Risk of Venous Thromboembolism in Patients Receiving First-Line Chemotherapy for Disseminated Germ Cell Tumours

NCT04122430 | Completed DMC

• 1 other identifier: QA2015168
• Study Type: observational
• Target: 1,135
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  March 2016

Secondary Outcomes (5)

• To assess the discriminatory accuracy for VTE of both large RPLN metastases and high-risk Khorana score (defined as > 3)

  March 2016

• To determine the incidence of VTE in patients with disseminated GCT receiving first line chemotherapy at baseline, during chemotherapy and immediately following chemotherapy

  March 2016

• To determine the incidence of VTE during and immediately after chemotherapy in patients receiving prophylactic anticoagulation during first line chemotherapy for disseminated GCT

  March 2016

• To determine the incidence of major bleeding in patients who received prophylactic anticoagulation versus those who did not

  March 2016

• To determine overall survival at 12 months, 3 years and 5 years for patients who developed VTE compared to those who did not.

  March 2016

Study Arms (1)

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: Review of Health Information

Interventions

Review of Health Information OTHER

GCT treated with first line chemotherapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with disseminated GCT (AJCC Stage IS, 2, or 3) who have received first line chemotherapy with curative intent for disseminated GCT. 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) and initiated chemotherapy between 1-January-2000 and 31-December-2014.

You may qualify if:

• Men with disseminated GCT (AJCC Stage IS, 2, or 3)
• Received first line chemotherapy with curative intent for disseminated GCT
• 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)
• 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)

You may not qualify if:

• Prior chemotherapy for GCT (including use of adjuvant chemotherapy or curative chemotherapy for prior diagnosis of disseminated GCT).
• History of secondary malignancy (excluding non-melanoma superficial skin cancers)

Sponsors & Collaborators

• Walter and Eliza Hall Institute of Medical Research: lead
• Royal Marsden NHS Foundation Trust: collaborator
• Melbourne Health: collaborator

Study Sites (1)

Walter and Eliza Hall Institute of Medical Research

Parkville, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Ben Tran, Medicine

  Walter and Eliza Hall Institute of Medical Resaerch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist/Clinical Researcher

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 10, 2019
• Study Start: December 1, 2015
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)