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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00003291




Registration number
NCT00003291
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
8/08/2014

Titles & IDs
Public title
Molecular Genetic Lesions and Clinical Outcomes in Children With Acute Lymphoblastic Leukemia
Scientific title
Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients
Secondary ID [1] 0 0
COG-B969
Secondary ID [2] 0 0
B969
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - cytogenetic analysis
Other interventions - mutation analysis
Other interventions - laboratory biomarker analysis

Other interventions: cytogenetic analysis


Other interventions: mutation analysis


Other interventions: laboratory biomarker analysis
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Newly diagnosed acute lymphoblastic leukemia (ALL)

- Meets criteria for 1 of the following:

- Standard risk, as defined by the following:

- 1 to 10 years old at diagnosis

- WBC less than 50,000/mm^3

- High risk, as defined by the following:

- Less than 1 year old or over 10 years old at diagnosis

- WBC greater than 50,000/mm^3

- Enrolled on CCG-1922 (standard-risk ALL) or CCG-1882 or CCG-1901 (high-risk ALL)

PATIENT CHARACTERISTICS:

Age:

- See Disease Characteristics

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified
Minimum age
No limit
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: The identification of gene mutations may allow doctors to better determine the
prognosis of children with acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying gene mutations to see if they are related to
prognosis of cancer in children with acute lymphoblastic leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ursula R. Kees, PhD
Address 0 0
Telethon Institute for Child Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00003291