Prospective Evaluation of the Treatment of Cancer Associated Superficial Venous (SUPERCAT)

April 9, 2026 updated by: Centre Hospitalier Universitaire, Amiens
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens
        • Principal Investigator:
          • Laurent BERTOLETTI, MD
        • Contact:
        • Principal Investigator:
          • Lina Khider, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3-month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Actual)

October 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2024_843_0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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