MDACC Study Summary 2009-0026

Study Summary
No. 2009-0026:.......Unspecified......Carmen Escalante......General Internal Medicine/Ambulatory Treatment & Emergency Care

Study Summary Title



Study Summary Number:	2009-0026

Study Title:	A Prospective Study of Cancer Patients Diagnosed with Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) scans.

Physician

New Patient Referral



Name:	Carmen Escalante	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	General Internal Medicine/Ambulatory Treatment & Emergency Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-4516 Contact us about clinical trials

General Information



Disease Group:	Unspecified	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Follow up at 3 months (+/- 7 days) and six months (+/- 7 days) from study enrollment.

Treatment Agents:	None	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

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.

Study Status Information



Study Activation / Registration Date:	06/16/2009

IRB Review and Approval Date:	06/16/2009

Study Type:	Observational

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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, daltaparin, warfarin or unfractionated heparin). Patients on heparin flushes for indwelling catheters will not be excluded.

Links

Registration Number: NCT00925808
Study Information on Clinical Trials Registry (clinicaltrials.gov)