Clinical trial · Observational
Risk of Venous Thromboembolism in Patients Receiving First-Line Chemotherapy for Disseminated Germ Cell Tumours
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Neoplasms | Testicular Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Review of Health Information | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GCT treated with first line chemotherapy
- description
- 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 .
- interventionNames
- Other: Review of Health Information
Primary outcomes (1)
- measure
- 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
- timeFrame
- March 2016
Secondary outcomes (5)
- measure
- To assess the discriminatory accuracy for VTE of both large RPLN metastases and high-risk Khorana score (defined as > 3)
- timeFrame
- March 2016
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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) 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)
References
Publications (0)
Data not yet available