Clinical trial · Observational
Latent Tuberculosis Infection in Cancer Patients
Latent Mycobacterium Tuberculosis Infection Among Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: 1\. 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: 1. To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) in patients with anergy. 2. To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-SPOT TB test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Latent Tuberculosis Infection
- description
- Patients with cancer at risk for developing active tuberculosis (TB).
- interventionNames
- Other: T-SPOT TB test
Primary outcomes (1)
- measure
- Rate of Positive Results of T-SPOT.TB (%)
- timeFrame
- Study period 2 Years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available