Lung Cancer Surgery in Sarcopenia Patients With Old Age (LUCAS-PEN)

January 7, 2026 updated by: In Kyu Park, Seoul National University Hospital

Association of Preoperative Sarcopenia on Postoperative Outcomes After Lung Cancer Surgery: Prospective Observational Study

The presence of sarcopenia before lung resection surgery might be an important factor of short-term and long-term prognosis in lung cancer patients. Through this study, investigators plan to demonstrate evidence whether sarcopenia is a useful clinical biomarker for risk stratification in elderly patients undergoing lung cancer surgery.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Sarcopenia is a syndrome characterized by a decrease in the amount and function of skeletal muscle, and is known to have a prevalence of about 6-10% in 65 years of age or older and about 20-25% in 70 years of age or older. Recently, many studies have been conducted on the clinical importance of sarcopenia, and it has been reported that sarcopenia is significantly associated with a decline in quality of life and physical activity in the elderly population, as well as harmful clinical outcomes in postoperative patients and poor long-term outcomes in various solid cancer patients. Due to the promising result of lung cancer screening trial, lung cancer has been included in national cancer screening in South Korea since last year. As a result, more people are being diagnosed with lung cancer early. Furthermore, the number of patients having surgical resection for lung cancer is steadily growing, and as life expectancy rises, even older patients are increasingly considering surgical treatment. It's critical to appropriately assess risk in older individuals before and after surgery, and sarcopenia is considered a significant fartor for major surgery. According to studies on the association between sarcopenia and the postoperative clinical outcome of lung cancer surgery, sarcopenia evaluated by computed tomography has demonstrated to be associated with a poor surgical outcome and long-term prognosis. However, according to two recognized guidelines for sarcopenia (European Working Group on Sarcopenia in Elder People, and Asian Working Group for Sarcopenia), sarcopenia is supposed to comprehensively evaluate muscle mass, muscle strength, and physical activity. Regarding muscle mass, it is recommended to measure through dual energy-ray absoptiometery or bioelectrial impedance analysis. However, so far, there are no studies that have conducted an accurate evaluation of sarcopenia in elderly lung cancer patients and analyzed the relationship between them and the clinical outcome after lung cancer surgery.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients above the age of 70 who are planning to undergo curative surgery for proven lung cancer or pulmonary nodules suspected for lung cancer

Description

Inclusion Criteria:

  • Patients planning to perform curative surgery for confirmed lung cancer and pulmonary nodules suspected for lung cancer
  • Patients or legal representatives who could understand and write written consent prior to the initiation of the clinical trial and are able to comply with the requirements for the clinical trial

Exclusion Criteria:

  • Patients with treatment history for lung cancer or other solid cancer within 5 years (except patients with adenocarcinoma in situ for lung cancer)
  • Patients who need simultaneous surgery with lung caner surgery for other accompanying diseases
  • Patients who are not eligible to participate in the study judged by the researcher

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years after the day of lung cancer surgery
survival status during the follow-up after the lung cancer surgery
5 years after the day of lung cancer surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence free survival
Time Frame: up to 5 years after the day of lung cancer surgery
any recurrence or death during the follow-up after the lung cancer surgery
up to 5 years after the day of lung cancer surgery
non-cancer related mortality
Time Frame: up to 5 years after the day of lung cancer surgery
any death not related to lung cancer during the follow-up after the lung cancer surgery
up to 5 years after the day of lung cancer surgery
postoperative change of pulmonary function
Time Frame: at postoperative 1 year, 5 year
pulmonary function during the follow-up after the lung cancer surgery
at postoperative 1 year, 5 year
postoperative complication rate
Time Frame: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
complication after lung cancer surgery
from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
operative mortality
Time Frame: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
mortality related to lung cancer surgery
from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
length of stays
Time Frame: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
length of hospital stays after lung cancer surgery
from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
geriatric depression scale questionnaire
Time Frame: before the surgery, at postoperative 1 year, and at postoperative 5 year
Korean version geriatric depression scale (0-15, higher number indicates normal mood)
before the surgery, at postoperative 1 year, and at postoperative 5 year
cognitive function questionnaire
Time Frame: before the surgery, and at postoperative 5 year
Korean version Montreal Cognitive Assessment
before the surgery, and at postoperative 5 year
quality of life questionnaire
Time Frame: before the surgery, at postoperative 1 year, and at postoperative 5 year
Five-level European quality of life Five Dimension (0 - 1, higher score means better outcome)
before the surgery, at postoperative 1 year, and at postoperative 5 year
quality of life questionnaire
Time Frame: before the surgery, at postoperative 1 year, and at postoperative 5 year
European quality of life visual analogue score ( 0 - 100, higher score means a better outcome)
before the surgery, at postoperative 1 year, and at postoperative 5 year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: In Kyu Park, MD, PhD, Seoul National University Hospital, Department of Thoracic and Cardiovascular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 13, 2021

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 800-20210011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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