Solid Tumor, AdultRET-HENCT03656172
Interest of Reticulocyte Haemoglobin Content (RET-he) in Management of Functional Anemia for Patient With Solid Tumor
An observational study of Solid Tumor, Adult and Anemia Deficiency, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Anemia Deficiency
- What is being tested?
- Haemoglobin measure
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2017to 11 May 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with anaemia treated at the ICO for a solid tumour, not treated or treated with chemotherapy and/or radiotherapy and/or surgery, having benefited before the inclusion of a blood test including an 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Value of Reticulocyte Haemoglobin Content (RET-he) in the Management of Functional Martial Deficiency Anaemia in Patients With Solid Tumours
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.
Read the 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.
- Conditions
- Solid Tumor, Adult, Anemia Deficiency
- Being tested
- Haemoglobin measure
- Keywords
- Anemia by functional martial deficiency, RET-He
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemoglobin measureBiological
Haemoglobin measure before and one month after standard iron treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Haemoglobin measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman Correlation Coefficient Between RET-He at Baseline and Hemoglobin at 1 Month After Intravenous Iron Treatment
Spearman correlation between RET-He measured at baseline (initial blood test) and hemoglobin level measured 1 month after intravenous iron treatment.
Measured: 1 month after inclusion
Secondary outcomes (1)
Percentage of Participants With Hemoglobin Increase ≥1 g/dL 1 Month After Intravenous Iron Treatment (With or Without Erythropoiesis-stimulating Agent)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start4 May 2017
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde DUPE, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656172
- Sponsor's protocol ID
- ICO-N-2017-01
- Acronym
- RET-HE
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2018
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No