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Trial record 2 of 180 for:    RET

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
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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.

Condition or disease Intervention/treatment
Solid Tumor, Adult Anemia Deficiency Biological: Haemoglobin measure

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 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anaemic adult Patients supported within the ICO for a solid tumor, untreated or treated by chemotherapy and/or radiotherapy and/or surgery, having benefited before the inclusion of a blood balance including an 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.
Criteria

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 balance sheet.
  • Patient who received iron (oral or injectable) in the two months preceding the initial balance sheet (10).
  • Patient who received a transfusion of globular pellets in the month preceding the initial balance sheet.

Information from the National Library of Medicine

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


Contacts
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Contact: Mathilde DUPE +33 2 40 67 978 37 mathilde.dupe@ico.unicancer.fr
Contact: Laëtitia HIMPE + 33 2 40 67 97 47 laetitia.himpe@ico.unicancer.fr

Locations
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France
Institut de Cancérologie de l'Ouest Recruiting
Saint Herblain, France, 44805
Contact: Mathilde DUPE    +33 2 40 67 98 37    mathilde.dupe@ico.unicancer.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
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Study Director: Mathilde DUPE Institut de Cancérologie de l'Ouest

Additional Information:

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Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03656172     History of Changes
Other Study ID Numbers: ICO-N-2017-01
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Cancerologie de l'Ouest:
Anemia by functional martial deficiency
RET-He
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases