Non-Small Cell Lung CarcinomaNCT00192829
Hypercoagulable Parameters as Predictors of Thrombotic Events and Prognosis in Patients With Advanced Non-Small Cell Lung Carcinoma
An observational study of Non-Small Cell Lung Carcinoma and Venous Thromboembolism, run by Rambam Health Care Campus at 2 sites in Israel.
Trial summary
The association between cancer and thrombosis is well known and the occurrence of thrombotic complications is commonly associated with poor prognosis. The aim os this study is to determine the possible value of hypercoagulable parameters as prognostic parameters in advanced non-small cell lung carcinoma (NSCLC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Carcinoma, Venous Thromboembolism
- What is being tested?
- Blood sample withdrawal
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2005to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of NSCLC.
- normal serum bilirubin
- informed concent to participate in the study
Who cannot join
- anticoagulant therapy
- infectious disease
Trial locations and contacts
2 sites in 1 country.
Nissim Haim, M.D contact
Israel2 sites, 2 recruiting
- Recruiting
Hematology Laboratory
Haifa
Galit Sarig, Ph.D, +972-4-8543523, g_sarig@rambam.health.gov.il
Galit Sarig, Ph.D
- Recruiting
Oncology Institution, Rambam Health Campus
Haifa
Nissim Haim, M.D, n_haim@rambam.health.gov.il
Nissim Haim, M.D
About this study
The association between cancer and thrombosis is well known and the occurrence of thrombotic complications is commonly associated with poor prognosis. The aim os this study is to determine the possible value of hypercoagulable parameters as prognostic parameters in advanced non-small cell lung carcinoma (NSCLC).
- Being tested
- Blood sample withdrawal
- Keywords
- Lung cancer, Thrombosis, Hypercoagulable
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Venous Thromboembolism, Lung Neoplasms, Thrombosis, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample withdrawalProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CarcinomaStudies 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Galit Sarig, Ph.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192829
- Sponsor's protocol ID
- Thrombosis and cancer.CTIL
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 11 Apr 2007
- Results posted
- No
Publications
Haim N, Lanir N, Hoffman R, Haim A, Tsalik M, Brenner B. Acquired activated protein C resistance is common in cancer patients and is associated with venous thromboembolism. Am J Med. 2001 Feb 1;110(2):91-6. doi: 10.1016/s0002-9343(00)00691-4.
PubMed 11165549Blom JW, Osanto S, Rosendaal FR. The risk of a venous thrombotic event in lung cancer patients: higher risk for adenocarcinoma than squamous cell carcinoma. J Thromb Haemost. 2004 Oct;2(10):1760-5. doi: 10.1111/j.1538-7836.2004.00928.x.
PubMed 15456487Ferrigno D, Buccheri G, Ricca I. Prognostic significance of blood coagulation tests in lung cancer. Eur Respir J. 2001 Apr;17(4):667-73. doi: 10.1183/09031936.01.17406670.
PubMed 11401062
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercoagulable Parameters as Predictors of Thrombotic Events and Prognosis in Patients With Advanced Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00192829
- Acronym / sponsor ID
- Thrombosis and cancer.CTIL
- Keywords
- Lung cancer, Thrombosis, Hypercoagulable
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 19 Sep 2005 (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.
The association between cancer and thrombosis is well known and the occurrence of thrombotic complications is commonly associated with poor prognosis. The aim os this study is to determine the possible value of hypercoagulable parameters as prognostic parameters in advanced non-small cell lung carcinoma (NSCLC).
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC.
- normal serum bilirubin
- informed concent to participate in the study
Key exclusion criteria (2 listed)
- anticoagulant therapy
- infectious disease
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 |
|---|---|---|
| Blood sample withdrawal | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
- Background: PubMed 11165549Haim N, Lanir N, Hoffman R, Haim A, Tsalik M, Brenner B. Acquired activated protein C resistance is common in cancer patients and is associated with venous thromboembolism. Am J Med. 2001 Feb 1;110(2):91-6. doi: 10.1016/s0002-9343(00)00691-4.
- Background: PubMed 15456487Blom JW, Osanto S, Rosendaal FR. The risk of a venous thrombotic event in lung cancer patients: higher risk for adenocarcinoma than squamous cell carcinoma. J Thromb Haemost. 2004 Oct;2(10):1760-5. doi: 10.1111/j.1538-7836.2004.00928.x.
- Background: PubMed 11401062Ferrigno D, Buccheri G, Ricca I. Prognostic significance of blood coagulation tests in lung cancer. Eur Respir J. 2001 Apr;17(4):667-73. doi: 10.1183/09031936.01.17406670.
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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.
Nissim Haim, M.D contact
Galit Sarig, Ph.D principal investigator
Rambam Health Care Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Carcinoma and Venous Thromboembolism, run by Rambam Health Care Campus at 2 sites in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galit Sarig, Ph.D (+972-4-8543503, g_sarig@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192829, which also lists 3 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 11 Apr 2007.