PROSPECTIVE EVALUATION OF THE TREATMENT OF CANCER- ASSOCIATED SUPERFICIAL VENOUS

Not yet recruiting

• Conditions: Superficial Vein Thrombosis; Cancer; Venous Thrombosis

• Registration Number: NCT07210671
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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 recommandations 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2027-10
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1576

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
risk (in %) of recurrence of VTE	at 3-month follow-up	risk of recurrence of VTE at 3-month follow-up in patients with cancer-associated SVT.

Secondary Outcome Measures

Name	Time	Method
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
rates of recurrence of symptomatic vs. incidental VTE	at 12 months
rate of confirmed cancer in patients with TVS suspected of having cancer.	at 12 months

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France