Evaluating familial cases of blood cancers in patients with myeloid neoplasms
A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS)
This study looks at families with a history of blood cancers to see how often people with Acute Myeloid Leukemia or Myelodysplastic Syndromes also have relatives affected by these diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 237 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 27 sites (Alessandria and 26 other locations) |
| Trial ID | NCT04460950 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the incidence of familial Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) in patients diagnosed with these conditions between January 2014 and December 2022. It will collect clinical information from multiple centers, focusing on patients who have at least one relative affected by hematologic neoplasms or other cancers diagnosed at a young age. The study will follow participants until December 2023 to gather comprehensive data on familial patterns of these diseases. No interventions will be administered, as the study is purely observational.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with AML or MDS who have a family history of hematologic malignancies or solid tumors diagnosed before age 40.
Not a fit: Patients without a family history of myeloid neoplasms or related cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the genetic factors contributing to familial AML and MDS, potentially leading to improved screening and prevention strategies.
How similar studies have performed: While this approach is observational, similar studies have successfully identified familial patterns in other cancers, suggesting potential for valuable insights in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient age \> 18 years old * Diagnosis of AML or MDSs from January 2014 to December 2022 * Suspected familiarity for myeloid neoplasm: at least one family member of first or second degree affected by myeloid neoplasm or other hematological malignancy, or by solid tumors with onset at age \< 40 years or presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs * Signed written informed consent according to ICH/EU/GCP and national local laws. Exclusion Criteria: * none
Where this trial is running
Alessandria and 26 other locations
- Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia — Alessandria, Italy (Recruiting)
- Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica — Ancona, Italy (Recruiting)
- Ao Di Rilievo Nazionale E Di Alta Specialità "San Giuseppe Moscati" - Avellino - Uoc Ematologia Con Unità Di Trapianto — Avellino, Italy (Recruiting)
- Asl Caserta, Presidio Ospedaliero S.G.Moscati - Aversa - Uo Oncoematologia — Aversa, Italy (Recruiting)
- Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia — Bologna, Italy (Recruiting)
- Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia — Brescia, Italy (Recruiting)
- Asst Degli Spedali Civili Di Brescia - Uo Ematologia — Brescia, Italy (Recruiting)
- Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo — Cagliari, Italy (Recruiting)
- Aou Ospedali Riuniti - Foggia - Uoc Ematologia — Foggia, Italy (Recruiting)
- Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia — Lecce, Italy (Recruiting)
- Ao Ospedali Riuniti "Papardo Piemonte" - Po Papardo - Messina - Sc Ematologia — Messina, Italy (Recruiting)
- Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia — Milano, Italy (Recruiting)
- Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora — Milano, Italy (Recruiting)
- Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia — Orbassano, Italy (Recruiting)
- Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia — Pagani, Italy (Recruiting)
- Aou Policlinico P. Giaccone - Palermo - Uo Ematologia — Palermo, Italy (Recruiting)
- Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo — Parma, Italy (Recruiting)
- Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo — Perugia, Italy (Recruiting)
- Aou Pisana - Uo Ematologia Universitaria — Pisa, Italy (Recruiting)
- Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia — Reggio Emilia, Italy (Recruiting)
- Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia — Rimini, Italy (Recruiting)
- Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia — Roma, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica — Roma, Italy (Recruiting)
- Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia — San Giovanni Rotondo, Italy (Recruiting)
- Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia — Sassari, Italy (Recruiting)
- Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino — Torino, Italy (Recruiting)
- Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica — Udine, Italy (Recruiting)
Study contacts
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.