Acute Myeloid LeukemiaNCT03433521
Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 15,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 15 Jan 2019
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Spanish population
Inclusion Criteria Patients with a first diagnostic of AML between 2004 and 2014.
.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Investigacion Sanitaria Fundacion Jimenez Diaz
Madrid, 28040
About this study
Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Spatio-Temporal Diagnostic Pattern
- Medical subject headings
- Leukemia, Myeloid, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
AML diagnosis
Diagnosis of de-novo AML
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jan 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433521
- Sponsor's protocol ID
- EO 100/2017_FJD-HRJC
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Spatio-Temporal Patterns of New Cases of Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03433521
- Acronym / sponsor ID
- EO 100/2017_FJD-HRJC
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Spatio-Temporal Diagnostic Pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 14 Feb 2018 (actual)
- 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.
Published data regarding the temporal pattern of AML are scarce and old. The greater knowledge of these neoplasias has made that their classification has been remarkable modified. Therefore, we consider relevant to carry out the present study as it would allow us to analyze the potential existence of a spatio-temporal pattern in the incidence of AML in Spain.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Spanish population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AML diagnosis
Time frame: 10 years
Diagnosis of de-novo AML
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 28 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Myeloid Leukemia, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. 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?
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?
AML diagnosis (time frame: 10 years). 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 28 Feb 2019.