Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy
Palabras clave
Abstracto
Descripción
Predictable risks The study will involve no increased risk or additional discomfort. Blood samples used in the study will be taken at blood samplings scheduled by the hospital practice of the reference institution. Only small amounts of blood will be taken for this study and they will have no repercussion on the patient's general status.
Evaluation of the expected results Improved knowledge of ID epidemiology in patients receiving chemotherapy would enable more effective targeting of potential patients specifically requiring management by injectable iron.
Expected benefits
Through the medium of this study :
- We hope to optimize ID screening, increase our knowledge of ID characteristics and enhance patient management.
- Management of anemia in the cancer setting could thus be modified, i.e. via injectable iron treatment involving no EPO, the dangers of which (increase in the number of thromboembolic events, and even its potentially negative impact on survival) are being more and more fully documented.
- Patients included in this study will benefit from the detection of ID, which otherwise would not have been discovered.
fechas
Verificado por última vez: | 10/31/2015 |
Primero enviado: | 09/30/2013 |
Inscripción estimada enviada: | 10/19/2013 |
Publicado por primera vez: | 10/23/2013 |
Última actualización enviada: | 07/24/2016 |
Última actualización publicada: | 07/25/2016 |
Fecha de inicio real del estudio: | 08/31/2013 |
Fecha estimada de finalización primaria: | 11/30/2015 |
Fecha estimada de finalización del estudio: | 03/31/2016 |
Condición o enfermedad
Intervención / tratamiento
Other: Iron status follow up
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
No Intervention: Iron status follow up | Other: Iron status follow up |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: 1. Patients aged over 18 years of age. 2. Patients with a locally advanced or metastatic solid cancer (breast, colorectal, prostate, ENT, and lung) scheduled to receive first-line chemotherapy for metastatic disease or Patients with a lymphoma-type hematologic cancer scheduled for first-line chemotherapy 3. Patients who have read the information leaflet and have signed the informed consent. 4. Patients covered by national medical insurance. Exclusion Criteria: 1. Patients currently undergoing chemotherapy 2. Patients with diagnosed ID 3. Patients having received oral iron or injectable iron treatment during the previous 3 months 4. Patients receiving EPO or transfused during the 3 months prior to inclusion. 5. Patients unable to give their consent. 6. Patients over 18 but under guardianship or public guardianship. 7. Vulnerable individuals as defined by article L1121-5 to -8 |
Salir
Medidas de resultado primarias
1. ID, whether absolute or functional, shall be defined according to the recommendations contained in NCCN 2012 (NCCN - Practice Guidelines in Oncology - version 2.2012) [2015, december]
Medidas de resultado secundarias
1. Incidence of ID during chemotherapy treatment at W6-W8 and W12-W14 [December 2015]
2. Changes in iron status in cancer patients receiving chemotherapy during W12-W14 [2015, december]
3. Determination of the proportion of patients likely to benefit from injectable iron treatment [2015, december]
4. Characterization of the different iron parameters (hepcidin, chrome and soluble transferrin receptors) in order to define ID in the cancer setting [2015, december]
5. Determination of the proportion of patients classified according to 4 categories (Q1,Q2,Q3,Q4) using the graph proposed by Steinmetz to assist prescribers when prescribing EPO and/or injectable iron [2015, december]
6. Determination of cancer pathologies and/or treatments predictive of occurrence of ID [2015, december]
7. Determination of the existence of a correlation between response to chemotherapy treatment and the presence of ID [2015, december]