MDACC Study Summary 2006-1095 (Archived)

Study Summary
No. 2006-1095:.......Hematologic Disorder; Solid Tumors......Amar Safdar......Infectious Disease

Study Summary Title



Study Summary Number:	2006-1095

Study Title:	Latent Mycobacterium tuberculosis Infection among Cancer patients

Physician

New Patient Referral



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

Dept:	Infectious Disease	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0045 Contact us about clinical trials

General Information



Disease Group:	Hematologic Disorder Solid Tumors	Supported By:	Oxford Immunotec Limited

Phase of Study:	N/A	Return Visit:	The participants will come back to MDACC within 48 to 72 hours after the Tuberculin skin test is performed. Total patient return visits: 1 (one). Only applicable for participants enrolled as outpatient basis.

Treatment Agents:	Diagnostic Device T-Spot.TB Test Assay	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Principal investigator will assess possible research subjects among patients already admitted to the hospital to receive any medical, surgical and chemotherapy related care due to underlying disease. Protocol does not require admission to the hospital in any circumstances.


Description/ Intervention:	The goal of this clinical research study is to evaluate the effectiveness and accuracy of the new T-SPOT.TB test in the detection of latent (present but not active) TB infection in patients with cancer.

Study Objectives / Outcomes

Primary objective:

To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant.

Secondary objective:

To examine the factors associated with positive response to T-SPOT.TB and the
TST in patients with anergy.

To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	06/28/2007

Study Type:	Other

Recruitment Status:	Terminated

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) Males and females.

2) Patients who are receiving chemotherapy for hematologic malignancy and solid-organ cancer.

3) Patients with a HSCT history will be included after >1 year of transplantation.

Exclusion Criteria:

1) Refusal of consent

2) Individuals who, on the advice of the Primary or enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration.

3) Lymphocytopenia (< 300 cells/microliter)

4) Patients with known HIV infection.

5) Patients with known active tuberculosis will not be included in this study.

Links

Registration Number: NCT00507754
Study Information on Clinical Trials Registry (clinicaltrials.gov)