ThromboembolismNCT00096590
Detecting Abnormal Blood Clotting in Patients With Metastatic Cancer Undergoing Surgery
An observational study of Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery. PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- coagulation study, immunoenzyme technique and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients meeting the following criteria:
- Diagnosis of metastatic carcinoma
- Must be enrolled in 1 of the following surgical protocols:
- NCI-99-C-0123
- NCI-00-C-0069
- NCI-03-C-0085
- NCI-03-C-0212
- Healthy control participant* meeting the following criteria:
- No anemia or thrombocytopenia
- No history of venous thromboembolism (deep vein thrombosis, pulmonary emboli)
- No history of coronary artery disease or stroke
- No chronic inflammatory disease
- No diabetes mellitus
- Have not smoked tobacco within the past 6 months NOTE: * Selected on the basis of gender and age to match the patients as they are accrued
PATIENT CHARACTERISTICS:
- No symptomatic infections or other acute illness within the past 14 days
PRIOR CONCURRENT THERAPY:
- At least 3 days since prior drugs known to inhibit platelet function
- At least 7 days since prior acetylsalicylic acid
- No concurrent estrogen contraceptives or hormone replacement therapy
- No concurrent anticoagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study
RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery.
PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether whole blood thrombin generation assay (WBTGA) detects hypercoagulability in patients with metastatic carcinoma compared with a healthy control group.
- Determine whether results of the WBTGA will change as a result of major surgery performed on patients with metastatic carcinoma.
- Establish a reference interval for the WBTGA using healthy controls.
Secondary
- Compare a battery of plasma components known to affect or reflect coagulant or fibrinolytic reactions in patients with metastatic carcinoma vs healthy controls.
- Establish reference intervals for this battery of tests using healthy controls.
- Determine how major surgery in cancer patients affects this battery of factors.
- Identify changes in these factors that correlate with changes in the WBTGA.
- Compare the results of WBTGA tests in patients who develop venous thromboembolism (VTE) with those who do not.
OUTLINE: This is a pilot study.
Blood samples of patients are collected on day -7 and day 1 after surgery.
Blood samples of healthy controls are collected once.
After collection, blood samples are analyzed for hypercoagulability by whole blood thrombin generation assay. Routine blood tests are performed, as are immunoenzyme techniques for antigenic tissue plasminogen activator and its inhibitor, thrombin-antithrombin complexes, tissue factor, factor VIIa, D-dimer, and glycocalicin.
PROJECTED ACCRUAL: A total of 30 patients and 30 healthy controls will be accrued for this study.
- Being tested
- coagulation study, immunoenzyme technique, laboratory biomarker analysis, physiologic testing, study of high risk factors
- Keywords
- thromboembolism, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulation studyOther
immunoenzyme techniqueOther
laboratory biomarker analysisOther
physiologic testingOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypercoagulability
Secondary outcomes (1)
Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2004 (estimated)
- Study startNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- McDonald K. Horne, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096590
- Sponsor's protocol ID
- CDR0000440092
- Other IDs
- NCI-05-CC-0033
- Status last verified
- Jun 2007
- First submitted
- 11 Nov 2004
- Last updated
- 12 May 2009
- Results posted
- No
Publications
Horne MK 3rd, Merryman PK, Cullinane AM, Nghiem K, Alexander HR. The impact of major surgery on blood coagulation factors and thrombin generation. Am J Hematol. 2007 Sep;82(9):815-20. doi: 10.1002/ajh.20963.
PubMed 17570509
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Blood Test Hypercoagulability in Surgical Patients With Metastatic Carcinoma: A Pilot Study
- ClinicalTrials.gov ID
- NCT00096590
- Acronym / sponsor ID
- CDR0000440092
- Keywords
- thromboembolism, unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2004
- First posted
- 12 Nov 2004 (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.
RATIONALE: A test that detects abnormal blood clotting in patients with cancer may help doctors plan cancer surgery.
PURPOSE: This laboratory study is looking at a new blood test to detect abnormal clotting in patients with metastatic cancer undergoing surgery.
Detailed description
OBJECTIVES:
Primary
- Determine whether whole blood thrombin generation assay (WBTGA) detects hypercoagulability in patients with metastatic carcinoma compared with a healthy control group.
- Determine whether results of the WBTGA will change as a result of major surgery performed on patients with metastatic carcinoma.
- Establish a reference interval for the WBTGA using healthy controls.
Secondary
- Compare a battery of plasma components known to affect or reflect coagulant or fibrinolytic reactions in patients with metastatic carcinoma vs healthy controls.
- Establish reference intervals for this battery of tests using healthy controls.
- Determine how major surgery in cancer patients affects this battery of factors.
- Identify changes in these factors that correlate with changes in the WBTGA.
- Compare the results of WBTGA tests in patients who develop venous thromboembolism (VTE) with those who do not.
OUTLINE: This is a pilot study.
Blood samples of patients are collected on day -7 and day 1 after surgery.
Blood samples of healthy controls are collected once.
After collection, blood samples are analyzed for hypercoagulability by whole blood thrombin generation assay. Routine blood tests are performed, as are immunoenzyme techniques for antigenic tissue plasminogen activator and its inhibitor, thrombin-antithrombin complexes, tissue factor, factor VIIa, D-dimer, and glycocalicin.
PROJECTED ACCRUAL: A total of 30 patients and 30 healthy controls will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| coagulation study | Other | – |
| immunoenzyme technique | Other | – |
| laboratory biomarker analysis | Other | – |
| physiologic testing | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Incidence of hypercoagulability
1 secondary outcome
Comparison of the results of whole blood thrombin generation assay tests in patients who develop venous thromboembolism with those who do not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
- Results publication: PubMed 17570509Horne MK 3rd, Merryman PK, Cullinane AM, Nghiem K, Alexander HR. The impact of major surgery on blood coagulation factors and thrombin generation. Am J Hematol. 2007 Sep;82(9):815-20. doi: 10.1002/ajh.20963.
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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.
McDonald K. Horne, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Incidence of hypercoagulability. 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 NCT00096590, which also lists 1 linked publication.
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 12 May 2009.