- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05346185
Lung Cancer Surgery in Sarcopenia Patients With Old Age (LUCAS-PEN)
10. mai 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kwon Joong Na, MD
- Telefonnummer: 82-10-3329-9392
- E-post: kjna85@gmail.com
Studer Kontakt Backup
- Navn: Su Ji Kim
- Telefonnummer: 82-10-2988-8207
- E-post: k_s.j@snu.ac.kr
Studiesteder
-
-
-
Seoul, Korea, Republikken, 03080
- Rekruttering
- Seoul National University Hospital
-
Ta kontakt med:
- Kwon Joong Na, MD
- Telefonnummer: 82-10-3329-9392
- E-post: kjna85@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
70 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients above the age of 70 who are planning to undergo curative surgery for proven lung cancer or pulmonary nodules suspected for lung cancer
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
overall survival
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
recurrence free survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
quality of life questionnaire
Tidsramme: before the surgery, at postoperative 1 year, and at postoperative 5 year
|
EQ-5D-5L (5-level European quality of life Five Dimension)
|
before the surgery, at postoperative 1 year, and at postoperative 5 year
|
quality of life questionnaire
Tidsramme: before the surgery, at postoperative 1 year, and at postoperative 5 year
|
EQ-VAS (European quality of life visual analogue score)
|
before the surgery, at postoperative 1 year, and at postoperative 5 year
|
geriatric depression scale questionnaire
Tidsramme: 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
Tidsramme: before the surgery, and at postoperative 5 year
|
Korean version Montreal Cognitive Assessment
|
before the surgery, and at postoperative 5 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: In Kyu Park, MD, PhD, Seoul National University Hospital, Department of Thoracic and Cardiovascular Surgery
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. april 2021
Primær fullføring (Forventet)
30. juni 2023
Studiet fullført (Forventet)
30. juni 2028
Datoer for studieregistrering
Først innsendt
20. april 2022
Først innsendt som oppfylte QC-kriteriene
20. april 2022
Først lagt ut (Faktiske)
26. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 800-20210011
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Lungekreft
-
Yonsei UniversityFullført
-
Novartis PharmaceuticalsFullførtNevroendokrine svulster | Avansert NET av GI Origin | Advanced NET of Lung OriginForente stater, Colombia, Italia, Taiwan, Storbritannia, Belgia, Tsjekkia, Tyskland, Japan, Saudi-Arabia, Canada, Nederland, Spania, Korea, Republikken, Libanon, Østerrike, Kina, Hellas, Sør-Afrika, Thailand, Ungarn, Tyrkia, Polen, Slov... og mer
-
The Cleveland ClinicTilbaketrukketOne Lung Ventillation (OLV) | To lungeventilasjon (TLV) | Positivt End Expiratory Pressure (PEEP) | Null sluttekspirasjonstrykk (ZEEP)
-
Assiut UniversityHar ikke rekruttert ennåLungekreft | Lungeskade | Bleb Lung
-
RenJi HospitalRekrutteringMultiple Synchronous Lung Cancers (MSLC)Kina
-
Poitiers University HospitalFullførtEndobronchial Transbronchial Needle Aspiration Lung Cancer Procore
-
University of LorraineFullførtBare barn | Spontan pneumothorax | Idiopatisk pneumotoraks | Bleb LungFrankrike
-
AHS Cancer Control AlbertaCross Cancer InstituteFullførtOmfattende Stage Small Cel Lung CancerCanada
-
Damascus UniversityUniversity Children's HospitalFullførtEsophageal atresi | One Lung Ventilation OLV | Hydrocystoma | Pneumonektomi | Pleura; AbscessDen syriske arabiske republikk
-
Ministry of Health, Saudi ArabiaHar ikke rekruttert ennåLuftveissykdom | Prematuritet | Ventilator Lung; Nyfødt