NCT03279900

Brief Summary

This study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

August 28, 2017

Last Update Submit

September 17, 2018

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.

    based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy.

    october 2017

Secondary Outcomes (1)

  • The relationship of the incidence of hematotoxicity with influencing factors

    November 2017

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014

You may qualify if:

  • LLA Patients, male and female, age 1 - \<18 years
  • Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013

You may not qualify if:

  • Incomplete medical record data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusomo hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

  • Rianto Setiabudy, Professor

    Departemen of Pharmacology and therapeutics, FMUI

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 12, 2017

Study Start

October 2, 2017

Primary Completion

May 16, 2018

Study Completion

July 16, 2018

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)