Latent Mycobacterium Tuberculosis Infection Among Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate of Positive Results of T-SPOT.TB (%)
研究概览
简要总结
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 Objectives:
- To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) 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.
详细描述
TB AND TB TESTS:
Patients with cancer are considered "immunocompromised." This means that, because of the cancer and the cancer treatment, the immune system does not function normally, which decreases its ability to fight off infection and disease. This immunocompromised condition places these patients (who probably had been in contact with the TB bacteria, resulting in latent, or inactive, TB) at risk for active TB. Latent TB does not cause symptoms or signs of active TB infection. It is very important to identify patients who are at risk for developing active TB, so that they can receive timely treatment for TB.
The Tuberculin skin test (TST) is currently used to detect latent TB. The TST is considered to have low detection sensitivity, which means that it may not always detect latent TB, which may then turn into an active TB infection.
The T-SPOT.TB is a new test that researchers want to study to see whether it may be more effective and accurate than the TST at identifying patients at risk for developing active TB.
STUDY PARTICIPATION:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females.
- •Patients who are receiving chemotherapy for hematologic malignancy and solid-organ cancer.
- •Patients with a Hematopoietic stem cell transplantation (HSCT) history will be included after >1 year of transplantation.
排除标准
- •Refusal of consent
- •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.
- •Lymphocytopenia (< 300 cells/microliter)
- •Patients with known HIV infection.
- •Patients with known active tuberculosis will not be included in this study.
结局指标
主要结局
Rate of Positive Results of T-SPOT.TB (%)
时间窗: Study period 2 Years
Number participants with postitive T-SPOT.TB test results compared to total positive results, derived from Center for Disease Control (CDC) Criteria used for LTBI positive skin test (i.e. a tuberculin skin test (TST) with 5 mm or more of induration). For those individuals with \>5 mm induration on TST, chest radiograph performed. Fisher's exact test used to assess the association between categorical variables and the testing results of T-SPOT.TB or TST.
次要结局
未报告次要终点