Lung Tumor Protein Synthesis Rates in Lung Cancer Patients (LungMaas)

Characterizing Tissue Protein Synthesis Rates of Non-small Cell Lung Carcinomas in Lung Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: There are no interventions in the present study

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Andrew Holwerda, PhD; Phone Number: +31433881381; Email: andy.holwerda@maastrichtuniversity.nl

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419 PC
      • Recruiting
      • Zuyderland Medical Center
      • Contact: Erik de Loos, MD; Email: e.deloos@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

1. Aged 18-65 years
2. Compos mentis
3. Diagnosed with lung cancer, with treatment requiring a thoracotomy or VATS lobectomy

Exclusion Criteria:

1. Neoadjuvant chemo- or radiotherapy in the past four weeks
2. Use of systemic steroids in the past four week
3. Insulin-dependent diabetes mellitus
4. Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; There are no interventions in the present study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose concentrations	units: mmol/L	Baseline
Plasma insulin concentrations	units: pmol/L	Baseline
Plasma GH concentrations	units: mU/L	Baseline
Plasma IGF-1 concentrations	units: nmol/L	Baseline
Plasma IGFBP-1 concentrations	units: ug/L	Baseline
Plasma IGFBP-3 concentrations	units: ug/L	Baseline
Plasma CRP concentrations	units: mg/L	Baseline
Plasma IL-1 concentrations	units: ng/L	Baseline
Plasma IL-6 concentrations	units: ng/L	Baseline
Plasma IL-10 concentrations	units: ng/L	Baseline
Plasma TNF-alpha concentrations	units: ng/L	Baseline

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): March 1, 2026
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: METCZ20220060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No