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
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    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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