Disease: Acute Lymphoblastic LeukemiaALLNCT01785914
Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital.
An observational study of Disease: Acute Lymphoblastic Leukemia, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease: Acute Lymphoblastic Leukemia
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Feb 2014
- 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 patients
Patients with newly diagnosed of acute lymphoblastic leukemia enrolled from 1999 to 2011 at the Division of Hematology, Molinette University Hospital and candidates for therapeutic approach with curative intent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Città della Salute e della Scienza di Torino
Torino, 10126
Benedetto Bruno, MD, +390116336728, benedetto.bruno@unito.it
About this study
This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.
- Conditions
- Disease: Acute Lymphoblastic Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1 year
Event-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease: Acute Lymphoblastic 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benedetto Bruno, Azienda Ospedaliera San Giovanni Battista
- Investigators
- Benedetto Bruno, MD, Principal investigator, Divisione di Ematologia-Città della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785914
- Sponsor's protocol ID
- ALL-TO-2012
- Acronym
- ALL
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital.
- ClinicalTrials.gov ID
- NCT01785914
- Acronym / sponsor ID
- ALL / ALL-TO-2012
- Conditions
- Disease: Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 7 Feb 2013 (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 study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute lymphoblastic leukemia patients
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
Overall survival
Time frame: 1 year
Event-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Benedetto Bruno, MD principal investigator
Divisione di Ematologia-Città della Salute e della Scienza di Torino
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 Disease: Acute Lymphoblastic Leukemia, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Feb 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetto Bruno, MD (+390116336728, benedetto.bruno@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). 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 7 Feb 2013.