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Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography


N/A
18 Years
N/A
Open (Enrolling)
Both
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism

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Trial Information

Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography


Inclusion Criteria:



- Patients with a new diagnosis of unprovoked proximal deep vein thrombosis (DVT) or
pulmonary embolism (PE) will be eligible to participate into the study:

- Unprovoked VTE is defined as the absence of any of the following predisposing
factors:

1. known active cancer;

2. recent (less than 3 months) paralysis, paresis or plaster immobilization of
the lower extremities;

3. recently bedridden for period of 3 or more days, or major surgery, within
the previous 12 weeks requiring general or regional anaesthesia;

4. previous unprovoked VTE;

5. known thrombophilia (hereditary or acquired)

- Proximal DVT is defined as a non-compressibility of any vein segment from the
common femoral vein to the trifurcation of the popliteal vein or a persistent
intra-luminal filling defect of the iliac, common femoral, superficial femoral
or popliteal veins on contrast venography.

- Pulmonary embolism is defined as:

1. patients with a high/intermediate pre-test probability (Wells' model > 4) +
high probability V/Q scan;

2. positive pulmonary angiogram; or

3. spiral CT demonstrating intraluminal filling defect in a vessel larger than
a segmental artery

Exclusion Criteria:

Patients will be excluded from the study if they have any of the following criteria:

- Age < 18 years-old;

- Refusal or inability to provide informed consent;

- Allergy to contrast media;

- Creatinine clearance < 60 ml/min;

- Claustrophobia or agoraphobia;

- Weight > 130 kg;

- Diagnosis of ulcerative colitis; and

- Diagnosis of glaucoma

- Current pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Previously undiagnosed malignancy "missed" by malignancy screening defined as biopsy proven tissue diagnosis of malignancy diagnosed from the time of malignancy screening completion to the end of the 1 year follow-up period.

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

Canada: Ethics Review Committee

Study ID:

2004723-01H

NCT ID:

NCT00773448

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Cancer
  • Screening
  • Embolism
  • Pulmonary Embolism
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

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