Pharmacogenomics to Improve Supportive Care Symptoms. A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Drug-gene interaction ratio (DGI)
研究概览
简要总结
To understand the clinical utility of multi-gene pharmacogenetic testing in patients receiving palliative and supportive care across palliative care settings (inpatient hospital, outpatient), specifically to calculate a drug-gene interaction ratio, based on extant prescriptions paired with an individual's pharmacogenetic results.
详细描述
This is a prospective, observational cross-sectional study of patients with serious and/or life limiting condition conditions, such as incurable cancer undergoing palliative or supportive care treatment at a University Teaching Hospital in England, UK. Participants will be recruited at point of referral to in-patient or outpatient palliative care services (i.e. at point of presentation with symptom control issues).
All participant study activities:
All participants will undergo testing of a panel of genetic variants relevant to drugs used in symptom control (see https://cpicpgx.org/genes-drugs/ ). This will involve collecting a 5mL blood sample (the intervention) from individuals. All participants will be consented to examination of their records within local hospitals and/or primary care to extract study relevant data (described below).
The start of follow-up will be from the date of the blood sample (the intervention). Standard demographic information including ethnicity will be collected at baseline.
Participation in study will be for the duration of being under palliative care treatment, up to a maximum of 90days from recruitment date.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older; incurable, life limiting condition, clinical care provided at NNUH.
排除标准
- •Lacking capacity to consent to research (unless there is an appropriate consultee)
结局指标
主要结局
Drug-gene interaction ratio (DGI)
时间窗: This will be calculated for all current medications prescribed at the point of recruitment.
The total number of genetic variation results that pair with a relevant prescribed medication for that same individual, divided by total number of individuals tested.
次要结局
- Frequency of changes in prescription medication that are potentially affected by drug-gene interaction(from enrolment until 90 days post blood test)