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

18 Years
Open (Enrolling)
Cancer, Venous Thromboembolism

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Trial Information

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

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

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.

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Prevalence of Unsuspected VTE (Rate)

Outcome 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

Safety Issue:


Principal Investigator

Carmen Escalante, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2009

Completion Date:

Related Keywords:

  • Cancer
  • Venous Thromboembolism
  • Unsuspected Venous Thromboembolism
  • VTE
  • Routine Computed Tomography
  • CT Scans
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis



UT MD Anderson Cancer Center Houston, Texas  77030