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Trial record 15 of 42 for:    Recruiting Studies | ITP

Differential Diagnostic of Immune ThrombocytoPenia (ITP) and Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT03469661
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Fundacion CRIS de Investigación para Vencer el Cáncer

Brief Summary:

Current diagnostic criteria for Immune ThrombocytoPenia (ITP) are mainly based on the presence of low numbers of platelets, excluding other multiple causes of thrombocytopenia, including immunodeficiencies, constitutional or acquired thrombocytopenia, hypersplenism and clonal hematological disorders such as MDS, disorders lymphoproliferative and acute myeloid leukemia (AML), among others. The analysis complementary tests for the diagnosis of ITP include studies basic systematic hematology, together with autoimmune assays and microbiological tests, while the evaluation of bone marrow is limited to elderly patients and/or patients resistant to treatment. Previous research has described the development of Myelodysplastic Syndrome (MDS) in patients with a previous diagnosis of ITP, and even the presence of MDS associated with genetic background. Therefore, it is conceivable fact that a percentage of cases with clinical signs of ITP in the moment of appearance may actually correspond to the first stages of MDS development in which bone marrow cells are not systematically evaluated in the initial presentation.

The anomalous immunophenotypic patterns between multiple compartments of bone marrow cells and peripherally blood (PB) platelets have been characterized through flow cytometry. The flow cytometry currently represents an important complementary tool for diagnosis of MDS that has shown great effectiveness and applicability in the differential diagnosis of non-clonal cytopenias against early MDS and for the detection of stages prior to MDS. Besides, the flow cytometry has made it possible to detect the presence of coexisting features related to MDS in patients with other malignancies hematologic conditions such as multiple myeloma, AML, and lymphocytic leukemia chronic. Therefore, the immunophenotypic analysis of the cells of the bone marrow of patients with ITP at the time of appearance would help to identify the cases that underlie clonal hematopoiesis MDS type. In the present study it is planned a broad characterization immunophenotyping of multiple compartments of bone marrow cells and PB platelets from patients with recently diagnosed ITP and investigate their morphological antecedents, in order to identify those patients who show compatible clonal hematopoietic patterns with MDS evident (or at risk of development), as candidates to receive most appropriate therapeutic methods.


Condition or disease
Immune Thrombocytopenia Myelodysplastic Syndromes

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Diagnostic of ITP and MDS: a Prospective Study by Next‐Generation Flow Cytometry and Cytomorphological Approaches
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020


Group/Cohort
Immune Thrombocytopenia Diagnosis
Myelodysplastic Syndrome Diagnosis



Primary Outcome Measures :
  1. Morphological profile [ Time Frame: Baseline ]
    Bone marrow cell compartment profiles

  2. Morphological profile [ Time Frame: Baseline ]
    Peripheral blood platelets profiles

  3. Immunological profile [ Time Frame: Baseline ]
    Bone marrow cell compartment profiles

  4. Immunological profile [ Time Frame: Baseline ]
    Peripheral blood platelets profiles


Secondary Outcome Measures :
  1. Immunophenotypic abnormalities [ Time Frame: Baseline ]
    Evaluation of abnormal immunophenotypic profiles

  2. Morphological abnormalities [ Time Frame: Baseline ]
    Evaluation of abnormal morphological profiles.


Biospecimen Retention:   Samples With DNA
Given a diagnosis of ITP or low-risk MDS, EDTA-anticoagulated bone marrow and peripheral blood aspirates will be obtained per case. A biopsy sample and two unstained blood smears should also be included


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It is estimated that approximately 60 patients will be included in the study, 30 newly diagnosed ITP patients and 30 newly diagnosed MDS cases.
Criteria

Inclusion Criteria:

  • Patients aged ≥ 18 years old at diagnosis
  • Informed consent in writing
  • Newly diagnosed primary ITP patients, or
  • Newly diagnosed MDS patients

Exclusion Criteria:

  • Patients who participated in a interventional thrombopoietin receptor agonists (TPO-RA) clinical trial since TPO-RA treatment initiation
  • Patients with secondary immune thrombopenia

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 ClinicalTrials.gov identifier (NCT number): NCT03469661


Contacts
Contact: Ana Moreno 0034918166804 ana.moreno@apices.es

Locations
Spain
Complejo Hospitalario de A Coruña Recruiting
A Coruña, Spain
Contact: Maria Fernanda López, MD         
Principal Investigator: Maria Fernanda López, MD         
Hospital de Burgos Recruiting
Burgos, Spain
Contact: Tomas Gonzalez, MD PhD         
Principal Investigator: Tomás Gonzalez, MD PhD         
Hospital Universitario Insular de Gran Canaria Recruiting
Las Palmas De Gran Canaria, Spain
Contact: Fernando Fernández, MD         
Principal Investigator: Fernando Fernández, MD         
Hospital Ramon y Cajal Recruiting
Madrid, Spain
Contact: Ana Jiménez, MD         
Principal Investigator: Ana Jiménez, MD         
Hospital Regional de Málaga Recruiting
Málaga, Spain
Contact: Eva Mingot, MD         
Principal Investigator: Eva Mingot, MD         
Hospital Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Isabel Caparrós, MD         
Principal Investigator: Isabel Caparrós, MD         
Sponsors and Collaborators
Fundacion CRIS de Investigación para Vencer el Cáncer
Amgen
Investigators
Principal Investigator: Tomás González Hospital de Burgos

Responsible Party: Fundacion CRIS de Investigación para Vencer el Cáncer
ClinicalTrials.gov Identifier: NCT03469661     History of Changes
Other Study ID Numbers: FCR-PTI-2017-01
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Blood Platelet Disorders
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Skin Manifestations
Signs and Symptoms