Klinická studie na Kachexie, Nemalobuněčný karcinom plic - Registr klinických hodnocení

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

This is a cross-sectional, non-interventional, European (France and Belgium), multicentric prevalence study, conducted on a representative population of 500 patients with NSCLC, to assess the frequency and the management of cachexia and associated symptoms.

The study will be conducted in accordance with the professional code of ethics and the good epidemiological practices guidelines developed by the ADELF (the Association of French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the drafting of reports and publications related to the study.

The information will be collected during a single visit to the oncologist/lung specialist as part of the usual patient management of his/her lung cancer. The physician will explain the purpose of the study to the patient with an information form specific to the study and will inform him/her of the option to refuse or withdraw from participation. The patient information form in France or a specific consent form in Belgium will be signed by the patient and a copy will be given to him/her (the original will be kept by the physician).

This study does not require any additional specific data. Data will come from the medical file and from the routine disease management. Furthermore, the following self-completion questionnaires will be proposed to patients: Visual analogue scale for dietary intake (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT] questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ, International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be collected for assessment of skeletal muscle mass index at L3.

Typ studie

Pozorovací

Zápis (Aktuální)

539

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Francie
- - Paris, Francie, 92042
    - Chugai Pharma France

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or in-patient hospitalization.

Popis

Inclusion Criteria:

Patient 18 years of age and older
Patient with NSCLC
Patient who has been informed of the study and who has signed a patient information leaflet for France or an informed consent for Belgium
Patient able to complete a self-assessment questionnaire

Exclusion Criteria:

Patient unable to consent and/or unable to sign the patient information form in France or an informed consent in Belgium
Patient with a complete resection of an early stage NSCLC
History of head and neck cancer

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Observační modely: Kohorta
Časové perspektivy: Průřezový

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Frequency of Cachexia According to Modified Fearon Criteria Časové okno: Day1	Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity. A patient was considered to have cachexia if he/she had: Weight loss >5% in the last 6 months prior to inclusion or BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions. In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).	Day1

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Frequency of the Different Stages of Cachexia in the General NSCLC Population Časové okno: Day 1	Percentage of the different stages of cachexia at inclusion. The different stages of cachexia used the following classification: No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]	Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC. Časové okno: Day 1	Percentage of the different stages of cachexia at inclusion according to the NSCLC stage	Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC. Časové okno: Day 1	Percentage of the different stages of cachexia according to the NSCLC histology	Day 1
Frequency of Sarcopenia in the General NSCLC Patients With Cachexia Časové okno: Day 1	Percentage of patients with sarcopenia in the general NSCLC patients with cachexia	Day 1
Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia Časové okno: Day 1	Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:	Day 1
Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC. Časové okno: Day 1	Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC: EGRF, ALK, ROS1, BRAF or HER2 K-RAS No mutation	Day 1
Frequency of the Different Stages of Cachexia According to the Number of Treatments Received. Časové okno: Day 1	NSCLC patients. 84 patients with missing data	Day 1
Frequency of the Different Stages of Cachexia According to the Types of Treatments Received. Časové okno: Day 1	Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State Časové okno: Day 1	• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose Časové okno: Day 1	Blood glucose abnormalities according to the different stages of cachexia at inclusion	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale Časové okno: Day 1	Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT Časové okno: Day 1	Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio Časové okno: Day 1	neutrophil/lymphocyte ratio	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP Časové okno: Day 1	CRP level	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen Časové okno: Day 1	fibrinogen level	Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia. Časové okno: Day 1	Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales	Day 1
Description of the Level of Physical Activity Associated With the Different Stages of Cachexia. Časové okno: Day 1	Three levels of physical activity are defined: - Low No activity is reported OR An activity is reported but does not reach moderate or high levels. - Moderate Corresponds to one of the following 3 criteria: 3 or more days of intense activity lasting at least 20 min per day OR 5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR 5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week - High Corresponds to one of the following 2 criteria: Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR 7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week	Day 1
Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms Časové okno: Day 1	Pharmacological treatment of cachexia or associated symptoms: Yes / No	Day 1
Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms Časové okno: Day 1	Non-pharmacological treatment of cachexia or associated symptoms: Y/N	Day 1
Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments Časové okno: Day 1	Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No	Day 1
Number of Participants With Diabetes Treatments Časové okno: Day 1	Diabetes treatments : Yes/No	Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia Časové okno: Day 1	Proportion of patients with cachexia according to the subjective assessment of the clinician Proportion of patients with cachexia according to the Fearon criteria	Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia Časové okno: Day 1	Proportion of patients with anorexia according to the subjective assessment of the clinician Proportion of patients with anorexia according to the Ingesta VAS Proportion of patients with anorexia according to the AC/S-FAACT module score Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"	Day 1
Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition Časové okno: Day 1	Proportion of patients with severe malnutrition according to the subjective assessment of the clinician Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.	Day 1

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chugai Pharma France

Spolupracovníci

French College of General Hospital Pneumologists (CPHG)

French-Speaking Association of Supportive Care in Cancer (AFSOS)

ITEC Services

Vyšetřovatelé

Ředitel studie: Luz Bobadilla, MD, Chugai Pharma France

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. července 2016

Primární dokončení (Aktuální)

1. října 2016

Dokončení studie (Aktuální)

1. října 2016

Termíny zápisu do studia

První předloženo

17. listopadu 2016

První předloženo, které splnilo kritéria kontroly kvality

18. listopadu 2016

První zveřejněno (Odhad)

21. listopadu 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. září 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. září 2019

Naposledy ověřeno

1. září 2019

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

CPF-ANA-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer. (CacheMire)

Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.