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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00773448
Other study ID # 2004723-01H
Secondary ID
Status Completed
Phase N/A
First received October 14, 2008
Last updated July 2, 2015
Start date September 2008
Est. completion date April 2015

Study information

Verified date July 2015
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 862
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

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

Exclusion Criteria:

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;

- Greater than 21 days post diagnosis of idiopathic VTE

- Index VTE event of UEDVT or unusual site DVT

- Diagnosis of SSPE in the absence of above or below knee DVT

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Intervention

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.

Locations

Country Name City State
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 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 Ottawa Hospital Ottawa Ontario
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Carrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult — View Citation

Carrier M, Le Gal G, Wells PS, Fergusson D, Ramsay T, Rodger MA. Systematic review: the Trousseau syndrome revisited: should we screen extensively for cancer in patients with venous thromboembolism? Ann Intern Med. 2008 Sep 2;149(5):323-33. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year No
Secondary Overall mortality 1 year No
Secondary Recurrent VTE 1 year No
Secondary Early malignancy: T1-2N0M0 as per the World Health Organization TNM classification system 1 year No
Secondary QALYs gained 1 year No
Secondary Incremental cost-effectiveness ratio 1 year No
Secondary Adverse events with cCT 1 year Yes
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