- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Seamus Coyle Principal Investigator
- 전화번호: 0151 556 5060
- 이메일: s.coyle@liverpool.ac.uk
연구 장소
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-
Merseyside
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Liverpool, Merseyside, 영국, L7 8YA
- 모병
- Clatterbridge Cancer Centre
-
연락하다:
- Seamus Coyle Coyle
- 전화번호: 0151 556 5060
- 이메일: s.coyle@liverpool.ac.uk
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with a solid tumour cancer diagnosis
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
Solid Tumour Cancer
Solid Tumour Cancer |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Study Outcome
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 337603
- 337603 (기타 식별자: IRAS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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