Prospective Multiomic Analysis in Small-Cell Lung Cancer
26. august 2026 opdateret af: Asrar Alahmadi, Ohio State University Comprehensive Cancer Center
Prospective Multiomic Analysis in Small-Cell Lung Cancer to Inform Therapeutic Vulnerabilities and Predict Clinical Outcomes: Deep Phenotyping of Relapsed SCLC Cohort
This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receicing standard of care commercial DLL3 T cell engager.
The goal of the study is to understand the changes in tumor markers over time and examine whether these changes are associated with clinical outcomes.
Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments.
The study does not assign cancer treatment.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The goal of this study is to prospectively and longitudinally collect blood and tumor tissue from patients with relapsed small cell lung cancer (SCLC) receicing standard of care commercial DLL3 T cell engager. We will do a comprehensive multi-omic analysis integrating genomic, transcriptomic, proteomic, and clinical data to investigate mechanisms of resistance, and identify potential therapeutic vulnerabilities.
Primary objective is to assess the feasibility of obtaining paired tumor samples and serial blood collection in relapsed ES-SCLC patients
Secondary objectives are to characterize longitudinal SCLC tumor-associated markers, including DLL3; evaluate concordance between plasma and tissue, ctDNA, protomics and explore associations between molecular findings and clinical outcomes.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
30
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Kontakt:
- Asrar Alahamadi, MBBS
- Telefonnummer: 614-293-6786
- E-mail: Asrar.Alahmadi@osumc.edu
-
Ledende efterforsker:
- Asrar Alahmadi, MBBS, MAS-CR
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The sample population will include adult patients with relapsed small cell lung cancer (SCLC) receiving care at The Ohio State University Comprehensive Cancer Center - James Cancer Hospital (OSUCCC - The James).
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Confirmed pathologic diagnosis of active SCLC or neuroendocrine cancer.
- Relapsed small cell lung cancer (SCLC) planning to receive commercial DLL3 bispecific T cell engager.
- Willing to provide informed consent.
- Willing to provide blood samples and undergo tissue biopsy at various time points throughout the study, collected in concurrence with treatment cycles and/or imaging visits
- Patients with multiple primary malignancies, recurrent lung cancer, or mixed histology are not excluded.
- Patients who have contraindications or are unable to receive immunotherapy will be eligible for the study, and their samples will be used for comparison and control.
Exclusion Criteria:
- Prisoners or incarcerated patients
- Those with cognitive impairments lacking decision-making capacity are excluded.
- There will be no specific restrictions with respect to performance status, organ function, or prior/concurrent modes of therapy other than that the patient must be able to tolerate venipuncture and any planned interventional radiology or surgical procedures deemed necessary by their treating physicians.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Relapsed SCLC Patients
Blood and tissue samples will be collected at baseline, during treatment, and at disease progression, in concordance with routine clinical visits and imaging assessments.
|
Undergo blood and tissue sample collection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of obtaining paired tumor samples and serial blood collection
Tidsramme: Up to 3 years
|
The feasibility rate is defined as the proportion of enrolled patients who obtained paired pre- and post-treatment biopsies with good quality (≥30% cellularity) and were compliant with serial blood samples collection
|
Up to 3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Investigator-assessed objective response rate (ORR)
Tidsramme: Up to 3 years
|
The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
|
Up to 3 years
|
|
Progression-free survival (PFS
Tidsramme: Up to 3 years
|
The time from treatment initiation until disease progression or death from any cause
|
Up to 3 years
|
|
Overall survival (OS)
Tidsramme: Up to 3 years
|
The time from treatment initiation until death from any cause
|
Up to 3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Asrar Alahmadi, MBBS, MAS-CR, Ohio State University Comprehensive Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. november 2026
Primær færdiggørelse (Anslået)
31. december 2028
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
26. august 2026
Først indsendt, der opfyldte QC-kriterier
26. august 2026
Først opslået (Faktiske)
31. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OSU-25319
Plan for individuelle deltagerdata (IPD)
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