Lung Cancer Surgery in Sarcopenia Patients With Old Age (LUCAS-PEN)
10 mai 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
400
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Kwon Joong Na, MD
- Numéro de téléphone: 82-10-3329-9392
- E-mail: kjna85@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Su Ji Kim
- Numéro de téléphone: 82-10-2988-8207
- E-mail: k_s.j@snu.ac.kr
Lieux d'étude
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Seoul, Corée, République de, 03080
- Recrutement
- Seoul National University Hospital
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Contact:
- Kwon Joong Na, MD
- Numéro de téléphone: 82-10-3329-9392
- E-mail: kjna85@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
70 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients above the age of 70 who are planning to undergo curative surgery for proven lung cancer or pulmonary nodules suspected for lung cancer
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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overall survival
Délai: 5 years after the day of lung cancer surgery
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survival status during the follow-up after the lung cancer surgery
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5 years after the day of lung cancer surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
recurrence free survival
Délai: up to 5 years after the day of lung cancer surgery
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any recurrence or death during the follow-up after the lung cancer surgery
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up to 5 years after the day of lung cancer surgery
|
|
non-cancer related mortality
Délai: up to 5 years after the day of lung cancer surgery
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any death not related to lung cancer during the follow-up after the lung cancer surgery
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up to 5 years after the day of lung cancer surgery
|
|
postoperative change of pulmonary function
Délai: at postoperative 1 year, 5 year
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pulmonary function during the follow-up after the lung cancer surgery
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at postoperative 1 year, 5 year
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postoperative complication rate
Délai: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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complication after lung cancer surgery
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from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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operative mortality
Délai: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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mortality related to lung cancer surgery
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from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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length of stays
Délai: from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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length of hospital stays after lung cancer surgery
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from the day of lung cancer surgery to the discharge after lung cancer surgery (up to 6 months)
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|
quality of life questionnaire
Délai: before the surgery, at postoperative 1 year, and at postoperative 5 year
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EQ-5D-5L (5-level European quality of life Five Dimension)
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before the surgery, at postoperative 1 year, and at postoperative 5 year
|
|
quality of life questionnaire
Délai: before the surgery, at postoperative 1 year, and at postoperative 5 year
|
EQ-VAS (European quality of life visual analogue score)
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before the surgery, at postoperative 1 year, and at postoperative 5 year
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geriatric depression scale questionnaire
Délai: before the surgery, at postoperative 1 year, and at postoperative 5 year
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Korean version geriatric depression scale (0-15, higher number indicates normal mood)
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before the surgery, at postoperative 1 year, and at postoperative 5 year
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cognitive function questionnaire
Délai: before the surgery, and at postoperative 5 year
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Korean version Montreal Cognitive Assessment
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before the surgery, and at postoperative 5 year
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: In Kyu Park, MD, PhD, Seoul National University Hospital, Department of Thoracic and Cardiovascular Surgery
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 avril 2021
Achèvement primaire (Anticipé)
30 juin 2023
Achèvement de l'étude (Anticipé)
30 juin 2028
Dates d'inscription aux études
Première soumission
20 avril 2022
Première soumission répondant aux critères de contrôle qualité
20 avril 2022
Première publication (Réel)
26 avril 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 mai 2022
Dernière vérification
1 mai 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Manifestations neurologiques
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Manifestations neuromusculaires
- Conditions pathologiques, anatomiques
- Atrophie musculaire
- Atrophie
- Tumeurs pulmonaires
- Sarcopénie
Autres numéros d'identification d'étude
- 800-20210011
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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