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Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00925808
Recruitment Status : Active, not recruiting
First Posted : June 22, 2009
Last Update Posted : January 24, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

This is a prospective study with the following objectives:

Primary Objective:

  1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis.

    Secondary Objectives:

  2. To identify symptoms commonly associated with VTE that are present in cancer patients undergoing routine staging CT scans with findings of unsuspected VTE.
  3. To identify the risk factors and demographic characteristics in outpatient cancer patients associated with the development of unsuspected VTE.
  4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at 3 and 6 months of follow-up.

Condition or disease Intervention/treatment
Cancer Venous Thromboembolism Behavioral: Questionnaires

Detailed Description:

Patients diagnosed with cancer are routinely scheduled for staging CT scans. The CT scans are obtained to stage a new cancer diagnosis, to restage a cancer after treatment initiation or to evaluate abnormal masses, disease progression or metastasis. The study population will include outpatients scheduled for routine CT scan of the chest, abdomen and/or pelvis.

While patients are waiting in the Diagnostic Imaging waiting area, they will be invited to participate in the study. Study eligibility will be determined by administering a screening questionnaire. Cancer patients who meet the eligibility criteria will be asked to participate in the study. It is imperative that the patient completes the surveys and not the caregiver. A caregiver may lend assistance in transcribing the information but may not complete the instruments independent of the patient.

Many of these tools are brief and the estimated completion time should be approximately 15 to 30 minutes. Additionally completing the instruments will not extend beyond the time the patient is in the CT scan waiting area prior to the scheduled study.

On the day of study enrollment, patients will be asked to complete Brief Fatigue Inventory (BFI), MD Anderson Symptom Inventory (MDASI), Dyspnea Numerical Scale (DNS), Cancer Dyspnea Scale (CDS), ECOG/Zubrod Performance scale, Depression Anxiety Stress Scale (DASS 21), VTE Symptom Enrollment Questionnaire and Functional Assessment of Cancer Therapy-General (FACT-G). The patients will also complete a questionnaire on symptoms of VTE such as chest pain, pain or swelling of the extremities and other common symptoms reported in VTE patients.

VTE Symptom Follow-up Questionnaire:This instrument was designed for this study. Patients will be asked at 3 and 6 months the treatments received, recurrence of VTE, incidence of bleeding episodes and other health related conditions.

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Study Type : Observational
Estimated Enrollment : 1187 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Study of Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans
Actual Study Start Date : June 2009
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Unsuspected VTE
Prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis
Behavioral: Questionnaires
Survey tools and VTE Symptom Follow-up Questionnaire

Primary Outcome Measures :
  1. Prevalence of Unsuspected Venous Thromboembolism (VTE) Rate [ Time Frame: Day of enrollment, 3 months (+/- 7 days) and 6 months (+/- 7 days) from study enrollment and during 3 and 6 months follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include cancer outpatients, 18 years or older, scheduled for routine CT scan of the chest, abdomen and/or pelvis at UT MD Anderson Cancer Center.

Inclusion Criteria:

  1. Patients with a diagnosis of cancer.
  2. Subjects must be 18 years or more.
  3. Male and female patients are eligible for enrollment.
  4. Patients who are scheduled for routine outpatient cancer staging using CT scans.
  5. Patients must be able to complete the required survey tools independently.
  6. Patients must be able to speak, read and write English.

Exclusion Criteria:

  1. Patients who have a clinically suspected VTE and/or scheduled for CT scans for suspected VTE.
  2. Patients not willing to complete survey tools.
  3. Prior history of PE or DVT.
  4. Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status score of 4.
  5. Patients currently on anticoagulation therapy (low molecular weight heparin, fondaparinux, dalteparin, warfarin or unfractionated heparin). Patients on heparin flushes for indwelling catheters will not be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00925808

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Carmen Escalante, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00925808     History of Changes
Other Study ID Numbers: 2009-0026
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Unsuspected Venous Thromboembolism
Routine Computed Tomography
CT Scans

Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases