Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04122430 |
| Other study ID # |
QA2015168 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2015 |
| Est. completion date |
October 16, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Walter and Eliza Hall Institute of Medical Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Recent data (Srikanthan and Tran et al. JCO 2014, in press) have demonstrated that the
presence of large retroperitoneal lymph node metastases on baseline staging scans (measuring
>5cm in axial dimension) are associated with significantly increased risk of venous
thromboembolism in patients receiving first line chemotherapy for disseminated germ cell
tumours.
This study, a G3 collaborative effort, aims to confirm these findings in a large
multi-national validation cohort.
Description:
Recent data (Srikanthan and Tran et al. JCO 2014, in press) have demonstrated that the
presence of large retroperitoneal lymph node (RPLN) metastases on baseline staging scans
(measuring >5cm in axial dimension) are associated with significantly increased risk of
venous thromboembolism (VTE) in patients receiving first line chemotherapy for disseminated
germ cell tumours (GCT).
This study, a G3 collaborative effort, aims to confirm these findings in a large
multi-national validation cohort.
Primary objective:
To validate the association between large RPLN metastases (measuring >5cm in axial dimension)
and increased risk of VTE during and immediately after completion of (within 90 days) first
line chemotherapy for disseminated GCT.
Secondary objectives:
- To assess the discriminatory accuracy for VTE of both large RPLN metastases and
high-risk Khorana score (defined as > 3)
- To determine the incidence of VTE in patients with disseminated GCT receiving first line
chemotherapy at baseline, during chemotherapy and immediately following chemotherapy
- To determine the incidence of VTE during and immediately after chemotherapy in patients
receiving prophylactic anticoagulation during first line chemotherapy for disseminated
GCT
- To determine the incidence of major bleeding in patients who received prophylactic
anticoagulation versus those who did not
- To determine overall survival at 12 months, 3 years and 5 years for patients who
developed VTE compared to those who did not No identifying data (e.g. name, hospital UR,
address) will be collected.
Data will be collected by retrospective review of the medical chart.
When assessing for the presence of large RPLN as a risk factor for VTE, only the maximal
diameter of the long axis of the largest retroperitoneal lymph node metastasis will be
recorded. Where the exact measurement is not available, it should be recorded whether the
maximal diameter of the largest RPLN measures >5cm or <5cm. The representative value for
large RPLN should NOT include the combination of all maximal diameters of all RPLN
metastases.
Regarding the pre-chemotherapy values for hemoglobin, platelet count and leukocyte count,
these must have been conducted within 30 days of initiation of chemotherapy. The highest
serum Creatinine observed during the course of chemotherapy should also be recorded - this is
not necessarily the pre-chemotherapy serum Creatinine, as the highest value may have occurred
during chemotherapy.
A VTE event is defined as either deep vein thrombosis (DVT) or pulmonary embolism (PE).
Superficial venous thrombosis or thrombophlebitis will not be considered as a VTE event. Only
bleeding events requiring medical intervention will be recorded.
Data collection will cover the period from the start of curative first line chemotherapy
until 90 days following completion of chemotherapy. Any VTE event that is present at baseline
(i.e. start of first line chemotherapy) will be recorded. Additionally, any VTE event that
occurs within 90 days of completion of chemotherapy will be recorded; this allows recording
of incidental VTE noted on post-chemotherapy restaging scans. Distinction will be made for
VTE that occurs following post-chemo surgery (post-op) that is performed within the 90 day
timeframe.
Data collection should be completed by December 31, 2015 and de-identified data forwarded to
the Principal Investigator for data analysis before January 30, 2015.
The aggregated data will be used for study reports, and where appropriate conference
presentations and peer-reviewed manuscript(s). In addition, the findings may be used to
inform the design of a subsequent prospective trial of prophylactic anticoagulation.
