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Clinical Trials in Italy / NCT03058588
Recruiting Observational

Next Generation Sequencing (NGS) in Familial Acute Myeloid Leukemia and Myelodisplastic Syndromes

NCT03058588 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Phase
Observational
Started
2017-02-09
Last updated
2026-04-30

Condition(s) studied

Leukemia

Investigational drug(s) / intervention(s)

Analysis with molecular biology

Analysis with molecular biology: Molecular screening by next generation sequencing (NGS) platform, for known and unknown mutations potentially associated with the disease

Study summary

The aim of this study is to look for predisposing mutations in patients and relatives affected by AML and MDS with familial history of myeloid or, less frequently, lymphoid malignancies. Taking advantage of a next generation sequencing (NGS) platform, screening for known and unknown mutations potentially associated with the disease will be done. The screening will be performed on affected and unaffected family members, in order to outline new pedigrees that either validate previous findings or constitute novel discoveries.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion criteria: Any patient with acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS) with: 1. a first- or second-degree relative with Acute leukemia or MDS or other myeloid malignancies 2. a first- or second-degree relative with Lymphoproliferative neoplasms 3. or with clinical features that resemble one of the familial MDS/AML predisposition syndromes: * History of thrombocytopenia and/or a clinical bleeding propensity (as in RUNX1, ANKRD26 or ETV6 germline mutations) * Abnormal nails or skin pigmentation, oral leukoplakia, idiopathic pulmonary fibrosis, unexplained liver disease (as in TERT and TERC germline mutations) * Lymphedema, atypical infections, immune deficiencies (as in GATA2 germline mutations) Exclusion Criteria: 1. any diagnosis other than acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS); 2. acute myeloid leukemia (AML) or Myelodisplastic Syndrome (MDS) without a first- or second-degree relative with Acute leukemia or MDS or other myeloid malignancies or without a first- or second-degree relative with Lymphoproliferative neoplasms or with clinical features that resemble one of the familial MDS/AML predisposition syndromes; 3. unability to sign the informed consent

Primary outcome measure(s)

  • Discovery of predisposing mutations — After enrollment of the first 10 cases (an avarage of 2 years)
    Screening of tumor and germline DNA for predisposing mutations

Trial sites (1)

FacilityCityRegionStatus
Chair of Hematology and Bone marrow Transplant Unit Brescia Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03058588 on ClinicalTrials.gov ↗ ← All trials in Italy