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- Registre américain des essais cliniques
- Essai clinique NCT07848997
METEL Study Which is to Collect Urine Samples From Patients to Analyse Their Chemistry to Assess How Close to Death the Patient is at Point of Sample When They Have a Solid Cancer Tumour Diagnosis (METEL)
Metabolic Changes at End of Life
Use of samples from patients with solid cancer tumour diagnosis to assess chemistry
Aperçu de l'étude
Statut
Les conditions
Description détaillée
We do not know how people die from cancer. In the last two weeks of life, there is evidence for deranged respiratory and renal function variables (2), although few patients have evidence of organ failure. Pulmonary embolus and infection are thought to be the major causes of death based on post-mortem studies (3, 4). However, it is unusual for people with cancer to die suddenly as anticipated from a pulmonary embolus. About a third of patients with advanced cancer admitted to specialist palliative care units have a femoral deep vein thrombosis. Therefore, thromboembolism is considered a manifestation of advanced disease, rather than a cause of premature death (5). There is also a difference between the physiological deterioration leading to death in the acutely unwell patient compared to people dying from cancer (2); there is no evidence of sepsis in those with cancer (6).
This suggests cancer patients generally do not die from organ failure and in those that die with an infection or pulmonary embolus; they die with them, rather than from these events.
A systematic review of biomarkers associated with dying identified common themes in cancer patients, irrespective of the type of malignancy: systemic inflammation, haematological changes, cachexia, hepatic dysfunction, renal dysfunction, and electrolyte changes. (7). Given the common features shared in patients dying from cancer, a "dying process" has been proposed (7) but has not yet been described.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Seamus Coyle Principal Investigator
- Numéro de téléphone: 0151 556 5060
- E-mail: s.coyle@liverpool.ac.uk
Lieux d'étude
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Merseyside
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Liverpool, Merseyside, Royaume-Uni, L7 8YA
- Recrutement
- Clatterbridge Cancer Centre
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Contact:
- Seamus Coyle Coyle
- Numéro de téléphone: 0151 556 5060
- E-mail: s.coyle@liverpool.ac.uk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients with a solid tumour cancer diagnosis
La description
Inclusion Criteria:
- Must have as solid cancer tumour diagnosis Must be over the age of 18 Must be able to understand and communicate in English Must be able to provide fully informed consent at the point of trial entry Must be able to urinate freely or be catheterised
Exclusion Criteria:
- Does not have a solid cancer tumour diagnosis Under the age of 18 Unable to communicate and understand English Unable to provide fully informed consent at the point of trial entry Is no cathetherised or able to urinate freely
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
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Solid Tumour Cancer
Solid Tumour Cancer |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Study Outcome
Délai: 18 months
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This work could identify mechanisms involved in the dying process and develop test predicting time until death. Understanding of the biology of dying will improve the recognition of people in the last days and weeks of life. This will; - - Improve the quality of a person's death by reducing uncertainty and facilitating preferred place of care. Reduce healthcare spending on futile diagnostic and therapeutic interventions. We will correct urine samples once per week from participants, to be able to analyse their metabolites for changes towards end of life. |
18 months
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 337603
- 337603 (Autre identifiant: IRAS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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