Proteomics in Small Cell Lung Cancer

Recruiting

• Conditions: Small Cell Lung Cancer

• Registration Number: NCT05623956
• Lead Sponsor: Aalborg University Hospital

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.

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 Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-21
• Study Start: 2023-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region North Jutland, Denmark