Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ottawa Health Research Institute |
---|---|
Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00773448 |
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" misses 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 two years (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: | Screening, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Screening for Previously Undiagnosed Malignancy in Patients With Unprovoked Venous Thromboembolism: a Randomized Controlled Trial Using a Comprehensive Computed Tomography of the Abdomen/Pelvis |
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 |
---|---|
Limited Malignancy Screening: Active Comparator |
Other: Limited Malignancy Screening
1) A complete medical history and physical examination; 2) complete blood count; 3) serum electrolytes (including calcium); 3) liver function tests (AST, ALT, ALP, bilirubin, LDH); 4) renal function test (creatinine); 5) chest X-ray; and 6) urinalysis. In women, a breast examination, pap smear/pelvic examination (if > 18 and < 70 years old) and mammogram (> 50 years old) will be performed if not conducted in last year. Similarly, prostate examination +/- PSA testing (>40 years old) will be performed if not conducted in the last years. |
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.
|
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:
Pulmonary embolism is defined as:
Exclusion Criteria:
Patients will be excluded from the study if they have any of the following criteria:
Contact: Marc Carrier, MD MSc | 613-737-8899 ext 79842 | mcarrier@ottawahospital.on.ca |
Contact: Melissa Spero, RN | 613-737-8899 ext 12691 | mspero@ohri.ca |
Canada, Ontario | |
Ottawa Hospital | Recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Melissa Spero, RN 613-737-8899 ext 12691 mspero@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 |
Responsible Party: | Ottawa Health Research Institute ( Marc Carrier MD MSc FRCPC, Associate Scientist ) |
Study ID Numbers: | 2004723-01H |
Study First Received: | October 14, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773448 |
Health Authority: | Canada: Ethics Review Committee |
Cancer Screening |
Calcium, Dietary Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases |
Vascular Diseases Bilirubin Venous Thrombosis Venous Thromboembolism Thromboembolism Thrombosis |
Cardiovascular Diseases |