Viewing Study NCT05257551


Ignite Creation Date: 2025-12-24 @ 11:45 PM
Ignite Modification Date: 2026-01-01 @ 12:41 PM
Study NCT ID: NCT05257551
Status: RECRUITING
Last Update Posted: 2025-05-06
First Post: 2022-01-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and tissue samples will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2022-01-20', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To measure biomarkers of SCLC using the TEMPUS xT assay', 'timeFrame': 'Up to 4 years', 'description': 'To measure specific biomarkers of SCLC subtypes and outcomes using the TEMPUS xT assay'}, {'measure': 'To identify biomarkers and mechanisms of progression', 'timeFrame': 'Up to 4 years', 'description': 'To identify biomarkers and mechanisms of progression from EP + PDL1-i therapy'}, {'measure': 'To study progression free survival (PFS) and overall survival (OS)', 'timeFrame': 'Up to 4 years', 'description': 'To study real-world PFS and OS as measured by the treating clinician'}], 'primaryOutcomes': [{'measure': 'To determine if tumor tissue transcriptional subtypes can be detected', 'timeFrame': 'Up to 4 years', 'description': 'To determine prospectively if SCLC tumor tissue transcriptional subtypes can be detected by Tempus\\|xT RNAseq'}, {'measure': 'To characterize relationship between tissue transcriptional subtype and clinical outcomes', 'timeFrame': 'Up to 4 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'To assess the potential for liquid biopsy in SCLC', 'timeFrame': 'Up to 4 years', 'description': 'To use blood based assays to assess the complementarity of circulating biomarkers to tissue based methods'}, {'measure': 'To test which tissue and sample variables confound gene expression subtypes', 'timeFrame': 'Up to 4 years', 'description': 'To measure how variable transcriptional measurements are across tissue characteristics such as site of biopsy and type of biopsy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Oncology', 'Observational', 'Genomic Profiling', 'Precision medicine', 'SCLC', 'Small Cell Lung Cancer', 'NGS', 'Biomarkers', 'ctDNA', 'Transcriptomics'], 'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '4972690', 'type': 'BACKGROUND', 'citation': 'Ghosh S, Bilton JL. 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Epub 2020 Feb 17.'}, {'pmid': '33086069', 'type': 'BACKGROUND', 'citation': 'Tlemsani C, Pongor L, Elloumi F, Girard L, Huffman KE, Roper N, Varma S, Luna A, Rajapakse VN, Sebastian R, Kohn KW, Krushkal J, Aladjem MI, Teicher BA, Meltzer PS, Reinhold WC, Minna JD, Thomas A, Pommier Y. SCLC-CellMiner: A Resource for Small Cell Lung Cancer Cell Line Genomics and Pharmacology Based on Genomic Signatures. Cell Rep. 2020 Oct 20;33(3):108296. doi: 10.1016/j.celrep.2020.108296.'}, {'pmid': '31217577', 'type': 'BACKGROUND', 'citation': 'Zepp JA, Morrisey EE. Cellular crosstalk in the development and regeneration of the respiratory system. Nat Rev Mol Cell Biol. 2019 Sep;20(9):551-566. doi: 10.1038/s41580-019-0141-3. Epub 2019 Jun 19.'}, {'pmid': '29535911', 'type': 'BACKGROUND', 'citation': 'Zhang W, Girard L, Zhang YA, Haruki T, Papari-Zareei M, Stastny V, Ghayee HK, Pacak K, Oliver TG, Minna JD, Gazdar AF. Small cell lung cancer tumors and preclinical models display heterogeneity of neuroendocrine phenotypes. Transl Lung Cancer Res. 2018 Feb;7(1):32-49. doi: 10.21037/tlcr.2018.02.02.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This protocol targets patients with Small Cell Lung Cancer (SCLC)', 'healthyVolunteers': False, 'eligibilityCriteria': 'The following are the inclusion criteria. Participants are eligible to be included in this study only if all the following criteria apply. The participant has/is:\n\n* Histologically confirmed small cell lung cancer diagnosis\n* Diagnosis made with excisional or core needle biopsy specimen (fine needle aspirate may be permitted with approval from the PI)\n* Subjects must submit fresh or archived FFPE tumor sample to the central laboratory\n* ECOG performance status of 0-2 at time of enrollment\n* Planned extensive stage first-line therapy of etoposide plus carboplatin plus PD-L1 inhibitor (atezolizumab or durvalumab)\n* Extensive stage disease at time of diagnosis\n* Willing and able to provide informed consent\n* Radiotherapy is permitted as long as there is measurable disease outside of the radiotherapy port\n\nParticipants will be excluded from the study if any of the following criteria apply. The participant has/is:\n\n* History of prior systemic treatment of SCLC\n* Prior diagnosis of non-small cell lung cancer is excluded if the cancer is diagnosed \\< 3 years prior to study entry. Additionally, the participant must be off all therapy for the NSCLC at the time of study entry.\n* Mixed small cell and non-small cell histology\n* Suspected metastatic cancer from other sites (i.e., those without a known or suspected lung primary diagnosis)\n* Not willing to have additional blood samples collected'}, 'identificationModule': {'nctId': 'NCT05257551', 'briefTitle': 'Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tempus AI'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TP-CA-003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Small Cell Lung Cancer (SCLC)', 'description': '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.', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Patients with Small Cell Lung Cancer (SCLC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Cancer and Blood Specialty Clinic', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Evelina Reventaite', 'role': 'CONTACT', 'phone': '303-724-9677'}, {'name': 'Tejas Patil, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashton Todd-Hitchcock', 'role': 'CONTACT', 'phone': '309-243-3000'}, {'name': 'Mohammad (Fahad) Asad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Illinois Cancer Care', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jenna Los', 'role': 'CONTACT', 'phone': '410-955-5288'}, {'name': 'Lonny Yarmus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Englewood Health Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley Delgado', 'role': 'CONTACT', 'email': 'ashley_delgado@med.unc.edu', 'phone': '984-520-7329'}, {'name': 'Jason Akulian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Wayne Thompson', 'role': 'CONTACT', 'phone': '513-865-5020'}, {'name': 'James Maher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TriHealth Cancer Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Moon', 'role': 'CONTACT', 'email': 'jennifer.moon@osumc.edu', 'phone': '614-293-7581'}, {'name': 'Asrar Alahmadi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'OhioHealth Research Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Oklahoma Cancer Specialists and Research Institutes', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Stough', 'role': 'CONTACT'}, {'role': 'CONTACT', 'phone': '717-741-9229'}, {'name': 'Chanh Huynh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Care Association of York', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}], 'centralContacts': [{'name': 'Sculptor Study', 'role': 'CONTACT', 'email': 'sculptor-study@tempus.com', 'phone': '833-514-4187'}], 'overallOfficials': [{'name': 'Virginia Rhodes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tempus AI, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tempus AI', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}