Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693952
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : September 26, 2012
Last Update Posted : September 1, 2014
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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 or disease Intervention/treatment Phase
Sepsis in Neutropenic Patients Biological: blood draw Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach.
Study Start Date : May 2012
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: blood samples Biological: blood draw

Primary Outcome Measures :
  1. blood samples [ Time Frame: 3 YEARS ]
    transcriptomic profile identification

Secondary Outcome Measures :
  1. blood samples [ Time Frame: 3 YEARS ]
    the observed profile in patients developing fever and sepsis in comparison with patients not developing such complications

  2. blood samples [ Time Frame: 3 YEARS ]
    the prediction, for each patient, a transcriptomic signature linked to a higher risk developing a sepsis.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01693952


Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: laure farnault    04 91 38 41 53   
Principal Investigator: laure farnault         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01693952     History of Changes
Other Study ID Numbers: 2012-A00322-41
2012-08 ( Other Identifier: AP HM )
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes