Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism (SOME)
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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 |
- 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 ]
- 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 Primary Completion Date: | September 2012 (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 |
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:
- known active cancer;
- recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
- recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
- previous unprovoked VTE;
- 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:
- patients with a high/intermediate pre-test probability (Wells' model > 4) + high probability V/Q scan;
- positive pulmonary angiogram; or
- 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
Contacts and Locations| Contact: Marc Carrier, MD MSc | 613-737-8899 ext 79842 | mcarrier@ottawahospital.on.ca |
| Contact: Kim Danovitch, RT, CCRP | 613-798-5555 ext 15166 | kdanovitch@ohri.ca |
| Canada, Ontario | |
| Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Kim Danovitch, RT, CCRP 613-798-5555 ext 15166 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 | |
More Information
Publications:
| Responsible Party: | Dr. Marc Carrier, MD MSc FRCPC, Associate 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: | October 18, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
Cancer Screening |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013