Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04122430




Registration number
NCT04122430
Ethics application status
Date submitted
8/10/2019
Date registered
10/10/2019
Date last updated
19/10/2020

Titles & IDs
Public title
Risk of Venous Thromboembolism in Patients Receiving First-Line Chemotherapy for Disseminated Germ Cell Tumours
Scientific title
Risk of Venous Thromboembolism in Patients Receiving First-Line Chemotherapy for Disseminated Germ Cell Tumours - a Multi-Site Retrospective Cohort Study as Part of the Global Germ-Cell Cancer Group (G3) Consortium
Secondary ID [1] 0 0
QA2015168
Universal Trial Number (UTN)
Trial acronym
G3 RPLN PBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Testicular Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Cancer 0 0 0 0
Other cancer types
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Review of Health Information

GCT treated with first line chemotherapy - Men with disseminated Germ Cell Tumours-GCT (AJCC Stage IS, 2, or 3) and have received first line chemotherapy with curative intent for disseminated GCT
.


Other interventions: Review of Health Information
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
March 2016
Secondary outcome [1] 0 0
To assess the discriminatory accuracy for VTE of both large RPLN metastases and high-risk Khorana score (defined as > 3)
Timepoint [1] 0 0
March 2016
Secondary outcome [2] 0 0
To determine the incidence of VTE in patients with disseminated GCT receiving first line chemotherapy at baseline, during chemotherapy and immediately following chemotherapy
Timepoint [2] 0 0
March 2016
Secondary outcome [3] 0 0
To determine the incidence of VTE during and immediately after chemotherapy in patients receiving prophylactic anticoagulation during first line chemotherapy for disseminated GCT
Timepoint [3] 0 0
March 2016
Secondary outcome [4] 0 0
To determine the incidence of major bleeding in patients who received prophylactic anticoagulation versus those who did not
Timepoint [4] 0 0
March 2016
Secondary outcome [5] 0 0
To determine overall survival at 12 months, 3 years and 5 years for patients who developed VTE compared to those who did not.
Timepoint [5] 0 0
March 2016

Eligibility
Key inclusion criteria
1. Men with disseminated GCT (AJCC Stage IS, 2, or 3)

2. Received first line chemotherapy with curative intent for disseminated GCT

3. Clinical data available from chemotherapy initiation to at least 90 days following
completion of chemotherapy (patients who died prior to 90 days will be included in
this study)

4. Initiated chemotherapy between 1-January-2000 and 31-December-2014* *Data collection
from consecutive patients initiating chemotherapy during a defined period within the
specified timeframe is acceptable (e.g. patient data from 5-year period starting
1-January-2008 and ending 31-December-2012 is acceptable)
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior chemotherapy for GCT (including use of adjuvant chemotherapy or curative
chemotherapy for prior diagnosis of disseminated GCT).

2. History of secondary malignancy (excluding non-melanoma superficial skin cancers)

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2020
Sample size
Target
Accrual to date
Final
1135
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Walter and Eliza Hall Institute of Medical Research - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Marsden NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Melbourne Health
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04122430
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ben Tran, Medicine
Address 0 0
Walter and Eliza Hall Institute of Medical Resaerch
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04122430