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SCLC-OMICS: Proteomics in Small Cell Lung Cancer

Sponsor
Aalborg University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05623956
Collaborator
(none)
50
Enrollment
26
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors.

    The blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy.

    Imaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Identification and validation of protein biomarkers [3 years]

      For identification and validation of protein biomarkers both untargeted and targeted proteomics will be performed, including a discovery-based bottom-up mass spectrometry approach and label-free Quantification Nano Liquid Chromatography Tandem Mass Spectrometry (LFQ nLC-MS/MS), enzyme-linked immunosorbent assay (ELISA)-based proteomics, and Western Blot analyses.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Written and signed informed consent

    • Histopathologically and/or cytologically newly-diagnosed SCLC

    • Measurable disease on CT scans

    • Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide

    Exclusion Criteria:

    • Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ

    • Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ

    • Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed)

    • Treatment with any other investigational agent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aalborg University Hospital

    Investigators

    • Principal Investigator: Weronika Szejniuk, MD, PhD, Aalborg University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weronika Maria Szejniuk, MD, PhD, Aalborg University Hospital
    ClinicalTrials.gov Identifier:
    NCT05623956
    Other Study ID Numbers:
    • N-20220023
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weronika Maria Szejniuk, MD, PhD, Aalborg University Hospital
    Proteomics
    Biomarkers
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Nov 21, 2022