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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
862
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.
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.
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Capital Health Centre for Research
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
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
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
Overall mortality
Time frame: 1 year
Recurrent VTE
Time frame: 1 year
Early malignancy: T1-2N0M0 as per the World Health Organization TNM classification system
Time frame: 1 year
QALYs gained
Time frame: 1 year
Incremental cost-effectiveness ratio
Time frame: 1 year
Adverse events with cCT
Time frame: 1 year
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