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

Primary Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00265174
• Other study ID #: IRISL1-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2005
• Last updated: December 13, 2005
• Start date: January 2006

Study information

• Verified date: November 2005
• Source: Hadassah Medical Organization
• Contact: ARIK TZUKERT, DMD
• Phone: 00-972-2-6776095
• Email: ARIK[@]HADASSAH.ORG.IL
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

LOW AND HIGH GRADE GLIOMAS

Exclusion Criteria:

NON GLIAL TUMORS

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Primary Brain Tumor

Locations

Country	Name	City	State
Israel	Hdassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,