Prove cliniche su Cachessia, Carcinoma polmonare non a piccole cellule - Registro degli studi clinici

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

539

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Francia
- - Paris, Francia, 92042
    - Chugai Pharma France

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: Coorte
Prospettive temporali: Trasversale

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Frequency of Cachexia According to Modified Fearon Criteria Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Frequency of the Different Stages of Cachexia in the General NSCLC Population Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Day 1	neutrophil/lymphocyte ratio	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP Lasso di tempo: Day 1	CRP level	Day 1
Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen Lasso di tempo: Day 1	fibrinogen level	Day 1
Description of the Quality of Life Associated With the Different Stages of Cachexia. Lasso di tempo: 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. Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Day 1	Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No	Day 1
Number of Participants With Diabetes Treatments Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chugai Pharma France

Collaboratori

French College of General Hospital Pneumologists (CPHG)

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

ITEC Services

Investigatori

Direttore dello studio: Luz Bobadilla, MD, Chugai Pharma France

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2016

Completamento primario (Effettivo)

1 ottobre 2016

Completamento dello studio (Effettivo)

1 ottobre 2016

Date di iscrizione allo studio

Primo inviato

17 novembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

18 novembre 2016

Primo Inserito (Stima)

21 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

CPF-ANA-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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.