Proteomics in Small Cell Lung Cancer (SCLC-OMICS)
January 28, 2025 updated by: Weronika Maria Szejniuk, Aalborg University Hospital
Circulating Metabolites and Tumor-derived Extravesicular Proteins 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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Borgen Dalsgaard
- Phone Number: 97606989
- Email: anbd@rn.dk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weronika Szejniuk, MD, PhD, Aalborg University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 14, 2022
First Posted (Actual)
November 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 28, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20220023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.