Last updated: 03/05/2020 20:40:12
This study has been divested to Aspen, GSK will not produce a result
Risk score for venous thromboembolism
GSK study ID
113822
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Risk score for venous thromboembolism
Trial description: Development and validation of a score of risk of venous thrombosis event occurrence in patients with cancer, derived from clinical and biological parameters.This an epidemiological, prospective and longitudinal study in two parts : - collection of clinical and biological information from patients with cancer ; - monitoring of thrombosis events within a 6-month period.The population of the study will consist in a first sample (derivation cohort) used to identify parameters that may be included in the score of risk and a second sample (validation cohort) that will unable the validation of the score.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Thrombosis event score of risk definition derived from biological, clinical parameters as measured at baseline and 6 months
Timeframe: within a 6 months period
Secondary outcomes:
Description of thrombosis events
Timeframe: within a 6 months period
- Description of the estimation of the score of risk according to cancer type, localization, status
Timeframe: within a 6 months period
Interventions:
Other: Thrombosis event score of risk definition derived from biological, clinical parameters as measured at baseline and 6 months
Enrollment:
699
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
April 2013 to February 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Male or female patient, older than 18 years old,
- patient with a metastatic cancer or with a stomach - ovary - pancreas- lung - kidney or testis cancer
- patient under guardian or guardianship
- patient on palliative unit
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female patient, older than 18 years old,
- patient with a metastatic cancer or with a stomach
- ovary
- pancreas- lung
- kidney or testis cancer
- patient whose cancer is on treatment process or treatment is planned or has been treated (less than 3 years) by chemotherapy or radiotherapy or hormonotherapy or targeted therapy
- patient agreed to give a blood sample at the first visit (inform consent given)
Exclusion criteria:
- patient under guardian or guardianship
- patient on palliative unit
- patient with an hematopoietic cancer
- patient with a Life expectancy of at least three months
- patient with an indication of curative dose of anticoagulant in the long term
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2015-10-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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