Proteomics in Small Cell Lung Cancer | NCT05623956

Studies
Proteomics in Small Cell Lung Cancer

NCT05623956

Sponsor

Aalborg University Hospital

Status

Recruiting

Last Update Posted

Jan 31, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Small Cell Lung Cancer

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Nov 14, 2022

First Submission Date that Met QC Criteria

Nov 14, 2022

First Posted Date

Nov 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2025

Last Update Posted Date

Jan 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Borgen Dalsgaard	Contact	97606989		anbd@rn.dk

Overall Officials

Name	Affiliation	Role
Weronika Szejniuk, MD, PhD	Aalborg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital	Recruiting	Aalborg	Region North Jutland	9000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055752	Small Cell Lung Carcinoma

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided