Venous ThromboembolismTrousseauNCT01088334
Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism
An observational study of Venous Thromboembolism and Malignancy, run by Slotervaart Hospital at 10 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thromboembolism, Malignancy
- What is being tested?
- screening
- How many people
- 630 participants
- Where
- 10 sitesNetherlands
- Study dates
- Dec 2002to Dec 2008
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with IVTE diagnosed in academical centres and teaching hospitals in the Netherlands
Who may be able to join
- 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)
Who cannot join
- Proven deep venous thromboembolic event in the medical history
- age under 40 years;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Meander Medisch Centrum
Amersfoort, 3818 ES
Slotervaarthospital
Amsterdam, 1066 EC
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1090 HM
Academic Medical Center
Amsterdam, 1101 AZ
Maxima Medisch Centrum
Eindhoven, 5631 BM
Academisch Ziekenhuis Groningen
Groningen, 9713 GZ
Westfries Gasthuis
Hoorn, 1624 NP
Academisch Ziekenhuis Maastricht
Maastricht, 6229 HX
Diakonessenhuis Utrecht
Utrecht, 3582 KE
Diakonessenhuis Zeist
Zeist, 3707 HL
About this study
Official title: Trousseau Studie, Mortaliteit Door Maligniteit Bij patiënten Met Idiopatische Veneuze Tromboembolie
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.
Read more
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:
- Proven first symptomatic deep venous thromboembolic event;
- Without: known risk factor for venous thromboembolism.
Exclusion criteria:
- Proven deep venous thromboembolic event in the medical history, age under 40 years;
- 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.
Read the detailed description
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.
- Conditions
- Venous Thromboembolism, Malignancy
- Being tested
- screening
- Keywords
- Idiopathic venous thromboembolism, Malignancy, screening
- Medical subject headings
- Venous Thromboembolism, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningOther
CT-Chest/abdomen and mammography in women
| Study group | Role | What they receive |
|---|---|---|
| IVTE, follow-up | no malignancy at basal screening, no extensive screening | |
| IVTE, screening | No malignancy at basal screening, screening by means of CT-Chest/abdomen and mammography in women Receives: Other: screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The responsible physician inform the investigators when a patient has died. The national registrar was checked at the end of the study for all patients
Measured: at 3, 6, 12, 24, 36 months after inclusion and at the end of study
Secondary outcomes (5)
Residual objectified malignancy
The responsible physician documented all investigations performed. The malignancy have to be objectified. At the end of the study all living patients were contacted for medical status.
Measured: at 3, 6, 12, 24, 36 months after inclusion
Recurrent objectified malignancy
The responsible physician documented all investigations performed. The malignancy have to be objectified. At the end of the study all living patients were contacted for medical status.
Measured: at 3, 6, 12, 24, 36 after inclusion.
Malignancy detected by extensive screening, without alarm signs in routine examinations
The responsible physician documented all investigations performed and documented in standardized manner the routine tests (medical history, physical examination, lab tests and Chest X-ray. The malignancy have to be objectified inconnection with and due to screening tests and eventually further investigations.
Measured: at 3 months after inclusion
Costs of screening, of additional tests after screening
All costs of routine tests (consult of phycisians, lab tests, X-Chest) are known and documented, as are the costs of the screening tests and, if performed the costs of further evaluation in case of additional tests, admitions etc..
Measured: at end of study.
Medical complications of screening tests
The screening tests had no risk of damage other than radiation. The results of these tests however could urge for invasive tests that could potentially harm patients. Therefore the harm done by screening tests or the resulting tests were documented.
Measured: at 3 + 6 months and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startDec 2002
- Primary completionMay 2008
- Study completionDec 2008
Why it stopped: Terminated because of futility to continue, after planned interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slotervaart Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Martin MB Otten, MD PhD, Principal investigator, Slotervaart hospital and Academic Medical CenterHarry R Büller, Md PhD, Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Martin H Prins, MD PhD, Study chair, Maastricht Universitair Medisch CentrumFrederiek F v. Doormaal, MD PhD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Wim Terpstra, MD PhD, Study chair, Onze Lieve Vrouwe GasthuisRené vd Griend, MD PhD, Study chair, Diakonessenhuis, UtrechtMarten Nijziel, MD PhD, Study chair, Maxima Medical CenterMarcel A vd Ree, MD PhD, Study chair, Diakonessenhuis Zeist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088334
- Sponsor's protocol ID
- Trousseau studie
- Acronym
- Trousseau
- Status last verified
- Mar 2010
- First submitted
- 25 Feb 2010
- Last updated
- 29 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bastounis EA, Karayiannakis AJ, Makri GG, Alexiou D, Papalambros EL. The incidence of occult cancer in patients with deep venous thrombosis: a prospective study. J Intern Med. 1996 Feb;239(2):153-6. doi: 10.1046/j.1365-2796.1996.426000.x.
PubMed 8568483Carson JL, Kelley MA, Duff A, Weg JG, Fulkerson WJ, Palevsky HI, Schwartz JS, Thompson BT, Popovich J Jr, Hobbins TE, et al. The clinical course of pulmonary embolism. N Engl J Med. 1992 May 7;326(19):1240-5. doi: 10.1056/NEJM199205073261902.
PubMed 1560799Griffin MR, Stanson AW, Brown ML, Hauser MF, O'Fallon WM, Anderson HM, Kazmier FJ, Melton LJ 3rd. Deep venous thrombosis and pulmonary embolism. Risk of subsequent malignant neoplasms. Arch Intern Med. 1987 Nov;147(11):1907-11.
PubMed 3675090Goldberg RJ, Seneff M, Gore JM, Anderson FA Jr, Greene HL, Wheeler HB, Dalen JE. Occult malignant neoplasm in patients with deep venous thrombosis. Arch Intern Med. 1987 Feb;147(2):251-3.
PubMed 3813741Monreal M, Salvador R, Soriano V, Sabria M. Cancer and deep venous thrombosis. Arch Intern Med. 1988 Feb;148(2):485. No abstract available.
PubMed 3341848Gore JM, Appelbaum JS, Greene HL, Dexter L, Dalen JE. Occult cancer in patients with acute pulmonary embolism. Ann Intern Med. 1982 May;96(5):556-60. doi: 10.7326/0003-4819-96-5-556.
PubMed 7073147Monreal M, Lafoz E, Casals A, Inaraja L, Montserrat E, Callejas JM, Martorell A. Occult cancer in patients with deep venous thrombosis. A systematic approach. Cancer. 1991 Jan 15;67(2):541-5. doi: 10.1002/1097-0142(19910115)67:23.0.co;2-j.
PubMed 1985747Aderka D, Brown A, Zelikovski A, Pinkhas J. Idiopathic deep vein thrombosis in an apparently healthy patient as a premonitory sign of occult cancer. Cancer. 1986 May 1;57(9):1846-9. doi: 10.1002/1097-0142(19860501)57:93.0.co;2-3.
PubMed 3955523Hettiarachchi RJ, Lok J, Prins MH, Buller HR, Prandoni P. Undiagnosed malignancy in patients with deep vein thrombosis: incidence, risk indicators, and diagnosis. Cancer. 1998 Jul 1;83(1):180-5. doi: 10.1002/(sici)1097-0142(19980701)83:13.0.co;2-s.
PubMed 9655309Monreal M, Fernandez-Llamazares J, Perandreu J, Urrutia A, Sahuquillo JC, Contel E. Occult cancer in patients with venous thromboembolism: which patients, which cancers. Thromb Haemost. 1997 Nov;78(5):1316-8.
PubMed 9408011Rajan 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.
PubMed 9459315Prins 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.
PubMed 9198140O'Connor NT, Cederholm-Williams SA, Fletcher EW, Allington M, Sharp AA. Significance of idiopathic deep venous thrombosis. Postgrad Med J. 1984 Apr;60(702):275-7. doi: 10.1136/pgmj.60.702.275.
PubMed 6539470Prandoni P, Lensing AW, Buller HR, Cogo A, Prins MH, Cattelan AM, Cuppini S, Noventa F, ten Cate JW. Deep-vein thrombosis and the incidence of subsequent symptomatic cancer. N Engl J Med. 1992 Oct 15;327(16):1128-33. doi: 10.1056/NEJM199210153271604.
PubMed 1528208Lensing 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.
PubMed 2643771
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trousseau Studie, Mortaliteit Door Maligniteit Bij patiënten Met Idiopatische Veneuze Tromboembolie
- ClinicalTrials.gov ID
- NCT01088334
- Acronym / sponsor ID
- Trousseau / Trousseau studie
- Conditions
- Venous Thromboembolism, Malignancy
- Keywords
- Idiopathic venous thromboembolism, Malignancy, screening
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated because of futility to continue, after planned interim analysis.
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Slotervaart HospitalUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- May 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Proven first symptomatic deep venous thromboembolic event;
- Without: known risk factor for venous thromboembolism.
Exclusion criteria:
- Proven deep venous thromboembolic event in the medical history, age under 40 years;
- 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.
Detailed description
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVTE, follow-up | – | –no malignancy at basal screening, no extensive screening |
| IVTE, screening | – | Other: screeningNo malignancy at basal screening, screening by means of CT-Chest/abdomen and mammography in women |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with IVTE diagnosed in academical centres and teaching hospitals in the Netherlands
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Proven deep venous thromboembolic event in the medical history
- age under 40 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screeningCT-Chest/abdomen and mammography in women | Other | IVTE, screening |
Primary outcome
Mortality
Time frame: at 3, 6, 12, 24, 36 months after inclusion and at the end of study
The responsible physician inform the investigators when a patient has died. The national registrar was checked at the end of the study for all patients
5 secondary outcomes
Residual objectified malignancy
Time frame: at 3, 6, 12, 24, 36 months after inclusion
Recurrent objectified malignancy
Time frame: at 3, 6, 12, 24, 36 after inclusion.
Malignancy detected by extensive screening, without alarm signs in routine examinations
Time frame: at 3 months after inclusion
Costs of screening, of additional tests after screening
Time frame: at end of study.
Medical complications of screening tests
Time frame: at 3 + 6 months and end of study
Results and safety
The study was stopped early (reason given: Terminated because of futility to continue, after planned interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2010.
- Background: PubMed 8568483Bastounis EA, Karayiannakis AJ, Makri GG, Alexiou D, Papalambros EL. The incidence of occult cancer in patients with deep venous thrombosis: a prospective study. J Intern Med. 1996 Feb;239(2):153-6. doi: 10.1046/j.1365-2796.1996.426000.x.
- Background: PubMed 1560799Carson JL, Kelley MA, Duff A, Weg JG, Fulkerson WJ, Palevsky HI, Schwartz JS, Thompson BT, Popovich J Jr, Hobbins TE, et al. The clinical course of pulmonary embolism. N Engl J Med. 1992 May 7;326(19):1240-5. doi: 10.1056/NEJM199205073261902.
- Background: PubMed 3675090Griffin MR, Stanson AW, Brown ML, Hauser MF, O'Fallon WM, Anderson HM, Kazmier FJ, Melton LJ 3rd. Deep venous thrombosis and pulmonary embolism. Risk of subsequent malignant neoplasms. Arch Intern Med. 1987 Nov;147(11):1907-11.
- Background: PubMed 3813741Goldberg RJ, Seneff M, Gore JM, Anderson FA Jr, Greene HL, Wheeler HB, Dalen JE. Occult malignant neoplasm in patients with deep venous thrombosis. Arch Intern Med. 1987 Feb;147(2):251-3.
- Background: PubMed 3341848Monreal M, Salvador R, Soriano V, Sabria M. Cancer and deep venous thrombosis. Arch Intern Med. 1988 Feb;148(2):485. No abstract available.
- Background: PubMed 7073147Gore JM, Appelbaum JS, Greene HL, Dexter L, Dalen JE. Occult cancer in patients with acute pulmonary embolism. Ann Intern Med. 1982 May;96(5):556-60. doi: 10.7326/0003-4819-96-5-556.
- Background: PubMed 1985747Monreal M, Lafoz E, Casals A, Inaraja L, Montserrat E, Callejas JM, Martorell A. Occult cancer in patients with deep venous thrombosis. A systematic approach. Cancer. 1991 Jan 15;67(2):541-5. doi: 10.1002/1097-0142(19910115)67:23.0.co;2-j.
- Background: PubMed 3955523Aderka D, Brown A, Zelikovski A, Pinkhas J. Idiopathic deep vein thrombosis in an apparently healthy patient as a premonitory sign of occult cancer. Cancer. 1986 May 1;57(9):1846-9. doi: 10.1002/1097-0142(19860501)57:93.0.co;2-3.
- Background: PubMed 9655309Hettiarachchi RJ, Lok J, Prins MH, Buller HR, Prandoni P. Undiagnosed malignancy in patients with deep vein thrombosis: incidence, risk indicators, and diagnosis. Cancer. 1998 Jul 1;83(1):180-5. doi: 10.1002/(sici)1097-0142(19980701)83:13.0.co;2-s.
- Background: PubMed 9408011Monreal M, Fernandez-Llamazares J, Perandreu J, Urrutia A, Sahuquillo JC, Contel E. Occult cancer in patients with venous thromboembolism: which patients, which cancers. Thromb Haemost. 1997 Nov;78(5):1316-8.
- Background: PubMed 9459315Rajan 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.
- Background: PubMed 9198140Prins 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Martin MB Otten, MD PhD principal investigator
Slotervaart hospital and Academic Medical Center
Harry R Büller, Md PhD study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Martin H Prins, MD PhD study chair
Maastricht Universitair Medisch Centrum
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Malignancy, run by Slotervaart Hospital at 10 sites in Netherlands.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. 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 was stopped early (reason given: Terminated because of futility to continue, after planned interim analysis.). Results are not available in the source record.
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?
Mortality (time frame: at 3, 6, 12, 24, 36 months after inclusion and at the end of study). 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 NCT01088334, which also lists 38 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 29 Mar 2010.