Investigating the Value of Reticulocyte Haemoglobin Content (RET-he) in the Management of Functional Martial Deficiency Anaemia in Patients With Solid Tumours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- To assess the value of the initial measurement of reticulocyte haemoglobin content (RET-He) in predicting response to martial therapy
研究概览
简要总结
Determine the value of the initial measurement of the hemoglobin content of reticulocytes (RET-He) for predicting the response to martial treatment for patients with a solid tumor with a functional martial deficiency as defined NCCN2016 (with or without inflammation). The aim is to refine the current definition of functional martial deficiency in order to best adapt the iron prescription in oncology by giving iron only if necessary, i.e. if the RET is low.
详细描述
Anemia is a common clinical situation in oncology. It contributes to the asthenia and thus to the decrease in the quality of life of the patient. In addition, it is considered an independent pejorative prognostic factor according to a literature review of 2001. An appropriate management of the latter is therefore paramount. To do this, it is necessary to successfully define its origins.
In 2014, RET-he was studied for the first time in the cancer patient. This analysis showed that there is a good negative predictive value of RET-he for a cut-off of 32 PG, i.e., that above this value the iron deficiency is unlikely. Iron deficiency anemia was defined by hemoglobin below 11 g/dl, serum iron less than 40 Μ g/dl, and TSAT less than 20%. However, this study had some limiting factors. First, patients were not separated according to cancer pathology: solid tumors versus malignant hemic. In addition, previous treatments, such as the administration of ASE, iron and/or globular pellets, have not been taken into account. The number of patients with anemia and iron deficiency was limited (n = 23). Despite these different biases, this study is the first to demonstrate the interest of this parameter in the management of anemia in the patient in oncology.
In total, the data are consistent with the potential interest of the hemoglobin content of reticulocytes in the diagnosis of martial deficiency. This is why the purpose of this project is to establish a RET-He study in anaemic patients with a solid tumor to determine if this endpoint could be included in a diagram of the management of anemia in oncology, particularly for To detect subpopulations (responder patient or not to iron IV) in patients with a functional martial deficiency.
Patients will be included as they are taken care of in the facility. A delay of about 3 months is necessary for the information to be complete and validated. The file will be taken out at regular intervals to inform the patient's follow-up.
The establishment of the therapy to correct anemia (administration of iron IV (associated or not to an ASE) is the responsibility of the referring physician or other prescriber doctor by delegation.
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.
- •Metastatic solid tumor or not.
- •Anemia by functional martial deficiency (as defined in the NCCN2016 recommendations):
- •o Hb < 11 g/DL, TSAT < 20% and ferritinlike between 30 and 800 ng/ml
- •Initial assessment of anemia carried out at the laboratory of Biopathology of the ICO
排除标准
- •Patient with malignant hemopathy.
- •Patient with chronic renal failure with an estimation of renal filtration rate according to the formula CKD-EPI < 60 ml/min/1.73 m².
- •Patient with vitamin B12 deficiency, folate deficiency, hemolysis and/or hemoglobinopathy.
- •Patient with active infection.
- •Patient with bone marrow tumor. Confirmation by a osteo-medullary biopsy (BOM) or a myelogram is not necessary to exclude the patient.
- •Patient who received ASE within two months prior to the initial blood test.
- •Patient who received iron (oral or injectable) in the two months preceding the initial blood test.
- •Patient who received a transfusion of globular pellets in the month preceding the initial blood test.
研究组 & 干预措施
Haemoglobin measure
Anaemic adult Patients eligible to iron Treatment supported within the ICO for a solid tumor, untreated or treated by chemotherapy and/or radiotherapy and/or surgery, having benefited of a blood test (NFS, reticulocytes with RET-He , a martial blood test (iron, transferrin and Ferritin), a CRP, vitamins B12 and B9, a creatinine, a haptoglobin, a TSH) before and after iron treatment.
干预措施: Haemoglobin measure (Biological)
结局指标
主要结局
To assess the value of the initial measurement of reticulocyte haemoglobin content (RET-He) in predicting response to martial therapy
时间窗: 1 month after inclusion
Correlation between the value of RET-He on the initial blood test and the response to intravenous iron treatment at 1 month after start of this treatment.
Spearman Correlation Coefficient Between RET-He at Baseline and Hemoglobin at 1 Month After Intravenous Iron Treatment
时间窗: 1 month after inclusion
Spearman correlation between RET-He measured at baseline (initial blood test) and hemoglobin level measured 1 month after intravenous iron treatment.
次要结局
- Determine whether the percentage Hypo-He parameter, corresponding to the percentage of hypochromic red blood cells (MCHT less than 17 pg), is of interest in the diagnosis of the type of anaemia(3 months after inclusion)
- Assess the effectiveness of therapeutic management of martial deficiency anaemia with Intravenous iron (with or without an ESA: Erythropoiesis-Stimulating Agent)(3 months after inclusion)
- Percentage of Participants With Hemoglobin Increase ≥1 g/dL 1 Month After Intravenous Iron Treatment (With or Without Erythropoiesis-stimulating Agent)(1 month)