Interest of Hemoglobin Count of Reticulocytes in Management of Functional Anemia for Patient With Solid Tumor (RET-HE)
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|ClinicalTrials.gov Identifier: NCT03656172|
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment|
|Solid Tumor, Adult Anemia Deficiency||Biological: Haemoglobin measure|
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.
The different follow-up points for each patient will be the standard assessments made according to the NCCN recommendations:
- Assessment 1: between J21 (= 3 wk) and J35 (= 5 wk) after the introduction of a treatment (= J0) : the balance sheet must include at least one NFS and reticulocytes with RET-He (carried out in the ICO laboratory). This assessment will allow an intermediate evaluation of the effectiveness of the treatment by the doctor in order to envisage a possible implementation under ASE.
- Assessment 2: between J36 (= 6 wk) and J84 (= 12 wk) after the introduction of a treatment (= J0). The balance sheet must include at least one NFS (carried out in the ICO laboratory).
An exclusion from the protocol will be carried out in a second step if the patient receives a globular pellet transfusion between the initial balance sheet and the assessment 1. The results of the assessment 2 will not be taken into account if the patient has a transfusion between the assessment 1 and the assessment 2.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||80 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Study of the Interest of the Hemoglobin Content of Reticulocytes (RET-he) in the Management of Functional Military-deficient Anemia in the Patient With a Solid Tumor|
|Actual Study Start Date :||June 4, 2017|
|Estimated Primary Completion Date :||January 4, 2020|
|Estimated Study Completion Date :||March 4, 2020|
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 balance (NFS, reticulocytes with RET-He , a martial balance sheet (iron, transferrin and Ferritin), a CRP, vitamins B12 and B9, a creatinine, a haptoglobin, a TSH) before and after iron treatment.
Biological: Haemoglobin measure
Haemoglobin measure before and one month after standard iron treatment
- Hemoglobin content of reticulocytes (RET-He) dosage [ Time Frame: 1 month after inclusion ]Correlation between the value of RET-He on the initial balance sheet and the response to iron treatment IV at 1 month
- Iron anemia dosage [ Time Frame: 3 months after inclusion ]Calculation of the percentage of patients answering to the treatment with iron IV (associated or not to an ASE) in case of functional martial deficiency
- Hypochromic erythrocytes (HYPO-He) dosage [ Time Frame: 3 months after inclusion ]Calculation of the threshold of% HypoHe allowing to obtain a good VPP of martial deficiency and/or a good VPN of absence of deficiency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656172
|Contact: Mathilde DUPE||+33 2 40 67 978 email@example.com|
|Contact: Laëtitia HIMPE||+ 33 2 40 67 97 firstname.lastname@example.org|
|Institut de Cancérologie de l'Ouest||Recruiting|
|Saint Herblain, France, 44805|
|Contact: Mathilde DUPE +33 2 40 67 98 37 email@example.com|
|Study Director:||Mathilde DUPE||Institut de Cancérologie de l'Ouest|