AML, AdultNCT02986620
Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
An observational study of AML, Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 24 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
- How many people
- 388 participants
- Where
- 24 sitesItaly
- Study dates
- 31 Oct 2017to 22 Mar 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult AML patients
Who may be able to join
- 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.
Who cannot join
- AML M3 subtype according to the FAB classification;
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna
Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia
Brindisi
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
Meldola
AOU Policlinico G. Martino
Messina
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
Milan
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
Milan
UO Ematologia _AOU Policlinico di Modena
Modena
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo
AU Policlinico "Paiolo Giaccone"
Palermo
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo
Parma
Sezione di ematologia ed immunologia - Clinica Ospedale S. Maria della Misericordia
Perugia
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza
IFO Istituto Nazionale Tumori Regina Elena
Roma
Università Cattolica del Sacro Cuore - Policlinico A.Gemelli
Roma
Università degli Studi - Policlinico di Tor Vergata
Roma
Università degli Studi - Policlinico Tor Vergata
Rome
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine
About this study
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.
Read the detailed description
The study will be conducted as follows:
- 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).
- 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.
- Conditions
- AML, Adult
- Being tested
- IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDH mutation test performed at diagnosis or relapse until January 31st, 2019.Genetic
Observation of the test result.
| Study group | Role | What they receive |
|---|---|---|
| AML patients | Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019. Receives: Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with the IDH mutations in AML at initial diagnosis.
Measured: At two years from study entry.
Number of patients with the IDH mutations in AML at relapse.
Measured: At three years from study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start31 Oct 2017
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 388 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Martinelli, Study chair, Department of Experimental, Diagnostic and Specialty Medicine, University of BolognaMaria Teresa Voso, Study director, U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986620
- Sponsor's protocol ID
- AML1516
- Status last verified
- Sep 2021
- First submitted
- 6 Dec 2016
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02986620
- Acronym / sponsor ID
- AML1516
- Conditions
- AML, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted as follows:
- 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).
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients | – | Genetic: IDH mutation test performed at diagnosis or relapse until January 31st, 2019.Adult AML patients with the IDH mutation test performed at diagnosis or relapse until January 31st, 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult AML patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- AML M3 subtype according to the FAB classification;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDH mutation test performed at diagnosis or relapse until January 31st, 2019.Observation of the test result. | Genetic | AML patients |
Primary outcome
Number of patients with the IDH mutations in AML at initial diagnosis.
Time frame: At two years from study entry.
Number of patients with the IDH mutations in AML at relapse.
Time frame: At three years from study entry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli study chair
Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna
Maria Teresa Voso study director
U.O.C. Ematologia Dipartimento di Medicina, Policlinico Tor Vergata of Rome
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with the IDH mutations in AML at initial diagnosis. (time frame: At two years from study entry.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.