FREE TREATMENT REPORT
See ratings and reviews when you sign up for an account.
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography
This study is currently Recruiting
October 2011 By Ottawa Hospital Research Institute
First Recieved on October 14, 2008
Last Updated on October 18, 2011
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.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Limited Malignancy Screening:Active Comparator|
|Extensive Malignancy Screening:Experimental|
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.
|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.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
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
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