NCT05794529

Brief Summary

The current study will recruit lung cancer patients to measure tissue protein synthesis rates of non-small cell lung carcinomas and healthy lung tissue. The protein synthesis rates of healthy lung tissue will be compared to lung tumor tissue to establish the remodeling characteristics of healthy versus cancerous lung tissues. We will also examine whether tissue protein synthesis rates of non-small cell lung carcinomas are associated with various tumor- (i.e., size, subclassification) and patient-derived (i.e., inflammation, lung function, smoking status, and smoking history) parameters.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

March 15, 2023

Last Update Submit

March 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Lung tumor fractional synthetic rate

    units: % per day

    5 days prior to surgery

  • Lung tissue fractional synthetic rate

    units: % per day

    5 days prior to surgery

  • Muscle tissue fractional synthetic rate

    units: % per day

    5 days prior to surgery

Secondary Outcomes (11)

  • Plasma glucose concentrations

    Baseline

  • Plasma insulin concentrations

    Baseline

  • Plasma GH concentrations

    Baseline

  • Plasma IGF-1 concentrations

    Baseline

  • Plasma IGFBP-1 concentrations

    Baseline

  • +6 more secondary outcomes

Study Arms (1)

Lung cancer patient

Lung cancer patients diagnosed a non-small cell lung carcinoma requiring resection surgery.

Other: There are no interventions in the present study

Interventions

There are no interventions in the present study

Lung cancer patient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In total, we will recruit 30 lung cancer patients (diagnosed with a NSCLC) scheduled to undergo surgery. The nature and the risks of the experimental procedures will be explained to all subjects before their informed consent will be obtained. All subjects will be recruited through contact with their Surgeon at the Department of surgery at Zuyderland Medical Centre, Heerlen.

You may qualify if:

  • Aged 18-65 years
  • Compos mentis
  • Diagnosed with lung cancer, with treatment requiring a thoracotomy or VATS lobectomy

You may not qualify if:

  • Neoadjuvant chemo- or radiotherapy in the past four weeks
  • Use of systemic steroids in the past four week
  • Insulin-dependent diabetes mellitus
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuyderland Medical Center

Heerlen, Limburg, 6419 PC, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 3, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share data with other researchers.

Locations