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Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Completed
CT.gov ID
NCT02986620
Collaborator
(none)
388
Enrollment
24
Locations
40.7
Actual Duration (Months)
16.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.

This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Condition or Disease Intervention/Treatment Phase
  • Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Detailed Description

The study will be conducted as follows:

  1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).

  2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
388 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Actual Study Start Date :
Oct 31, 2017
Actual Primary Completion Date :
Mar 22, 2021
Actual Study Completion Date :
Mar 22, 2021

Arms and Interventions

Arm Intervention/Treatment
AML patients

Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
Observation of the test result.

Outcome Measures

Primary Outcome Measures

  1. Number of patients with the IDH mutations in AML at initial diagnosis. [At two years from study entry.]

  2. Number of patients with the IDH mutations in AML at relapse. [At three years from study entry.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);

  • AML patients;

  • Age ≥18;

  • IDH mutation test performed at diagnosis or relapse until January 31st, 2019.

Exclusion criteria:
  • AML M3 subtype according to the FAB classification;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia Alessandria Italy
2 Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Bari Italy
3 Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia Bologna Italy
4 Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Bologna Italy
5 Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia Brindisi Italy
6 I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica Meldola Italy
7 AOU Policlinico G. Martino Messina Italy
8 Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia Milano Italy
9 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano Milano Italy
10 Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia Milano Italy
11 Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia Milano Italy
12 UO Ematologia _AOU Policlinico di Modena Modena Italy
13 Università degli Studi di Padova - Ematologia ed Immunologia Clinica Padova Italy
14 Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Palermo Italy
15 AU Policlinico "Paiolo Giaccone" Palermo Italy
16 Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo Parma Italy
17 Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia Perugia Italy
18 Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti Piacenza Italy
19 IFO Istituto Nazionale Tumori Regina Elena Roma Italy
20 Università Cattolica del Sacro Cuore - Policlinico A.Gemelli Roma Italy
21 Università degli Studi - Policlinico di Tor Vergata Roma Italy
22 Università degli Studi - Policlinico Tor Vergata Rome Italy
23 Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia San Giovanni Rotondo Italy
24 Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica Udine Italy

Sponsors and Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Study Chair: Giovanni Martinelli, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
  • Study Director: Maria Teresa Voso, U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT02986620
Other Study ID Numbers:
  • AML1516
First Posted:
Dec 8, 2016
Last Update Posted:
Jan 4, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jan 4, 2022