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Venous ThromboembolismSOMENCT00773448

Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism

A study testing Comprehensive computed tomography of the abdomen/pelvis and Limited Malignancy Screening in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Ottawa Hospital Research Institute at 9 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Comprehensive computed tomography of the abdomen/pelvis and Limited Malignancy Screening
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
862 participants
Where
9 sitesCanada
Study dates
Sep 2008to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • known active cancer;
  • recent (less than 3 months) paralysis, paresis or plaster immobilization of the lower extremities;
  • recently bedridden for period of 3 or more days, or major surgery, within the previous 12 weeks requiring general or regional anaesthesia;
  • previous unprovoked VTE;
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  • 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:
  • patients with a high/intermediate pre-test probability (Wells' model > 4) + high probability V/Q scan;
  • positive pulmonary angiogram; or
  • spiral CT demonstrating intraluminal filling defect in a vessel larger than a segmental artery

Who cannot join

  • 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
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  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • Capital Health Centre for Research

    Halifax, Nova Scotia

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario

  • London Health Sciences Center

    London, Ontario

  • Montreal General Hospital

    Montreal, Quebec

  • Sacre-Coeur Hospital

    Montreal, Quebec

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec

  • St. Mary's Hospital Center

    Montreal, Quebec

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • St. Boniface Hospital

    Winnipeg, Manitoba

Other trials in Canada

About this study

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.

Read more

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.

Being tested
Comprehensive computed tomography of the abdomen/pelvis, Limited Malignancy Screening
Keywords
Cancer, Screening
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comprehensive computed tomography of the abdomen/pelvisDevice

    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.

  • Limited Malignancy ScreeningOther

    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.

Study groups in NCT00773448
Study groupRoleWhat they receive
Limited Malignancy ScreeningActive comparatorNot described
Receives: Other: Limited Malignancy Screening
Extensive Malignancy ScreeningExperimentalLimited screen as described above in combination with comprehensive computed tomography of the abdomen/pelvis
Receives: Device: Comprehensive computed tomography of the abdomen/pelvis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (6)

  1. Overall mortality

    Measured: 1 year

  2. Recurrent VTE

    Measured: 1 year

  3. Early malignancy: T1-2N0M0 as per the World Health Organization TNM classification system

    Measured: 1 year

  4. QALYs gained

    Measured: 1 year

  5. Incremental cost-effectiveness ratio

    Measured: 1 year

  6. Adverse events with cCT

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
862 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00773448
Sponsor's protocol ID
2004723-01H
Acronym
SOME
Status last verified
Jul 2015
First submitted
14 Oct 2008
Last updated
7 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.7326/0003-4819-149-5-200809020-00007.

    PubMed 18765702

  • 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 Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22.

    PubMed 26095467

  • Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10(10):CD010837. doi: 10.1002/14651858.CD010837.pub5.

    PubMed 34597414

  • Ihaddadene R, Corsi DJ, Lazo-Langner A, Shivakumar S, Zarychanski R, Tagalakis V, Solymoss S, Routhier N, Douketis J, Le Gal G, Carrier M. Risk factors predictive of occult cancer detection in patients with unprovoked venous thromboembolism. Blood. 2016 Apr 21;127(16):2035-7. doi: 10.1182/blood-2015-11-682963. Epub 2016 Jan 27.

    PubMed 26817957

Questions about this trial

What is this clinical trial studying?

A study testing Comprehensive computed tomography of the abdomen/pelvis and Limited Malignancy Screening in people with Venous Thromboembolism and Deep Vein Thrombosis, run by Ottawa Hospital Research Institute at 9 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00773448, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.

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