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

March 31, 2023 updated by: Maastricht University Medical Center

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

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

Study Locations

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 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

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

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
Time Frame: 5 days prior to surgery
units: % per day
5 days prior to surgery
Lung tissue fractional synthetic rate
Time Frame: 5 days prior to surgery
units: % per day
5 days prior to surgery
Muscle tissue fractional synthetic rate
Time Frame: 5 days prior to surgery
units: % per day
5 days prior to surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

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 (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

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

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.

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