An interventional study of Comprehensive computed tomography of the abdomen/pelvis and Limited Malignancy Screening in Venous Thromboembolism, Deep Vein Thrombosis and Pulmonary Embolism, sponsored by Ottawa Hospital Research Institute. Completed at 9 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-07.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Screening
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 862 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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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:
Pulmonary embolism is defined as:
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following criteria:
Other: Limited 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.
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.
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
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute