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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Marc Carrier, MD, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00773448
First received: October 14, 2008
Last updated: November 7, 2013
Last verified: November 2013

October 14, 2008
November 7, 2013
September 2008
June 2015   (final data collection date for primary 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773448 on ClinicalTrials.gov Archive Site
  • Overall mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Recurrent VTE [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Early malignancy: T1-2N0M0 as per the World Health Organization TNM classification system [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • QALYs gained [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness ratio [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Adverse events with cCT [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Venous Thromboembolism
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • 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.
  • 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.

  • Active Comparator: Limited Malignancy Screening
    Intervention: Other: Limited Malignancy Screening
  • Experimental: Extensive Malignancy Screening
    Limited screen as described above in combination with comprehensive computed tomography of the abdomen/pelvis
    Intervention: Device: Comprehensive computed tomography of the abdomen/pelvis
Carrier M, Le Gal G, Wells PS, Fergusson D, Ramsay T, Rodger MA. Systematic review: the Trousseau syndrome revisited: should we screen extensively for cancer in patients with venous thromboembolism? Ann Intern Med. 2008 Sep 2;149(5):323-33. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
862
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marc Carrier, MD MSc 613-737-8899 ext 73034 mcarrier@ottawahospital.on.ca
Contact: Kim Danovitch, CCRP 613-737-8899 ext 73667 kdanovitch@ohri.ca
Canada
 
NCT00773448
2004723-01H
Yes
Marc Carrier, MD, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: Marc Carrier, MD MSc FRCPC The Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP