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OpenTrials
Active, Not Recruiting

NCT Number: NCT05346185

Lung Cancer Surgery in Sarcopenia Patients With Old Age

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: 5 years after the day of lung cancer surgery

    survival status during the follow-up after the lung cancer surgery

Secondary outcomes

  1. 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

  2. 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

  3. postoperative change of pulmonary function

    Time frame: at postoperative 1 year, 5 year

    pulmonary function during the follow-up after the lung cancer surgery

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. cognitive function questionnaire

    Time frame: before the surgery, and at postoperative 5 year

    Korean version Montreal Cognitive Assessment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: LUCAS-PEN

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 26, 2022
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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