Prevalence of Functional Iron Deficiency (FID) and Quality of Life (QoL) in Patients with Oncological and with Haematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies.
研究概览
简要总结
Prospective single-center observational study assessing prevalence of FID (Laboratory work-up) and Quality of Life (Questionnaire) in adult patients with oncological and with haematological malignancies within four weeks prior to disease-directed therapy.
详细描述
Patients included into the study will have a laboratory work-up assessing the occurence of functional iron deficiency using laboratory parameters (full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP, ALAT) and have to fill in once the FACT-An questionnaire generating data on Quality of Life at time of study entry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age > 18 years
- •Patients with oncological (solid tumors) and with haematological malignancies (non-solid tumors, including Plasma cell myeloma, lymphoma, myeloproliferative neoplasias [MPN], myelodysplastic syndromes [MDS] and chronic leukemias)
- •Within four weeks prior to disease-directed systemic therapy
- •Participation in other trials is possible
排除标准
- •Known iron deficiency with or without iron substitution p.o. or i.v. within last 8 weeks prior to inclusion into this trial
- •Therapy with RBC-transfusions within last 8 weeks prior to inclusion into this trial
- •Therapy with ESA within last 8 weeks prior to inclusion into this trial
- •Malignancies with acute need for therapeutic intervention (e.g. acute leukemias, superior vena cava obstruction, etc.)
- •Pregnancy
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the trial
- •Inability to give consent
结局指标
主要结局
The primary endpoint is the determination of the prevalence of FID in patients with oncological and with haematological malignancies.
时间窗: through study completion, an average of 1 year
Prevalence of functional iron deficiency in the study population using full blood count, reticulocytes, transferrin saturation, serum-ferritin, CRP and ALAT.
次要结局
- The secondary endpoint is the collection of data on quality of life using FACT-An.(through study completion, an average of 1 year)
研究者
Axel Rüfer, MD
Co-Head Physician
Luzerner Kantonsspital