NCT00265174

Brief Summary

Numerous studies document the ability of tumors to shed DNA into the blood stream. Circulating DNA can thus be recovered for analyses, representing a surrogate tumor material to test for potential applications in disease diagnosis and prognosis. Detection of genetic alternation is one of the most important tests for cancer patient since they offen correlated with the clinical course, prognosis and chemosensitivity of primary brain tumors. Currently in brain tumor patients these molecular aberrations can be analyzed only on tumor tissue that was obtained at surgery or biopsy. Paucity of pathologic samples or poor fixation technique often make the tissue samples unassessable for molecular aberrations. Therefore, the ability to extract tumor DNA from peripheral blood holds a great clinical significance. Still, the molecular aberration evaluated on serum DNA should be correlated and verified by comparison to standard evaluations performed on tumor samples. Our study aim is to evaluate the feasibility of using serum DNA for routine diagnosis of tumor molecular aberrations.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
Last Updated

December 14, 2005

Status Verified

November 1, 2005

First QC Date

December 13, 2005

Last Update Submit

December 13, 2005

Conditions

Primary Brain Tumor

Keywords

SERUM DNALOHMETHYLATIONGLIOMAMGMT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • LOW AND HIGH GRADE GLIOMAS

You may not qualify if:

  • NON GLIAL TUMORS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hdassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Brain NeoplasmsGlioma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • TALI SIEGAL, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • IRIS LAVON, PHD

    Hadassah Medical Organization

    STUDY DIRECTOR

Central Study Contacts

ARIK TZUKERT, DMD

CONTACT

00-972-2-6776095ARIK@HADASSAH.ORG.IL

HADAS LAMBERG, PHD

CONTACT

00-972-2-6777572LHADAS@HADASSAH.ORG.IL

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

January 1, 2006

Last Updated

December 14, 2005

Record last verified: 2005-11

Locations

IL(1)