- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Seamus Coyle Principal Investigator
- Telefonnummer: 0151 556 5060
- E-post: s.coyle@liverpool.ac.uk
Studieorter
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Merseyside
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Liverpool, Merseyside, Storbritannien, L7 8YA
- Rekrytering
- Clatterbridge Cancer Centre
-
Kontakt:
- Seamus Coyle Coyle
- Telefonnummer: 0151 556 5060
- E-post: s.coyle@liverpool.ac.uk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patients with a solid tumour cancer diagnosis
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Solid Tumour Cancer
Solid Tumour Cancer |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Study Outcome
Tidsram: 18 months
|
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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 337603
- 337603 (Annan identifierare: IRAS)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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