Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549246
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2020-08-13
Brief Title:
Grid Therapy for Tumors of the Head Neck Thorax Abdomen Pelvis and Extremities
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Spatially Fractionated Radiation Grid Therapy for Tumors of the Head Neck Thorax Abdomen Pelvis and Extremities
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
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:
This study is an observational registry study evaluating the clinical outcomes of grid therapy Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study Once consent has been obtained baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks for toxicity and 3-6 months for toxicities and radiographic control then per clinical discretion up to 1 year Patients will be evaluated according to the physicians standard practice and discretion Patient data will be drawn from the patients medical records and reported by means of a web-based electronic data collection EDC system Patients will be considered on study until 60 months of observation has occurred withdrawal of consent lost to follow-up or study closure See below for the clinical visit flowchart for data collected at baseline and standard clinic visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-012801 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2022-105 | REGISTRY | None | None |
| ROR1903 | OTHER | None | None |