Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism

Pulmonary Embolism Clinical Trial

— SOME  

Official title:

Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism: an Open Randomized Controlled Trial Using a Comprehensive Abdomen/Pelvis Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773448
• Other study ID #: 2004723-01H
• 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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism
• Venous Thrombosis

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