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Recruiting

NCT Number: NCT05623956

Proteomics in Small Cell Lung Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital

Aalborg, Region North Jutland, 9000, Denmark

Location status: Recruiting

Location contact

Weronika Maria Szejniuk, MD, PhD

CONTACT

[email protected]

97661524

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification and validation of protein biomarkers

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Borgen Dalsgaard

CONTACT

[email protected]

97606989

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer

Acronym: SCLC-OMICS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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