Tumor Tissue, Blood Samples, and Family History in Predicting Tumor Development and Response to Treatment in Young Patients With Low-Grade Glioma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00891722

First received: April 30, 2009

Last updated: July 1, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

July 1, 2009

Start Date ^ICMJE

August 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Identification of factors that could determine different patterns of tumor development, natural tumor behavior, and tumor sensitivity to therapies [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00891722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tumor Tissue, Blood Samples, and Family History in Predicting Tumor Development and Response to Treatment in Young Patients With Low-Grade Glioma

Official Title ^ICMJE

Translation Study for Children and Adolescents With Low Grade Glioma

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand why low-grade gliomas develop in young patients and predict how they will respond to treatment.

PURPOSE: This clinical trial is studying tumor tissue, blood samples, and family history in predicting tumor development and response to treatment in young patients with low-grade glioma.

Detailed Description

OBJECTIVES:

To develop a better understanding of why low-grade glioma tumors develop in children and adolescents.
To study genetic profiles that may predict response to treatment and provide clues to how these tumors developed initially using tumor and blood samples from these patients.

OUTLINE: This is a multicenter study.

Retrospective data collection (for participants recruited from study SIOP-LGG1): During a follow-up appointment for study SIOP-LGG1, both biological parents* are asked to complete a questionnaire about their family's cancer history. They may complete the questionnaire either in the clinic or in their home. Participants may complete and return the questionnaires at any time throughout the study.
Prospective data collection (for participants recruited from study SIOP-LGG-2004): Both biological parents* are asked to complete a family history questionnaire and provide information about their family's cancer history. Participants may complete and return the questionnaires at any time throughout the study.

NOTE: *In circumstances where either or both biological parents are unable to complete the questionnaire, it may be completed by the patient diagnosed with low grade glioma (if they are over 16 years old) or adoptive parents or guardians, if they feel they have the knowledge to complete the questionnaire.

Tumor tissue and blood samples collected on SIOP-LGG1 or SIOP-LGG-2004 are analyzed for genetic profiles predictive of response to treatment and for different patterns of tumor development, natural tumor behavior, and tumor sensitivity to cancer therapies. Collected family data are anonymised and linked to the biological sample collected. Samples are then stored for future molecular genetic studies.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Brain and Central Nervous System Tumors

Intervention ^ICMJE

Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

900

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Biological parents of a child or adolescent patient diagnosed with low grade glioma (LGG)
- LGG patients participating in 1 of the following clinical trials:
  - On active follow up for study SIOP-LGG1 at a Children's Cancer and Leukemia Group center
  - On study SIOP-LGG-2004
- Adoptive parents or guardians allowed if they feel they have the knowledge to complete the study questionnaire, provided either or both biological parents are unable to complete the questionnaire

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00891722

Other Study ID Numbers ^ICMJE

CDR0000614912, CCLG-CNS-2007-13-TRANSCAL, EU-20879

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Children's Cancer and Leukaemia Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David A. Walker

Queen's Medical Centre

Information Provided By

National Cancer Institute (NCI)

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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