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

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

NCT ID: NCT00265174

Condition: Primary Brain Tumor

Conditions: Official terms:
Brain Neoplasms

Conditions: Keywords:
SERUM DNA
LOH
METHYLATION
GLIOMA
MGMT

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Retrospective

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.

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: LOW AND HIGH GRADE GLIOMAS Exclusion Criteria: NON GLIAL TUMORS

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hdassah Medical Organization

Address:
City: Jerusalem
Zip: 91120
Country: Israel

Contact:
Last name: Arik Tzukert, DMD

Phone: 00-972-2-6777572
Email: lhadas@HADASSAH.ORG.IL

Start date: January 2006

Lead sponsor:
Agency: Hadassah Medical Organization
Agency class: Other

Source: Hadassah Medical Organization

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00265174