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Trial Title:
Evaluating the Expression Levels of MicroRNA-10b in Patients With Gliomas
NCT ID:
NCT01849952
Condition:
Astrocytoma
Oligodendroglioma
Oligoastrocytoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Glioblastoma
Brain Tumors
Brain Cancer
Conditions: Official terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Oligodendroglioma
Conditions: Keywords:
glioblastoma
miRNA
GBM
astrocytoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target
genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade
gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA,
miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal
brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b
expression patterns will serve as a prognostic and diagnostic marker. This study will
also characterize the phenotypic and genotypic diversity of glioma subclasses.
Furthermore, considering the critical function of anti-mir-10b in blocking established
glioblastoma growth, the investigators will test in vitro the sensitivity of individual
primary tumors to anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples
will be obtained from patients diagnosed with gliomas over a period of two years. These
samples will be examined for mir-10b expression levels. Patient survival, as well as
tumor grade and genotypic variations will be correlated to mir-10b expression levels.
Criteria for eligibility:
Study pop:
Patients seen in the clinic who are going to be treated with surgery, radiation and
medical therapy for gliomas will be eligible for the study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion/Exclusion Criteria:
- 18 years of age
- Brain tumor(s) to be resected for clinical reasons.
- Histological pathology confirmation that tumor is of glial origin, WHO Grade II, III
or IV.
- Adequate tissue available for processing as determined by Pathology.
- Adequate decision making ability to review, discuss and sign a consent form to allow
their tumor samples to be used for future human brain tumor biology laboratory
research. Determination of capacity to consent is made by one of the
co-investigators based on clinical assessment.
- Patients opting for the standard treatment regimen for their disease as well as
ongoing clinical trials will be are eligible to participate in this study. Standard
care for newly-diagnosed glioblastomas typically consists of surgical resection
followed by radiotherapy with concomitant temozolomide, followed by adjuvant
temozolomide chemotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tufts Medical Center
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Dartmouth-Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Research Nurse
Phone:
800-639-6918
Email:
cancer.research.nurse@dartmouth.edu
Investigator:
Last name:
Arti B Gaur, PhD
Email:
Principal Investigator
Investigator:
Last name:
Linton T Evans, MD
Email:
Principal Investigator
Facility:
Name:
University of Vermont
Address:
City:
Burlington
Zip:
05405
Country:
United States
Status:
Active, not recruiting
Start date:
October 9, 2013
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01849952
https://cancer.dartmouth.edu/patients-families/find-clinical-trial/trial/D12160