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: August 23, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention
Brain and Central Nervous System Tumors
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Official Title: Translation Study for Children and Adolescents With Low Grade Glioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 900
Study Start Date: August 2008
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891722

Locations
United Kingdom
Queen's Medical Centre Recruiting
Nottingham, England, United Kingdom, NG7 2UH
Contact: Contact Person    44-115-924-9924 ext. 61727      
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
Principal Investigator: David A. Walker Queen's Medical Centre
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00891722     History of Changes
Other Study ID Numbers: CDR0000614912, CCLG-CNS-2007-13-TRANSCAL, EU-20879
Study First Received: April 30, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014