Acute Leukemia (Category)PR-GTLANCT02990104
First Report, Five Years Experience of the Acute Leukemia Work Group
An observational study of Acute Leukemia (Category), run by Mexican Agrupation for Hematology Study at 1 site in Mexico.
Trial summary
The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia (Category)
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2016to Jul 2017
- 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: Acute Lymphoblastic Leukemia
Who may be able to join
- Clinical diagnosis of Acute Lymphoblastic Leukemia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Dra. Karla Espinoza, Doctor contact
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico Distrito Federal, 1400
Roberta Demichelis, Doctor, 015554870900 ext. 2700, robertademichelis@gmail.com
Karla Espinoza, Doctor, 015556280400 ext. 60035
About this study
Official title: Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)
The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.
Read the detailed description
Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.
- Conditions
- Acute Leukemia (Category)
What is being measured
The primary outcome is the main question the study is designed to answer.
Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals
Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals
Measured: 5 years
Secondary outcomes (1)
Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals
Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Leukemia (Category)Studies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mexican Agrupation for Hematology Study
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Dr. Erick Crespo, Doctor, Principal investigator, Regional Hospital High Speciality, Tamaulipas Cd. Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990104
- Sponsor's protocol ID
- 2016001/PR-GTLA
- Acronym
- PR-GTLA
- Status last verified
- Nov 2016
- First submitted
- 5 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)
- ClinicalTrials.gov ID
- NCT02990104
- Acronym / sponsor ID
- PR-GTLA / 2016001/PR-GTLA
- Conditions
- Acute Leukemia (Category)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mexican Agrupation for Hematology StudyUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Nov 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 13 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.
The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.
Detailed description
Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Lymphoblastic Leukemia
Key inclusion criteria (1 listed)
- Clinical diagnosis of Acute Lymphoblastic Leukemia
Key exclusion criteria (0 listed)
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
Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals
Time frame: 5 years
Date collection from clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City in 5 reference hospitals
1 secondary outcome
Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Dra. Karla Espinoza, Doctor contact
Dr. Erick Crespo, Doctor principal investigator
Regional Hospital High Speciality, Tamaulipas Cd. Victoria
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 Leukemia (Category), run by Mexican Agrupation for Hematology Study at 1 site in Mexico.
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 0 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 13 Dec 2016. 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 Mexico. 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 Dra. Roberta Demichelis, Doctor (015554870900 ext. 2700, robertademichelis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals (time frame: 5 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 13 Dec 2016.