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Trial record 1 of 7 for:    monalisa
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Genetic Susceptibility and Biomarkers in Listeriosis (MONALISAGENBIO)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT02924220
First received: October 3, 2016
Last updated: August 1, 2017
Last verified: August 2017
  Purpose

Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%. A better knowledge on the factors involved in its occurrence and in clinical manifestations is therefore needed to improve outcome.

A number of frequent acquired risk factors for listeriosis have been identified, such as pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no genetic study on host susceptibility to listeriosis in humans has been performed so far, in the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is based on Lm culture from clinical samples. This method lacks sensitivity, and the contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated.

The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is the first national case-control prospective study on listeriosis. It is implemented since 2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each patient clinical and biological data and biological samples. Controls with comparable background and presentation are also included. 818 cases have been included (427 S, 252 CNS and 107 MN) over 3.5 years, along with 456 controls.

The aim of the study is to identify human genetic susceptibility factors to listeriosis, biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help improve management of patients with listeriosis.

Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing; biomarkers a identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling.


Condition
Listeriosis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Genetic Susceptibility and Biomarkers in Listeriosis (MONALISA-GENBIO)

Resource links provided by NLM:


Further study details as provided by Institut Pasteur:

Primary Outcome Measures:
  • Characterisation of genetic susceptibility markers for infection as a whole and for each form and/or for the severity of infection [ Time Frame: 3 years ]
    Characterisation of genetic susceptibility markers for infection as a whole and for each form and/or for the severity of infection by whole exome sequencing and whole genome genotyping for all MONALISA cases and controls


Secondary Outcome Measures:
  • Biomarkers identification in serum and plasma of patients and controls [ Time Frame: 3 years ]

    Biomarkers identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling:

    -Characterisation of a biological signature of listeriosis as a whole and for each form of infection.


  • Biomarkers identification in serum and plasma of patients and controls [ Time Frame: 3 years ]

    Biomarkers identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling:

    -Characterisation of the severity of infection (prognosis): death, fetal loss, neurological persisting impairment.



Biospecimen Retention:   Samples With DNA
Biological samples (serum, plasma, mononuclear cells and DNA) previously collected from cases patients and control patients included in the MONALISA cohort.

Estimated Enrollment: 1274
Actual Study Start Date: February 16, 2017
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case patients

Patients with culture-proven listeriosis. Case patients are classified in 3 groups :

  • Septicemic infections: isolation of Lm in blood cultures.
  • CNS infections: isolation of Lm in cerebrospinal fluid, or brain stereotaxic biopsy, or by isolation of Lm in the blood with concomitant meningitis, or radiological encephalitis, rhombencephalitis, brain abscess or meningitis.
  • MF infections: defined by isolation of Lm in any maternal/fetal/neonatal bacteriological sample.

All patients have given their written consent to participate in the MONALISA cohort and for the collection of a blood sample including DNA samples for DNA analyses will be included in the MONALISA GENBIO study.

Control patients

Patients without listeriosis but compatible clinical presentation. Control patients are divided in 3 groups.

  • Septicemic controls: febrile patient with same co-morbidities as septicemic cases.
  • CNS controls: patient with any neurological symptom leading to the empiric prescription of amoxicillin at meningeal dosage because of listeriosis presumption.
  • MF controls: febrile pregnant patient without obvious focal infection.

All patients have given their written consent to participate in the MONALISA cohort and for the collection of a blood sample including DNA samples for DNA analyses will be included in the MONALISA GENBIO study.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients already recruited in the MONALISA study will be included. The MONALISA study is the first prospective case-control study focused on invasive listeriosis. Cases are patients with culture-proven listeriosis. Controls are patients without listeriosis but compatible clinical presentation.
Criteria

Inclusion Criteria:

  • All patients have given their written consent to participate in the MONALISA cohort and for the collection of a blood sample including DNA samples for DNA analyses.

Exclusion Criteria:

  • Patients included in the MONALISA cohort without biological sample available.
  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: NCT02924220

Locations
France
Institut Pasteur, Unité de Biologie des Infections
Paris, France, 75724 Cedex 15
Sponsors and Collaborators
Institut Pasteur
Icahn School of Medicine at Mount Sinai
Investigators
Study Director: Marc Lecuit Institut Pasteur
  More Information

Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT02924220     History of Changes
Other Study ID Numbers: 2016-038
ID-RCB number : 2016-A00650-51 ( Other Identifier: French national registration number of the study )
Study First Received: October 3, 2016
Last Updated: August 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Listeriosis
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 21, 2017