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A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis

Recruitingn/aAges 18 Years - 100 YearsAllBeijing Chest Hospital, Capital Medical University
NCT07575061 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study adopts a combined design of retrospective cohort study followed by prospective observational study, which is conducted at Beijing Chest Hospital. The study first collects and analyzes the data of intestinal tuberculosis patients diagnosed and followed up in the hospital from 2011-1 to 2025-12 (a 15-year retrospective period) as the retrospective cohort, aiming to initially identify the risk factors associated with mortality in patients with intestinal tuberculosis. On the basis of the retrospective analysis results, the study will further carry out a prospective observational study, continuously enroll new intestinal tuberculosis patients, follow up their clinical status, treatment response and mortality outcomes for a certain period, and verify and supplement the risk factors identified in the retrospective stage. Clinical data, including demographic characteristics, clinical

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis; 2. Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results); 3. For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status); 4. For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable); 5. No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up. Exclusion Criteria: 1. Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis); 2. Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes; 3. For the Retrospective Intestinal Tuberculosis Cohort: patients with incomplete medical records or missing key follow-up data (especially mortality status and related risk factor information); 4. For the Prospective Intestinal Tuberculosis Cohort: patients who refuse to sign the informed consent form (if applicable), cannot cooperate with regular follow-up, or are lost to follow-up during the study period; 5. Patients with severe comorbidities that may lead to rapid death (such as advanced malignant tumors, severe heart failure, end-stage liver/kidney disease) within the study period, which may interfere with the analysis of mortality risk factors related to intestinal tuberculosis; 6. Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.
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What it tests

  • Observational
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Where

1 site
Beijing Chest Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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