Clinical trial NCT00891722: Tumor Tissue, Blood Samples, and Family History in Predicting Tumor Development and Response to Treatment in Young Patients With Low-Grade Glioma
Official title: Translation Study for Children and Adolescents With Low Grade Glioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain and Central Nervous System Tumors
Keywords: recurrent childhood brain stem glioma
untreated childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
untreated childhood cerebellar astrocytoma
childhood low-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
childhood oligodendroglioma
recurrent childhood visual pathway and hypothalamic glioma
untreated childhood visual pathway and hypothalamic glioma
childhood mixed glioma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-01
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identification of factors that could determine different patterns of tumor development, natural tumor behavior, and tumor sensitivity to therapies
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
state: England
Study officials:
affiliation: Queen's Medical Center
name: David A. Walker
role: PRINCIPAL_INVESTIGATOR
References: