Solid Tumor, Adult Clinical Trial
— RET-HEOfficial title:
Investigating the Value of Reticulocyte Haemoglobin Content (RET-he) in the Management of Functional Martial Deficiency Anaemia in Patients With Solid Tumours
NCT number | NCT03656172 |
Other study ID # | ICO-N-2017-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 4, 2017 |
Est. completion date | May 11, 2020 |
Verified date | April 2021 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 11, 2020 |
Est. primary completion date | May 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
France | Institut de Cancérologie de l'Ouest | Saint Herblain |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the value of the initial measurement of reticulocyte haemoglobin content (RET-He) in predicting response to martial therapy | 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. | 1 month after inclusion | |
Secondary | Assess the effectiveness of therapeutic management of martial deficiency anaemia with Intravenous iron (with or without an ESA: Erythropoiesis-Stimulating Agent) | Calculation of the percentage of patients responding to the treatment with intravenous iron (associated or not to an ESA: erythropoiesis-stimulating agent) in case of functional martial deficiency. | 3 months after inclusion | |
Secondary | 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 | Calculation of the percentage of HypoHe threshold to obtain a good Positive Predictive Value (PPV) of martial deficiency and/or a good Negative Predictive Value (NPV) of no deficiency | 3 months after inclusion |
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