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Clinical Trials/NCT07210671
NCT07210671RecruitingNot Applicable

Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous

Centre Hospitalier Universitaire, Amiens1 site in 1 country1,576 target enrollmentStarted: November 10, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,576
Locations
1
Primary Endpoint
risk (in %) of recurrence of VTE
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Superficial venous thrombosis (SVT) is very common in clinical practice. What's more, around 15- 20% of SVTs occur in the context of cancer. Today, cancer patients are excluded from therapeutic trials for DVT. There is therefore no high-level evidence-based treatment recommendation for these patients. Recent data suggest that the course of cancer-associated DVT is similar to that of cancer-associated deep vein thrombosis (DVT). However, there are currently few prospective data on the evolution of cancer-associated DVT in relation to the treatment used. Due to the absence of clear recommendations of treatment in case of SVT associated with cancer the investigators will perform a prospective observational study to evaluate the efficacy of different regiment of anticoagulant treatment ordered in clinical practice.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient over 18
  • •Patient affiliated to a social security scheme
  • •Patient who understands French
  • •Patient with superficial venous thrombosis of the lower and upper limbs confirmed by a Doppler ultrasound less than one month old.
  • •Patient with active cancer:
  • •Cancer treatment within the last 6 months,
  • •Detectable tumor disease, cancer treatment within the last 6 months, ongoing hormone therapy for cancer, palliative cancer.
  • •The patient has received potentially non-curative cancer treatment (notably palliative chemotherapy).
  • •Progression shows that the cancer treatment was not curative (due to recurrence or progression under treatment) (particularly in the case of recurrence after surgery)

Exclusion Criteria

  • •Patients under legal protection
  • •Patients with concomitant pulmonary embolism
  • •Patient with proximal or distal deep vein thrombosis
  • •Patient treated with anticoagulant therapy for another indication
  • •Patient with a contraindication to anticoagulation: Thrombocytopenia less than 30,000 elements/mm3, active bleeding or history of severe bleeding.
  • •Patient opposed to participation in research

Outcomes

Primary Outcomes

risk (in %) of recurrence of VTE

Time Frame: at 3-month follow-up

risk of recurrence of VTE at 3-month follow-up in patients with cancer-associated SVT.

Secondary Outcomes

  • rates of recurrence of symptomatic vs. incidental VTE(at 12 months)
  • association (%) between initial treatment and the risk of SVT recurrence(at 3 months)
  • association (%) between initial treatment and the risk of SVT recurrence(at 6 months)
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 12 months)
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 3 months)
  • Association (%) between initial treatment and the occurrence of DVT(at 3 months)
  • Association (%) between initial treatment and the occurrence of DVT(at 12 months)
  • association (%) between initial treatment and bleeding events(at 6 months)
  • association (%) between initial treatment and bleeding events(at 3 months)
  • association(%) between initial treatment and all-cause death(at 3 months)
  • association(%) between initial treatment and all-cause death(at 6 months)
  • rates of recurrence of symptomatic vs. incidental VTE(at 3 months)
  • rates of recurrence of symptomatic vs. incidental VTE(at 6 months)
  • association(%) between initial treatment and all-cause death(at 12 months)
  • association (%) between initial treatment and the risk of SVT recurrence(at 12 months)
  • association (%) between initial treatment and bleeding events(at 12 months)
  • Association (%) between initial treatment and the occurrence of pulmonary embolism (PE)(at 6 months)
  • Association (%) between initial treatment and the occurrence of DVT(at 6 months)
  • rate of confirmed cancer in patients with TVS suspected of having cancer.(at 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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