Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02375334
Status:
TERMINATED
Last Update Posted:
2018-07-03
First Post:
2015-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence Monitoring System in Managing Myelosuppression in Patients With Newly Diagnosed Malignant Gliomas Receiving Temozolomide and Radiation Therapy
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Comparative Development of Data Driven Systems for Insuring Timely Monitoring for Brain Tumor Patients for Management of Myelosuppression
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Support Staff Left Institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research trial studies an adherence monitoring system in managing myelosuppression in patients with newly diagnosed malignant gliomas who are receiving temozolomide and radiation therapy. The development of an adherence monitoring system may help doctors more effectively utilize electronic medical records to manage myelosuppression during standard treatment with temozolomide and radiation therapy in patients with malignant gliomas.
Detailed Description:
PRIMARY OBJECTIVES:
I. To develop an adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center Oncology Research Information System (ORIS) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
II. To test the newly designed Epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by ORIS for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
SECONDARY OBJECTIVES:
I. To develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring.
OUTLINE:
Patient lab and visit dates are monitored by the Cancer Center ORIS and EPIC based systems during the 42 days of the concurrent temozolomide and radiation therapy.
I. To develop an adherence monitoring system within Epic that is functionally equivalent to the previously designed and validated system in the Cancer Center Oncology Research Information System (ORIS) for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
II. To test the newly designed Epic system by comparing the frequency and timing of flags (laboratory date flags, visit date flags and in-patient status flags) and non-adherent days generated with the frequency and timing of those generated by ORIS for patients with newly diagnosed malignant gliomas receiving concurrent temozolomide and radiation therapy.
SECONDARY OBJECTIVES:
I. To develop both systems so that they may be easily adapted in the future to other therapies that require compliance monitoring.
OUTLINE:
Patient lab and visit dates are monitored by the Cancer Center ORIS and EPIC based systems during the 42 days of the concurrent temozolomide and radiation therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00113 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CCCWFU 99115 | None | None | View | |
| CCCWFU # 99115 | OTHER | Comprehensive Cancer Center of Wake Forest University | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |