Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach
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Purpose
Treatment of cancer, and more particularly of haematological malignancies, partly relies on chemotherapy. Most therapeutic regimens display various toxicities, one of the most common being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia can be overcome by haematological growth factors and transfusion, one of the most severe life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major limitation in chemotherapy which is responsible for the majority of treatment-related morbidity and mortality and for prolonged hospitalisation.
In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic patients. While the occurence of neutropenia and sepsis is often unpredictable and thus difficult to study in a prospective way, stem cell transplantation represents a quite convenient model to study such a question. Autologous stem cell transplantation indications in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly, after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by cytapheresis and frozen. When the patient has reached complete remission by conventional chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called "conditioning regimen"). The "conditioning regimen" targeted to have high antitumoral activity leads to a "cytokine storm" resulting in a "programmed inflammation". 36 hours after the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days, until graft becomes "functional". Thus, the timing and duration of neutropenia are very homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus, most patient will be informative regarding sepsis, and there is an easy possibility of biological sampling before" programmed inflammation" (due to conditioning regimen), after inflammation before sepsis, then during and after the sepsis. Since the patient is hospitalized, the kinetic monitoring is quite easy
| Condition | Intervention |
|---|---|
|
Sepsis in Neutropenic Patients |
Biological: blood draw |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach. |
- blood samples [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]transcriptomic profile identification
- blood samples [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]the observed profile in patients developing fever and sepsis in comparison with patients not developing such complications
- blood samples [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]the prediction, for each patient, a transcriptomic signature linked to a higher risk developing a sepsis.
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: blood samples | Biological: blood draw |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- the criteria required to be candidate in an ASCH in our service(department) (age 18 - 66 years, myélome in 1 ° in reply partial line or lymphoma or complete answer after one 2 ° line, absence of preliminary visceral failure).
Informed, willing patients and having given their agreement in writing.
Exclusion Criteria:
- Refusal of the patient
Contacts and Locations| France | |
| Assistance Publique Hopitaux de Marseille | |
| Marseille, France, 13354 | |
| Study Director: | BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT01693952 History of Changes |
| Other Study ID Numbers: | 2012-A00322-41, 2012-08 |
| Study First Received: | May 21, 2012 |
| Last Updated: | September 24, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Sepsis Toxemia Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013