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NCT05623956 Clinical Trial

Proteomics in Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

— SCLC-OMICS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05623956
Other study ID # N-20220023
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2023
Est. completion date May 2025

Study information
Verified date November 2022
Source Aalborg University Hospital
Contact Borgen Dalsgaard
Phone 97606989
Email anbd@rn.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aalborg University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Identification and validation of protein biomarkers 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. 3 years
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