Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00925808
First received: June 18, 2009
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 Intervention
Cancer
Venous Thromboembolism
Behavioral: Questionnaires

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1187
Study Start Date: June 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925808

Contacts
Contact: Carmen Escalante, MD 713-745-4516

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Carmen Escalante, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Carmen Escalante, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00925808     History of Changes
Other Study ID Numbers: 2009-0026
Study First Received: June 18, 2009
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014