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Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism (SOME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773448
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : July 7, 2015
Information provided by (Responsible Party):
Marc Carrier, MD, Ottawa Hospital Research Institute

Brief Summary:

Blood clots in leg veins (deep vein thrombosis) or lung arteries (pulmonary embolism) that happen for no reason (i.e. unexplained) are both called "unprovoked venous thromboembolism" (VTE). These unexplained blood clots can be the first symptom of cancer. Up to 10% of patients with unexplained blood clots will be diagnosed with cancer within one year of their blood clot diagnosis.

These cancers can be found anywhere in the body although the relationship appears stronger with the pancreas, ovary and liver. Cancer testing in patients with blood clots is controversial. There is presently a wide variety of expert opinions and practices. Previous studies showed that a limited cancer screen including a medical history, physical examination, basic blood work and chest X-ray, will find about 90% of cancers. More recent and better designed studies showed that the limited cancer screen misses many cancers and needs to be improved. More extensive cancer testing may find more cancers but is potentially uncomfortable for patients, costs a lot of money and involves a lot of people.

The "comprehensive computed tomography" is less uncomfortable, inexpensive, radiological test made to find many cancers at once. Thus, the scientific question to be asked is: Does a "comprehensive computed tomography" miss less cancers than a limited cancer screen in patients with blood clots?

The main goal of this study is to find out if a "comprehensive computed tomography" misses less cancers than a limited cancer screen in patients with unexplained blood clots.

The second goal of the study is 1) to find out if a "comprehensive computed tomography" finds more "curable" cancers than the limited cancer screen; 2) to find out if the patients diagnosed with cancer are still alive and cancer-free after one year (i.e. the patients with curable cancer were treated and are doing well); 3) to prove that a negative "comprehensive computed tomography" means that the patient will not have cancer and; 4) to find out if a "comprehensive computed tomography" is well tolerated and safe for patients.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism Device: Comprehensive computed tomography of the abdomen/pelvis Other: Limited Malignancy Screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 862 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography
Study Start Date : September 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arm Intervention/treatment
Active Comparator: Limited Malignancy Screening Other: Limited Malignancy Screening

1) A complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin, LDH); 4) renal function test (creatinine); 5) chest X-ray (if not performed in the past year)

In women, a pap smear/pelvic examination (if > 18 and < 70 years old and not performed during the past year),a mammogram (> 50 years old) will be performed if not conducted in last year. Similarly for men, prostate examination +/- PSA testing (>40 years old) will be performed if not conducted in the past year.

Experimental: Extensive Malignancy Screening
Limited screen as described above in combination with comprehensive computed tomography of the abdomen/pelvis
Device: Comprehensive computed tomography of the abdomen/pelvis
Virtual colonoscopy and gastroscopy, a biphasic enhanced CT for hepatoma and renal cell carcinoma, parenchymal pancreatogram with minimum intensity projection (MinIP) reformation for pancreatic carcinoma, and finally uniphasic enhanced CT of distended bladder for bladder and ovarian carcinomas.

Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall mortality [ Time Frame: 1 year ]
  2. Recurrent VTE [ Time Frame: 1 year ]
  3. Early malignancy: T1-2N0M0 as per the World Health Organization TNM classification system [ Time Frame: 1 year ]
  4. QALYs gained [ Time Frame: 1 year ]
  5. Incremental cost-effectiveness ratio [ Time Frame: 1 year ]
  6. Adverse events with cCT [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  • Greater than 21 days post diagnosis of idiopathic VTE
  • Index VTE event of UEDVT or unusual site DVT
  • Diagnosis of SSPE in the absence of above or below knee DVT
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773448

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Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Capital Health Centre for Research
Halifax, Nova Scotia, Canada
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada
Sacre-Coeur Hospital
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
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Principal Investigator: Marc Carrier, MD MSc FRCPC The Ottawa Hospital Research Institute

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marc Carrier, MD, MD MSc FRCPC, Scientist., Ottawa Hospital Research Institute Identifier: NCT00773448    
Other Study ID Numbers: 2004723-01H
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015
Keywords provided by Marc Carrier, MD, Ottawa Hospital Research Institute:
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases