AMLNCT02607059
Epidemiologic Registry PETHEMA LMA 2015
An observational study of AML, run by PETHEMA Foundation at 1 site in Spain.
Trial summary
Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- Registry
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- May 2015to Dec 2021
- How long will I take part?
- 3 Years
- 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: Patients diagnosed with acute myeloid leukemia
Who may be able to join
- Patients diagnosed with acute myeloid leukemia
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Pau Montesinos, Dr contact
Spain1 site, 1 recruiting
- Recruiting
Hospital La Fe
Valencia
Pau Montesinos, Dr, montesinos_pau@gva.es
About this study
Official title: Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2015)
Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach
Read the detailed description
To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases
- Conditions
- AML
- Being tested
- Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics of the patients diagnosed of AML
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AMLStudies 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607059
- Sponsor's protocol ID
- LAM 2015
- Status last verified
- Mar 2021
- First submitted
- 13 Oct 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Labrador J, Martinez-Cuadron D, Boluda B, Serrano J, Gil C, Perez-Simon JA, Bernal T, Bergua JM, Martinez-Lopez J, Rodriguez-Medina C, Vidriales MB, Garcia-Boyero R, Algarra L, Polo M, Sayas MJ, Tormo M, Alonso-Dominguez JM, Herrera P, Lavilla E, Ramos F, Amigo ML, Vives-Polo S, Rodriguez-Macias G, Mena-Duran A, Perez-Encinas MM, Arce-Fernandez O, Cuello R, Sanchez-Garcia J, Gomez-Casares MT, Chillon MC, Calasanz MJ, Ayala R, Rodriguez-Veiga R, Barragan E, Montesinos P; PETHEMA Group. Evolving patterns and clinical outcome of genetic studies performed at diagnosis in acute myeloid leukemia patients: Real life data from the PETHEMA Registry. Cancer. 2024 Oct 15;130(20):3436-3451. doi: 10.1002/cncr.35431. Epub 2024 Jun 19.
PubMed 38896056Martinez-Cuadron D, Megias-Vericat JE, Serrano J, Martinez-Sanchez P, Rodriguez-Arboli E, Gil C, Aguiar E, Bergua J, Lopez-Lorenzo JL, Bernal T, Espadana A, Colorado M, Rodriguez-Medina C, Lopez-Pavia M, Tormo M, Algarra L, Amigo ML, Sayas MJ, Labrador J, Rodriguez-Gutierrez JI, Benavente C, Costilla-Barriga L, Garcia-Boyero R, Lavilla-Rubira E, Vives S, Herrera P, Garcia-Belmonte D, Herraez MM, Vasconcelos Esteves G, Gomez-Roncero MI, Cabello A, Bautista G, Balerdi A, Mariz J, Boluda B, Sanz MA, Montesinos P. Treatment patterns and outcomes of 2310 patients with secondary acute myeloid leukemia: a PETHEMA registry study. Blood Adv. 2022 Feb 22;6(4):1278-1295. doi: 10.1182/bloodadvances.2021005335.
PubMed 34794172
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2015)
- ClinicalTrials.gov ID
- NCT02607059
- Acronym / sponsor ID
- LAM 2015
- Conditions
- AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Nov 2015 (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.
Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary acute myeloid leukemia (AML) in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach
Detailed description
To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute myeloid leukemia
Key inclusion criteria (1 listed)
- Patients diagnosed with acute myeloid leukemia
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Registry | Other | – |
Primary outcome
characteristics of the patients diagnosed of AML
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 38896056Labrador J, Martinez-Cuadron D, Boluda B, Serrano J, Gil C, Perez-Simon JA, Bernal T, Bergua JM, Martinez-Lopez J, Rodriguez-Medina C, Vidriales MB, Garcia-Boyero R, Algarra L, Polo M, Sayas MJ, Tormo M, Alonso-Dominguez JM, Herrera P, Lavilla E, Ramos F, Amigo ML, Vives-Polo S, Rodriguez-Macias G, Mena-Duran A, Perez-Encinas MM, Arce-Fernandez O, Cuello R, Sanchez-Garcia J, Gomez-Casares MT, Chillon MC, Calasanz MJ, Ayala R, Rodriguez-Veiga R, Barragan E, Montesinos P; PETHEMA Group. Evolving patterns and clinical outcome of genetic studies performed at diagnosis in acute myeloid leukemia patients: Real life data from the PETHEMA Registry. Cancer. 2024 Oct 15;130(20):3436-3451. doi: 10.1002/cncr.35431. Epub 2024 Jun 19.
- Derived from this study: PubMed 34794172Martinez-Cuadron D, Megias-Vericat JE, Serrano J, Martinez-Sanchez P, Rodriguez-Arboli E, Gil C, Aguiar E, Bergua J, Lopez-Lorenzo JL, Bernal T, Espadana A, Colorado M, Rodriguez-Medina C, Lopez-Pavia M, Tormo M, Algarra L, Amigo ML, Sayas MJ, Labrador J, Rodriguez-Gutierrez JI, Benavente C, Costilla-Barriga L, Garcia-Boyero R, Lavilla-Rubira E, Vives S, Herrera P, Garcia-Belmonte D, Herraez MM, Vasconcelos Esteves G, Gomez-Roncero MI, Cabello A, Bautista G, Balerdi A, Mariz J, Boluda B, Sanz MA, Montesinos P. Treatment patterns and outcomes of 2310 patients with secondary acute myeloid leukemia: a PETHEMA registry study. Blood Adv. 2022 Feb 22;6(4):1278-1295. doi: 10.1182/bloodadvances.2021005335.
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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.
Pau Montesinos, Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML, run by PETHEMA Foundation at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pau Montesinos, Dr (montesinos_pau@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristics of the patients diagnosed of AML (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02607059, which also lists 2 linked publications.
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 23 Mar 2021.