NCT00006342

Brief Summary

RATIONALE: Determination of genetic markers for leukemia or non-Hodgkin's lymphoma that is secondary to Hodgkin's disease and childhood brain tumors may help doctors to identify patients who are at risk for these cancers. PURPOSE: Clinical trial to determine the presence of certain genes in patients who are receiving treatment for Hodgkin's disease or childhood brain tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

May 4, 2004

Completed
Last Updated

October 15, 2015

Status Verified

June 1, 2013

Enrollment Period

3.7 years

First QC Date

October 4, 2000

Last Update Submit

October 13, 2015

Conditions

Brain and Central Nervous System TumorsLymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomachildhood infratentorial ependymomachildhood low-grade cerebral astrocytomachildhood supratentorial ependymomastage II childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomachildhood high-grade cerebral astrocytomauntreated childhood brain stem gliomarecurrent childhood brain stem gliomauntreated childhood supratentorial primitive neuroectodermal tumorrecurrent childhood supratentorial primitive neuroectodermal tumoruntreated childhood cerebellar astrocytomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomauntreated childhood medulloblastomarecurrent childhood medulloblastomanewly diagnosed childhood ependymomarecurrent childhood ependymoma

Interventions

chromosomal translocation analysisGENETIC
gene rearrangement analysisGENETIC
mutation analysisGENETIC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of Hodgkin's disease Adult or child OR Diagnosis of primary central nervous system (CNS) malignancy 16 and under Medulloblastoma Ependymoma Brain stem glioma Astrocytoma Primitive neuroectodermal tumor (PNET) Proposed therapy must include external beam radiotherapy and/or chemotherapy PATIENT CHARACTERISTICS: Age: See Disease Characteristics Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaHodgkin DiseaseRecurrenceAstrocytomaMedulloblastomaFamilial ependymoma

Interventions

Gene Rearrangement

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, Primitive

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Edward C. Halperin, MD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

May 4, 2004

Study Start

January 1, 1997

Primary Completion

September 1, 2000

Study Completion

January 1, 2001

Last Updated

October 15, 2015

Record last verified: 2013-06

Locations

US(1)