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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01785914
Other study ID # ALL-TO-2012
Secondary ID
Status Recruiting
Phase N/A
First received February 5, 2013
Last updated February 5, 2013
Start date February 2013
Est. completion date February 2014

Study information

Verified date February 2013
Source Azienda Ospedaliera San Giovanni Battista
Contact Benedetto Bruno, MD
Phone +390116336728
Email benedetto.bruno@unito.it
Is FDA regulated No
Health authority Italy: Ministery of Health
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Città della Salute e della Scienza di Torino Torino

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 1 year Yes
Primary Event-free survival 1 year Yes