Interest of Reticulocyte Haemoglobin Content (RET-he) in Management of Functional Anemia for Patient With Solid Tumor

NCT03656172 | Completed

• 1 other identifier: ICO-N-2017-01
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Solid Tumor, Adult; Anemia Deficiency

Keywords

Anemia by functional martial deficiency; RET-He

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

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.

Biological: Haemoglobin measure

Interventions

Haemoglobin measure BIOLOGICAL

Haemoglobin measure before and one month after standard iron treatment

Haemoglobin measure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

Location

Study Officials

• Mathilde DUPE, MD

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 4, 2018
• Study Start: May 4, 2017
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

FR (1)