Adult Glioma Clinical Trial
Official title:
Registry Describing Clinical Information, Conventional, and Advanced Magnetic Resonance Imaging Information of Patients With Brain Glioma
This registry aims to collect clinical and radiologic information including detailed clinical, conventional MR and advanced MR imaging data of patients with brain gliomas. Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and chemical exchange saturation transfer (CEST) imaging. This registry will describe course of disease and long-term outcomes of brain gliomas.
| Status | Recruiting |
| Enrollment | 9000 |
| Est. completion date | December 2040 |
| Est. primary completion date | December 2040 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients must have radiologically and histologically confirmed diagnosis of Brain Glioma - Life expectancy of greater than 3 months - Must receive a first- or second-line therapy - Signed informed consent Exclusion Criteria: - No brain gliomas - Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction - Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Asan Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Asan Medical Center |
Korea, Republic of,
Marko NF, Weil RJ, Schroeder JL, Lang FF, Suki D, Sawaya RE. Extent of resection of glioblastoma revisited: personalized survival modeling facilitates more accurate survival prediction and supports a maximum-safe-resection approach to surgery. J Clin Oncol. 2014 Mar 10;32(8):774-82. doi: 10.1200/JCO.2013.51.8886. Epub 2014 Feb 10. — View Citation
Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16. Erratum In: Semin Oncol. 2015 Jun;42(3):e33-43. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Documentation of clinical information (demographics and Karnofsky performance score) | 5 years per patient | ||
| Primary | Documentation of treatment | 5 years per patient | ||
| Primary | Documentation of radiologic information of conventional MR imaging and advanced MR imaging | 5 years per patient | ||
| Secondary | Progression Free Survival (PFS) | Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression. | On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months) | |
| Secondary | One- year survival | Number of months from date of diagnosis to date of death | One year | |
| Secondary | Overall Survival | 5 years | ||
| Secondary | Identification of Imaging biomarkers of clinical significance (prognostic) | 5 years |