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
  Purpose

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 Intervention
Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Device: Comprehensive computed tomography of the abdomen/pelvis
Other: Limited Malignancy Screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 862
Study Start Date: September 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773448

Contacts
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

Locations
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada
Contact: Ryan Zarychanski, MD       Ryan.Zarychanski@cancercare.mb.ca   
Principal Investigator: Ryan Zarychanski, MD         
Canada, Nova Scotia
Capital Health Centre for Research Recruiting
Halifax, Nova Scotia, Canada
Contact: Sudeep Shivakumar, MD       Sudeep.Shivakumar@cdha.nshealth.ca   
Principal Investigator: Sudeep Shivakumar, MD         
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada
Contact: James Douketis, MD       jdouket@mcmaster.ca   
Principal Investigator: James Douketis, MD         
London Health Sciences Center Recruiting
London, Ontario, Canada
Contact: Alejandro Lazo-Langner, MD       Alejandro.LazoLangner@lhsc.on.ca   
Principal Investigator: Alejandro Lazo-Langner, MD         
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Kim Danovitch, CCRP    613-737-8899 ext 73667    kdanovitch@ohri.ca   
Principal Investigator: Marc Carrier, MD MSc         
Sub-Investigator: Marc A Rodger, MD MSc         
Sub-Investigator: Philip S Wells, MD MSc         
Sub-Investigator: Tim Ramsay, PhD         
Canada, Quebec
Sir Mortimer B. Davis Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Vicky Tagalakis, MD       vicky.tagalakis@mcgill.ca   
Principal Investigator: Vicky Tagalakis, MD         
Sacre-Coeur Hospital Recruiting
Montreal, Quebec, Canada
Contact: Nathalie Routhier, MD       nathalie.routhier@gmail.com   
Principal Investigator: Nathalie Routhier, MD         
Montreal General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Susan Solymoss, MD       susan.solymoss@mcgill.ca   
Principal Investigator: Susan Solymoss, MD         
St. Mary's Hospital Center Recruiting
Montreal, Quebec, Canada
Contact: Susan Solymoss, MD       susan.solymoss@mcgill.ca   
Principal Investigator: Susan Solymoss, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Marc Carrier, MD MSc FRCPC The Ottawa Hospital Research Institute
  More Information

Publications:
Responsible Party: Marc Carrier, MD, MD MSc FRCPC, Scientist., Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00773448     History of Changes
Other Study ID Numbers: 2004723-01H
Study First Received: October 14, 2008
Last Updated: November 7, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Cancer
Screening

Additional relevant MeSH terms:
Venous Thrombosis
Venous Thromboembolism
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014