Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism
NCT ID: NCT01088334
Last Updated: 2010-03-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Total Enrollment
630 participants
Study Classification
OBSERVATIONAL
Study Start Date
2002-12-31
Study Completion Date
2008-12-31
Brief Summary
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Background
Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE.
The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study.
Primary objective: cancer related mortality
Methods:
The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study.
Inclusion criteria:
1. Proven first symptomatic deep venous thromboembolic event;
2. Without: known risk factor for venous thromboembolism.
Exclusion criteria:
1. Proven deep venous thromboembolic event in the medical history, age under 40 years;
2. Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event).
Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis.
Endpoint: Mortality.
Statistics:
Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.
Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE.
The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study.
Primary objective: cancer related mortality
Methods:
The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study.
Inclusion criteria:
1. Proven first symptomatic deep venous thromboembolic event;
2. Without: known risk factor for venous thromboembolism.
Exclusion criteria:
1. Proven deep venous thromboembolic event in the medical history, age under 40 years;
2. Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event).
Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis.
Endpoint: Mortality.
Statistics:
Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.
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Detailed Description
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Study design:
Although a randomized design is ideal for most studies we preferred a multicenter, prospective concurrently controlled cohort study design for our study. This is based on the experiences with the SOMIT study, in which two of the members of the executive committee (MH Prins, JMMB Otten) were involved.
The SOMIT study originally was supposed to have been conducted in eight countries. Medical ethical committees in most countries however considered it unethical to conduct this randomized study. Either because of the fact that the study contained a control arm, or because the screening arm (and thus the study itself) was considered to be unethical.
Patients as well as physicians found it difficult to let fate decide whether or not a patient would be screened for cancer, even though it was not clear if screening was life-saving. Moreover, during the SOMIT study, physicians noticed that patients with IVTE had their cancer detected early if they were in the screening group. This made it even more difficult to withhold additional screening procedures in patients in the routine group.
Many physicians themselves showed a strong preference for one of the arms of the study. Therefore they did not include as many patients as they could.
With a prospective cohort design we expect to avoid these problems. Per hospital that participates in the Trousseau study the physicians in that hospital will treat the patients according to the local preference for screening or no screening. All hospitals are matched regarding their population as much as possible.
Statistics:
The prevalence of occult cancer at the time of the thrombotic episode in patients with IVTE can be estimated to be 10%. Based on the nature and stage of malignancies, it is expected that half of these patients with occult malignant disease will die during the 3 years of follow-up, resulting in a cancer-related mortality of 5%. In addition, in approximately half of the patients with malignant disease who survived for 3 years, residual or recurrent cancer will be present. Therefore, cancer-related mortality or residual or recurrent cancer will be present in 75% of the patients with occult malignant disease at presentation, i.e., in 7-8% of the patients of the study cohort. We anticipate that approximately 80% of the occult malignancies will be detected by extensive screening and that early treatment will result in a 50% to 75% reduction of the 3-year incidence of cancer-related mortality or residual or recurrent malignancy.
Although a randomized design is ideal for most studies we preferred a multicenter, prospective concurrently controlled cohort study design for our study. This is based on the experiences with the SOMIT study, in which two of the members of the executive committee (MH Prins, JMMB Otten) were involved.
The SOMIT study originally was supposed to have been conducted in eight countries. Medical ethical committees in most countries however considered it unethical to conduct this randomized study. Either because of the fact that the study contained a control arm, or because the screening arm (and thus the study itself) was considered to be unethical.
Patients as well as physicians found it difficult to let fate decide whether or not a patient would be screened for cancer, even though it was not clear if screening was life-saving. Moreover, during the SOMIT study, physicians noticed that patients with IVTE had their cancer detected early if they were in the screening group. This made it even more difficult to withhold additional screening procedures in patients in the routine group.
Many physicians themselves showed a strong preference for one of the arms of the study. Therefore they did not include as many patients as they could.
With a prospective cohort design we expect to avoid these problems. Per hospital that participates in the Trousseau study the physicians in that hospital will treat the patients according to the local preference for screening or no screening. All hospitals are matched regarding their population as much as possible.
Statistics:
The prevalence of occult cancer at the time of the thrombotic episode in patients with IVTE can be estimated to be 10%. Based on the nature and stage of malignancies, it is expected that half of these patients with occult malignant disease will die during the 3 years of follow-up, resulting in a cancer-related mortality of 5%. In addition, in approximately half of the patients with malignant disease who survived for 3 years, residual or recurrent cancer will be present. Therefore, cancer-related mortality or residual or recurrent cancer will be present in 75% of the patients with occult malignant disease at presentation, i.e., in 7-8% of the patients of the study cohort. We anticipate that approximately 80% of the occult malignancies will be detected by extensive screening and that early treatment will result in a 50% to 75% reduction of the 3-year incidence of cancer-related mortality or residual or recurrent malignancy.
Conditions
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Venous Thromboembolism
Malignancy
Study Design
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Study Time Perspective
PROSPECTIVE
Study Groups
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IVTE, follow-up
no malignancy at basal screening, no extensive screening
No interventions assigned to this group
IVTE, screening
No malignancy at basal screening, screening by means of CT-Chest/abdomen and mammography in women
screening
Intervention Type
OTHER
CT-Chest/abdomen and mammography in women
Interventions
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screening
CT-Chest/abdomen and mammography in women
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Proven first symptomatic deep venous thromboembolic event;
* No known malignancy
* Without: trauma of the legs, surgery within the last 2 months, immobilization within the last 2 months, thrombocytosis (\> 1000 x 109), clinical severe dehydration, deficiency of anti-thrombin III, protein C/S, Factor V Leiden mutation , Prothrombine mutation or circulating lupus anticoagulants, pregnancy or post-partum period
* No indication for malignancy at routine investigations(medical history, physical examination, routine blood tests and chest X-ray)
* No known malignancy
* Without: trauma of the legs, surgery within the last 2 months, immobilization within the last 2 months, thrombocytosis (\> 1000 x 109), clinical severe dehydration, deficiency of anti-thrombin III, protein C/S, Factor V Leiden mutation , Prothrombine mutation or circulating lupus anticoagulants, pregnancy or post-partum period
* No indication for malignancy at routine investigations(medical history, physical examination, routine blood tests and chest X-ray)
Exclusion Criteria
* Proven deep venous thromboembolic event in the medical history
* age under 40 years;
* age under 40 years;
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Slotervaart Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Slotervaart hospital
Principal Investigators
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Hans-Martin MB Otten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Slotervaart hospital and Academic Medical Center
Harry R Büller, Md PhD
Role: STUDY_DIRECTOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Martin H Prins, MD PhD
Role: STUDY_CHAIR
Maastricht Universitair Medisch Centrum
Frederiek F v. Doormaal, MD PhD
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Wim Terpstra, MD PhD
Role: STUDY_CHAIR
Onze Lieve Vrouwe Gasthuis
René vd Griend, MD PhD
Role: STUDY_CHAIR
Diakonessenhuis, Utrecht
Marten Nijziel, MD PhD
Role: STUDY_CHAIR
Maxima Medical Center
Marcel A vd Ree, MD PhD
Role: STUDY_CHAIR
Diakonessenhuis Zeist
Jacob C Dutilh, MD
Role: STUDY_CHAIR
Meander Medisch Centrum
A t. Cate-Hoek, MD PhD
Role: STUDY_CHAIR
Maastricht Universitair Medisch Centrum
Simone M. vd Heiligenberg, MD
Role: STUDY_CHAIR
Dijklander Ziekenhuis
Jan vd Meer, MD PhD
Role: STUDY_CHAIR
University Medical Center Groningen
Locations
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Meander Medisch Centrum
Amersfoort, , Netherlands
Site Status
Slotervaarthospital
Amsterdam, , Netherlands
Site Status
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Site Status
Academic Medical Center
Amsterdam, , Netherlands
Site Status
Maxima Medisch Centrum
Eindhoven, , Netherlands
Site Status
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
Site Status
Westfries Gasthuis
Hoorn, , Netherlands
Site Status
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Site Status
Diakonessenhuis Utrecht
Utrecht, , Netherlands
Site Status
Diakonessenhuis Zeist
Zeist, , Netherlands
Site Status
Countries
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Netherlands
References
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Rajan R, Levine M, Gent M, Hirsh J, Geerts W, Skingley P, Julian J. The occurrence of subsequent malignancy in patients presenting with deep vein thrombosis: results from a historical cohort study. Thromb Haemost. 1998 Jan;79(1):19-22.
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Prins MH, Hettiarachchi RJ, Lensing AW, Hirsh J. Newly diagnosed malignancy in patients with venous thromboembolism. Search or wait and see? Thromb Haemost. 1997 Jul;78(1):121-5.
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BACKGROUND
Lensing AW, Prandoni P, Brandjes D, Huisman PM, Vigo M, Tomasella G, Krekt J, Wouter Ten Cate J, Huisman MV, Buller HR. Detection of deep-vein thrombosis by real-time B-mode ultrasonography. N Engl J Med. 1989 Feb 9;320(6):342-5. doi: 10.1056/NEJM198902093200602.
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BACKGROUND
Sannella NA, O'Connor DJ Jr. "Idiopathic" deep venous thrombosis: the value of routine abdominal and pelvic computed tomographic scanning. Ann Vasc Surg. 1991 May;5(3):218-22. doi: 10.1007/BF02329376.
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BACKGROUND
Cornuz J, Pearson SD, Creager MA, Cook EF, Goldman L. Importance of findings on the initial evaluation for cancer in patients with symptomatic idiopathic deep venous thrombosis. Ann Intern Med. 1996 Nov 15;125(10):785-93. doi: 10.7326/0003-4819-125-10-199611150-00001.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial. Ann Intern Med. 2004 Jun 1;140(11):867-73. doi: 10.7326/0003-4819-140-11-200406010-00007.
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BACKGROUND
Girolami A, Prandoni P, Zanon E, Bagatella P, Girolami B. Venous thromboses of upper limbs are more frequently associated with occult cancer as compared with those of lower limbs. Blood Coagul Fibrinolysis. 1999 Dec;10(8):455-7. doi: 10.1097/00001721-199912000-00001.
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Ahmed Z, Mohyuddin Z. Deep vein thrombosis as a predictor of cancer. Angiology. 1996 Mar;47(3):261-5. doi: 10.1177/000331979604700307.
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Biello DR, Mattar AG, McKnight RC, Siegel BA. Ventilation-perfusion studies in suspected pulmonary embolism. AJR Am J Roentgenol. 1979 Dec;133(6):1033-7. doi: 10.2214/ajr.133.6.1033.
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Otten HM, Prins MH. A number needed to screen and cost-effectiveness analysis of the SOMIT-data. Haemostasis. 2001;31 Suppl 1:40-2. No abstract available.
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Piccioli A, Prandoni P. Screening for occult cancer in patients with idiopathic venous thromboembolism: yes. J Thromb Haemost. 2003 Nov;1(11):2271-2. doi: 10.1046/j.1538-7836.2003.00505.x. No abstract available.
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BACKGROUND
Lee AY. Screening for occult cancer in patients with idiopathic venous thromboembolism: no. J Thromb Haemost. 2003 Nov;1(11):2273-4. doi: 10.1046/j.1538-7836.2003.00490.x. No abstract available.
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BACKGROUND
Monreal M, Lensing AW, Prins MH, Bonet M, Fernandez-Llamazares J, Muchart J, Prandoni P, Jimenez JA. Screening for occult cancer in patients with acute deep vein thrombosis or pulmonary embolism. J Thromb Haemost. 2004 Jun;2(6):876-81. doi: 10.1111/j.1538-7836.2004.00721.x.
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Piccioli A, Lensing AW, Prins MH, Falanga A, Scannapieco GL, Ieran M, Cigolini M, Ambrosio GB, Monreal M, Girolami A, Prandoni P; SOMIT Investigators Group. Extensive screening for occult malignant disease in idiopathic venous thromboembolism: a prospective randomized clinical trial. J Thromb Haemost. 2004 Jun;2(6):884-9. doi: 10.1111/j.1538-7836.2004.00720.x.
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BACKGROUND
DI Nisio M, Otten HM, Piccioli A, Lensing AW, Prandoni P, Buller HR, Prins MH. Decision analysis for cancer screening in idiopathic venous thromboembolism. J Thromb Haemost. 2005 Nov;3(11):2391-6. doi: 10.1111/j.1538-7836.2005.01606.x.
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BACKGROUND
Nordstrom M, Lindblad B, Anderson H, Bergqvist D, Kjellstrom T. Deep venous thrombosis and occult malignancy: an epidemiological study. BMJ. 1994 Apr 2;308(6933):891-4. doi: 10.1136/bmj.308.6933.891.
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BACKGROUND
Sorensen HT, Mellemkjaer L, Steffensen FH, Olsen JH, Nielsen GL. The risk of a diagnosis of cancer after primary deep venous thrombosis or pulmonary embolism. N Engl J Med. 1998 Apr 23;338(17):1169-73. doi: 10.1056/NEJM199804233381701.
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BACKGROUND
Buller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695-702. doi: 10.1056/NEJMoa035451.
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BACKGROUND
Baron JA, Gridley G, Weiderpass E, Nyren O, Linet M. Venous thromboembolism and cancer. Lancet. 1998 Apr 11;351(9109):1077-80. doi: 10.1016/S0140-6736(97)10018-6.
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BACKGROUND
Beckers MM, Verzijlbergen JF, van Buul MM, Prins MH, Biesma DH. The potential role of positron emission tomography in the detection of occult cancer in 25 patients with venous thromboembolism. Ann Oncol. 2008 Jun;19(6):1203-4. doi: 10.1093/annonc/mdn156. Epub 2008 Apr 2. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
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Trousseau studie
Identifier Type: -
Identifier Source: org_study_id
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