Development of a Biomarker Directed Strategy to Ameliorate Common Toxicities From Conventional Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
研究概览
简要总结
Side effects from chemotherapy can be severe in some patients leading to admission to hospital, a worse quality of life and delays in subsequent doses of chemotherapy. A blood test that could predict patients who will go on to develop severe side effects could be useful and might allow early intervention with medicines to reduce the severity of the symptoms and prevent admission to hospital.
This study will collect blood samples from patients with lymphoma or sarcoma who are receiving chemotherapy (with an expected admission rate for neutropenic sepsis, one of the side effects that most commonly results in hospital admission, of less than 20%). It will assess whether changes in blood proteins ("biomarkers") taken 2 days after the 1st chemotherapy can predict subsequent severe side effects throughout the 4 months of chemotherapy. In addition the investigators will collect data on quality of life and contact with medical professionals to assess the costs of chemotherapy toxicity to both the patient and health service. This will allow us in the future to model the cost effectiveness of using biomarkers in this manner to try and reduce chemotherapy toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients with lymphoma or sarcoma identified to receive out-patient chemotherapy with an anticipated febrile neutropenia rate of less than 20%. This would include 21 day R-CHOP in patients under 70 and single agent doxorubicin [Aapro et al, 2011a].
- •Age 18 or older
- •Performance Status 0-2
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
排除标准
- •Past history of HIV, Hepatitis B or C positive, due to the difficulties in handling high-risk specimens within CEP.
- •Major surgery, radiotherapy, chemotherapy or mechanism based agents within the last 4 weeks.
- •Radio-immunotherapy within the last 8 weeks.
- •Bilirubin greater than 1.5 X the upper limit of normal and ALT greater than 2.5 x the upper limit of normal (as disturbed liver function tests are associated with elevated CK18) [Gonzalez-Quintela et al, 2009, Lavallard et al, 2011]
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
结局指标
主要结局
sensitivity and specificity of changes in CK18 and FLT 3 ligand at day 3 of chemotherapy to predict subsequent severe toxicity
时间窗: day 3
to confirm in a prospective cohort whether changes in CK18 and FLT3 ligand at day 3 of chemotherapy can identify patients at risk of subsequent severe chemotherapy toxicity
次要结局
- number of hospital admissions for febrile neutropenia(end of chemotherapy at approximately 6 months)
- Total number of overnight stays or stays in A&E of over 4 hours spent in hospital(End of study chemotherapy at approximately 6 months)
- Dose intensity of chemotherapy achieved compared to planned cumulative dose on initiation of therapy(End of chemotherapy at approximately 6 months)
- Change in QOL at the start of cycles 2, 4 and 6 of chemotherapy and at the end of study as measured by functional assessment of cancer therapy general (FACT-G) and euroqol EQ-5D questionnaires(cycle 2 (week6), 4 (week 12), 6 (week 18) and end of study (approximately 6 months))
- Number of total days delay in receiving chemotherapy treatment compared to planned delivery(end of chemotherapy at approximately 6 months)
- Total number of contacts (both face to face and telephone) with medical and nursing staff including visits to GP, Accident and Emergency, hospital clinics and telephone consultations with Hotline staff of hospital doctors(end of study chemotherapy at approximately 6 months)
研究者
Rebecca Robinson
Clinical Trial Project Manager
The Christie NHS Foundation Trust