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

NCT00925808 | Unknown

• 1 other identifier: 2009-0026
• Study Type: observational
• Target: 1,187
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study with the following objectives: Primary Objective:

1. 1.To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT scans of the thorax, abdomen and pelvis.
2. 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. 3.To identify the risk factors and demographic characteristics in outpatient cancer patients associated with the development of unsuspected VTE.
4. 4.To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at 3 and 6 months of follow-up.

Conditions

Cancer; Venous Thromboembolism

Keywords

Unsuspected Venous Thromboembolism; VTE; Routine Computed Tomography; CT Scans

Outcome Measures

Primary Outcomes (1)

• Prevalence of Unsuspected Venous Thromboembolism (VTE) Rate

  Day of enrollment, 3 months (+/- 7 days) and 6 months (+/- 7 days) from study enrollment and during 3 and 6 months follow-up

Study Arms (1)

Unsuspected VTE

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

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

Survey tools and VTE Symptom Follow-up Questionnaire

Unsuspected VTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who have a clinically suspected VTE and/or scheduled for CT scans for suspected VTE.
• Patients not willing to complete survey tools.
• Prior history of PE or DVT.
• Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status score of 4.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carmen Escalante, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

US (1)