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A Prospective Registry for Febrile Events in Patients With Malignant Hemopathies or Subjected to Haematopoietic Stem Cell Transplant (HEMA E-CHART)

This study has been completed.
Sponsor:
Collaborator:
Pagano L, Aversa F, Locatelli F, Nosari A,Rossi G, Viale P
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01069887
First received: February 16, 2010
Last updated: February 23, 2010
Last verified: April 2009
  Purpose

Hema e-chart is an electronic case record that can be changed in real time and is based on the chronological organisation of the infective events and the therapies prescribed. It allows the collection of all personal, epidemiological, diagnostic and therapeutic data pertaining to the patient, processing it and analysing the results.

Aims and objectives of the project

The aims of this registry are:

  • To assess how many suspected fungal-related febrile episodes identify an infective fungal agent
  • To have a clear view of the diagnostic and therapeutic actions in the management of onco-haematological patients with suspected fungal-related febrile episodes
  • To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant planning
  • Perform drug-epidemiology relationship analyses, observe toxicity and interactions with antifungal therapies by means of the creation of a national database of fungal infections in patients affected by malignant haemopathies

Design

  • A multicentre, prospective registry for monitoring invasive fungal infections in onco-haematological patients
  • Registration criteria: patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes . The recording of consecutive febrile events is required
  • Data collection for each individual patient will be performed according to the method shown in the enclosed flow chart. In the case of a new episode for an existing patient, said new episode will be recorded in the same case record as a new event. All collected data will be coded into the database
  • Information relating to about 500 suspected fungal-related febrile events requiring antifungal therapy is expected to be collected from approximately 60 centres over the course of 18 months
  • Data collection for each event may be performed following the provision of written informed consent, which will be obtained from each patient participating in this health survey
  • The data collected will be handled and stored in full compliance with the Italian laws governing privacy
  • Hema e-chart is a non-interventional registry

Condition
Hematological Malignancies
Stem Cell Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Multicentre Prospective Registry to Monitor the Incidence of Invasive Fungal Infections and to Monitor the Diagnostic and Therapeutic Management of Suspected Fungal-related Febrile Episodes in Patients With Malignant Hemopathies or Subjected to Haematopoietic Cell Transplant for the Treatment of Onco-haematological Diseases (HEMA E-CHART REGISTRY)

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • number of febrile events [ Time Frame: 3 times/week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of invasive fungal infections [ Designated as safety issue: No ]

Enrollment: 3000
Study Start Date: March 2007
Study Completion Date: March 2009
Groups/Cohorts
adult with hematological malignancies
pediatrics with hematological malignancies
pediatrics receiving stem cell transplant
adult receiving stem cell transplant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes

Criteria

Inclusion Criteria:

  • patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069887

Locations
Italy
Hematology Institute - Catholic University
Rome, RM, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Pagano L, Aversa F, Locatelli F, Nosari A,Rossi G, Viale P
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01069887     History of Changes
Other Study ID Numbers: 578/06
Study First Received: February 16, 2010
Last Updated: February 23, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
febrile events
invasive fungal infections
hematological patients

ClinicalTrials.gov processed this record on November 23, 2014