Serum DNA Analysis: Potential Application for Diagnosis and Prognosis in Brain Cancer.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00265174
First received: December 13, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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.


Condition
Primary Brain Tumor

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Serum DNA Analysis: Potential Application for Diagnosis and Prognosis in Brain Cancer.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 60
Study Start Date: January 2006
Detailed Description:

Backround:

Genetic and epigenetic abrasions like loss of hetherozygosity and hypermethylation of gene promoters are common aberration in gliomas. Detection of these aberrations serves as diagnostic and prognostic tool. Examples: 1. oligodendrogliomas patients with combined 1p/19q LOH within the tumor respond better to chemotherapy and have better prognosis, whereas LOH on chromosome 10q is a marker for worse prognosis. 2. GBM patients with hypermethylation of the promoter of methyl-guanine-methyl-transferase (MGMT) in the tumor respond better to alkylating agent and have better prognosis.

As sample materials for diagnosis should be easily accessible by a minimally invasive procedure, there has been much interest in the potential use of nucleic acid markers in the blood of patients with cancer.

It was demonstrated that LOH as well as hypermethylation could be detected in the plasma/serum of patients with a variety of malignancies, suggesting that circulating tumor-associated DNA in the blood of patients can be a key determinant in predicting genetic and epigenetic abrasions in the tumor.

Objectives of the study:

Main objective: to find whether genetic abrasions in serum DNA represent the tumor DNA in patients with brain tumor.

Is tumor DNA can be detected in the serum of only high grade tumors or also in low grade tumor?

Methods:

Blood serum and tumor of patients are obtained anonymously, after the patient has signed a consent form, prior to surgery as part of the procedure for tissue collection for the brain tumor bank at Hadassah.

Part of the tumor is stained with hematoxylin-and-eosin and Histopathologic diagnosis is performed by a pathologist.

DNA is extracted from whole blood, serum and tumor of all patients with low grade or high grade gliomas.

In order to determine whether serum DNA represents the tumor DNA, LOH of 1p,19q,10q,17p,13q, 9p as well as methylation status of MGMT promoter will be tested in DNA samples from blood, serum and tumor.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

LOW AND HIGH GRADE GLIOMAS

Exclusion Criteria:

NON GLIAL TUMORS

  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: NCT00265174

Contacts
Contact: ARIK TZUKERT, DMD 00-972-2-6776095 ARIK@HADASSAH.ORG.IL
Contact: HADAS LAMBERG, PHD 00-972-2-6777572 LHADAS@HADASSAH.ORG.IL

Locations
Israel
Hdassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00-972-2-6777572    lhadas@HADASSAH.ORG.IL   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: TALI SIEGAL, MD Hadassah Medical Organization
Study Director: IRIS LAVON, PHD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265174     History of Changes
Other Study ID Numbers: IRISL1-HMO-CTIL
Study First Received: December 13, 2005
Last Updated: December 13, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
SERUM DNA
LOH
METHYLATION
GLIOMA
MGMT

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

ClinicalTrials.gov processed this record on August 28, 2014