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Status unknownNCT00925808Updated Aug 30, 2019

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

An observational study in Cancer and Venous Thromboembolism, sponsored by M.D. Anderson Cancer Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by M.D. Anderson Cancer Center · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,187
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Cancer
  • Venous Thromboembolism

Keywords

  • Unsuspected Venous Thromboembolism
  • VTE
  • Routine Computed Tomography
  • CT Scans
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's planned enrollment of 1,187 is above the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,187 participants (estimated)

Groups and cohorts

  • Unsuspected VTE

    Prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis

    Behavioral: Questionnaires

Interventions

  • BehavioralQuestionnaires

    Survey tools and VTE Symptom Follow-up Questionnaire

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00925808
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jun 22, 2009
Start date
Jun 2009
Primary completion
Jun 2020 (estimated)
Completion
Jun 2021 (estimated)
Last update
Aug 30, 2019

Study contacts

Carmen Escalante, MD
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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