Contents
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Record details of prior surgery related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study.
Field Name | Description / Instructions | Format |
|---|---|---|
Date of Surgery(m) | Enter the date of the surgical procedure. Partial dates are acceptable when the day is not known. | DD-MMM-YYYY or MMM-YYYY |
| Surgery Relapse Date | Enter the calendar date of return of disease following surgery with a period of improvement or complete remission. | DD-MMM-YYYY |
| Surgery Reason | Select text term to explain the surgical setting or reason surgery was used for a patient. | Use pick list. |
Procedure | Select the name of a surgical procedure used to resection or remove a portion of a brain lesion. | Use pick list. |
| Extent of tumor resection | Select the extent to which an abnormal mass of tissue that results from excessive cell division was surgically removed. | Use pick list. |
| Other Specify | The free-text field used to describe the name assigned to a surgical procedure done for diagnostic, surveillance, treatment, palliation, or study-directed purposes. | 200 characters |
| Surgery Organ | Select the named location with the central nervous system that was the site of a surgical procedure. | Use pick list. |
Surgery Site | Select the named and more specified location in the body that was the site of a surgical procedure. | Use pick list. |
| Surgery Location | Select the named location in the body for a surgical procedure. | Use pick list. |
| Site Location | Select the text term to identify the specified/detailed anatomic location of a malignant neoplasm that arises from or metastasize to structures within the cranium. | Use pick list. |
| Side Detail | Select specification relating to the side or laterality of an anatomic location. | Use pick list. |
Post-op Histologic Diagnosis | Select the brain tumor histologic term. | Use pick list. |
Histology Grade | Enter the histologic grade | 10 characters |
| CSF Cytology Results | Select the summary result of a cerebrospinal fluid (CSF) cytological laboratory finding. | Use pick list. |
| Did the patient re-initiate protocol Tx post-operatively? | Select from the yes/no indicator related to a patient initiating the administration of therapy. | Use pick list. |
Post-op Chemotherapy Start Date | Enter the calendar date on which a chemotherapy agent or regimen was started on a postoperative patient. | DD-MMM-YYYY |
| Post-op Radiographic Assessment Date | Enter the calendar date on which a radiographic assessment was done on a postoperative patient. | DD-MMM-YYYY |
Legend: (m) RDC mandatory |
Code | Description | Resolutions |
|---|---|---|
PSG01 | Date of Surgery is in the future. | Enter a date that is equal to or earlier than the current date. |