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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
biologic sample preservation procedure
laboratory biomarker analysis
questionnaire administration
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen's Medical CentreRecruiting

Outcomes

Primary Outcome Measures

Identification of factors that could determine different patterns of tumor development, natural tumor behavior, and tumor sensitivity to therapies

Secondary Outcome Measures

Full Information

First Posted
April 30, 2009
Last Updated
August 23, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00891722
Brief Title
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

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
biologic sample preservation procedure
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Identification of factors that could determine different patterns of tumor development, natural tumor behavior, and tumor sensitivity to therapies

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Walker
Organizational Affiliation
Queen's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-115-924-9924 ext. 61727

12. IPD Sharing Statement

Learn more about this trial

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

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