Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265174
Status:
UNKNOWN
Last Update Posted:
2005-12-14
First Post:
2005-12-13
Brief Title:
Serum DNA Analysis Potential Application for Diagnosis and Prognosis in Brain Cancer
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Serum DNA Analysis Potential Application for Diagnosis and Prognosis in Brain Cancer
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1p19q 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 plasmaserum 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 1p19q10q17p13q 9p as well as methylation status of MGMT promoter will be tested in DNA samples from blood serum and tumor
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 1p19q 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 plasmaserum 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 1p19q10q17p13q 9p as well as methylation status of MGMT promoter will be tested in DNA samples from blood serum and tumor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None