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Screening for Occult Malignancy in Patients with Unprovoked Venous Thromboembolism

NCT04304651 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1276

Last updated 2024-12-16

No results posted yet for this study

Summary

Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE.

An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).

Conditions

  • Embolism and Thrombosis

Interventions

DIAGNOSTIC_TEST

Limited cancer screening

The limited cancer screening will include: 1) a complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin); and 4) chest X-ray. In women, a breast examination, Pap smear/pelvic examination (if \< 70 years old and previously sexually active) and mammogram will be performed, if not conducted in last year. In men, similarly, prostate examination and PSA testing will be performed, if not conducted in the last year. All patients will undergo colon cancer screening as per local practice.

DIAGNOSTIC_TEST

Limited cancer screening + FDG PET/CT

The limited cancer screening (as described above) in combination with a FDG PET/CT.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2026-09-08
Completion
2030-09-08

Countries

  • Canada
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304651 on ClinicalTrials.gov