022
Last Update Posted : December 21, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Tempus Labs

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Small Cell Lung Cancer Other: Observation

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : July 13, 2022
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 Other: Observation
No intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To determine if tumor tissue transcriptional subtypes can be detected [ Time Frame: Up to 4 years ]
    To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by Tempus|xT RNAseq

  2. To characterize relationship between tissue transcriptional subtype and clinical outcomes [ Time Frame: 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


Secondary Outcome Measures :
  1. To assess the potential for liquid biopsy in SCLC [ Time Frame: Up to 4 years ]
    To use blood based assays to assess the complementarity of circulating biomarkers to tissue based methods

  2. To test which tissue and sample variables confound gene expression subtypes [ Time Frame: Up to 4 years ]
    To measure how variable transcriptional measurements are across tissue characteristics such as site of biopsy and type of biopsy


Other Outcome Measures:
  1. To measure biomarkers of SCLC using the TEMPUS xT assay [ Time Frame: Up to 4 years ]
    To measure specific biomarkers of SCLC subtypes and outcomes using the TEMPUS xT assay

  2. To identify biomarkers and mechanisms of progression [ Time Frame: Up to 4 years ]
    To identify biomarkers and mechanisms of progression from EP + PDL1-i therapy

  3. To study progression free survival (PFS) and overall survival (OS) [ Time Frame: Up to 4 years ]
    To study real-world PFS and OS as measured by the treating clinician


Biospecimen Retention:   Samples With DNA
Blood and tissue samples will be collected

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This protocol targets patients with Small Cell Lung Cancer (SCLC)
Criteria

Inclusion Criteria:

  • 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 or 1 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

Exclusion Criteria:

  • History of prior systemic treatment of SCLC
  • History of radiotherapy or planned radiotherapy to all measurable disease foci
  • Prior diagnosis of non-small cell lung cancer
  • Mixed small cell and non-small cell histology
  • Suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)
  • Not willing to have additional blood samples collected
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05257551


Contacts
Layout table for location contacts
Contact: Sculptor Study 833-514-4187 sculptor-study@tempus.com

Locations
Layout table for location information
United States, Illinois
Illinois Cancer Care Recruiting
Peoria, Illinois, United States, 61615
Contact: Trupti Hattiangadi    309-243-3000      
Principal Investigator: Mohammad (Fahad) Asad, MD         
United States, New Jersey
Englewood Health Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Hauwa Adeniji    201-608-2846      
Principal Investigator: Meghan Kaumaya, MD         
United States, Ohio
TriHealth Cancer Institute Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Nicholas Morgan    513-479-3402      
Principal Investigator: James Maher, MD         
OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Hazel Antao    614-788-3880      
Principal Investigator: Arvinder Bhinder, MD         
United States, Oklahoma
Oklahoma Cancer Specialists and Research Institutes Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Stephanie Sandoval    918-505-3201 ext 3339      
Principal Investigator: Paul Zito, MD         
United States, Pennsylvania
Cancer Care Association of York Recruiting
York, Pennsylvania, United States, 17403
Contact: Jennifer Stough         
Contact    717-741-9229      
Principal Investigator: Chanh Huynh, MD         
Sponsors and Collaborators
Tempus Labs
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Anjali Avadhani, MD Tempus Labs, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Howlader, Nnam, A. M. Noone, Me Krapcho, D. Miller, A. Brest, M. Yu, J. Ruhl, et al. 2020."SEER Cancer Statistics Review, 1975--2017." National Cancer Institute.

Layout table for additonal information
Responsible Party: Tempus Labs
ClinicalTrials.gov Identifier: NCT05257551    
Other Study ID Numbers: TP-CA-003
First Posted: February 25, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tempus Labs:
Genomic Profiling
Cancer
Oncology
Observational
Precision medicine
SCLC
 Small Cell Lung Cancer
NGS
Biomarkers
ctDNA
Transcriptomics
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms