Glioblastoma Clinical Trial
Official title:
Evaluating the Expression Levels of microRNA-10b in Patients With Gliomas
| NCT number | NCT01849952 |
| Other study ID # | D12160 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 28, 2020 |
| Est. completion date | May 2024 |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | May 2024 |
| Est. primary completion date | May 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | University of Vermont | Burlington | Vermont |
| United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Dartmouth-Hitchcock Medical Center |
United States,
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* Note: There are 21 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | Patients will be followed for survival every 12 weeks +/- 1 week. | 24 months | |
| Secondary | Progression-Free Survival | 24 Months |
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