Pulmonary Embolism Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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