Interest of Reticulocyte Haemoglobin Content (RET-he) in Management of Functional Anemia for Patient With Solid Tumor (RET-HE)
Investigating the Value of Reticulocyte Haemoglobin Content (RET-he) in the Management of Functional Martial Deficiency Anaemia in Patients With Solid Tumours
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 blood test 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 blood test 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 blood test 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Saint-Herblain, France, 44805
- Institut de Cancérologie de l'Ouest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Haemoglobin measure before and one month after standard iron treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spearman Correlation Coefficient Between RET-He at Baseline and Hemoglobin at 1 Month After Intravenous Iron Treatment
Time Frame: 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.
|
1 month after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants With Hemoglobin Increase ≥1 g/dL 1 Month After Intravenous Iron Treatment (With or Without Erythropoiesis-stimulating Agent)
Time Frame: 1 month
|
Percentage of participants achieving a hemoglobin increase of ≥1 g/dL from baseline to 1 month after intravenous iron treatment, with or without erythropoiesis-stimulating agent.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathilde DUPE, MD, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-N-2017-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.