NCT05623956

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 31, 2025

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

November 14, 2022

Last Update Submit

January 28, 2025

Conditions

Keywords

ProteomicsBiomarkers

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, Region North Jutland, 9000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Weronika Szejniuk, MD, PhD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Borgen Dalsgaard

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

March 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 31, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations