A 15-year Cohort Study on Risk Factors of Mortality in Patients With Intestinal Tuberculosis
3. Mai 2026 aktualisiert von: Xuelian Li, Beijing Chest Hospital, Capital Medical University
A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis
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 manifestations, laboratory test results, treatment regimens, and follow-up outcomes (mortality status), will be collected and sorted out in both stages.
Univariate and multivariate statistical analyses will be used to screen and verify potential risk factors (such as age, disease severity, comorbidities, and treatment compliance) that affect the mortality of patients with intestinal tuberculosis.
The results of this study are expected to provide scientific evidence for optimizing the clinical management, risk assessment, and prognostic improvement of patients with intestinal tuberculosis, and further guide the formulation of targeted prevention and treatment strategies.
Studienübersicht
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
500
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Xuelian X Li, MD
- Telefonnummer: +86 010-89509321
- E-Mail: lilyxuelian@126.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 101149
- Rekrutierung
- Beijing Chest Hospital
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Kontakt:
- Wenjuan N Nie, MD
- Telefonnummer: +86010-89509321
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
The study population consists of patients diagnosed with intestinal tuberculosis, covering both the retrospective and prospective research stages.
The Retrospective Intestinal Tuberculosis Cohort includes patients diagnosed with intestinal tuberculosis between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status).
The Prospective Intestinal Tuberculosis Cohort includes newly diagnosed intestinal tuberculosis patients who can cooperate with follow-up and provide complete clinical information.
The study population is mainly used to analyze the risk factors related to mortality in intestinal tuberculosis patients, so as to provide a scientific basis for optimizing clinical management and improving the prognosis of patients.
Beschreibung
Inclusion Criteria:
- Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis;
- Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results);
- For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status);
- For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable);
- No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up.
Exclusion Criteria:
- Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis);
- Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes;
- 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);
- 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;
- 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;
- Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Retrospective Intestinal Tuberculosis Cohort
This cohort includes intestinal tuberculosis patients diagnosed and followed up in Beijing Chest Hospital from 2011-01 to 2025-12 (15-year retrospective period).
The research data are collected by reviewing historical medical records, mainly used for initial screening of mortality-related risk factors.
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Beobachtungs
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Prospective Intestinal Tuberculosis Cohort
This cohort includes newly diagnosed intestinal tuberculosis patients enrolled continuously after the retrospective stage.
The research data are collected through dynamic follow-up of the subjects, mainly used for verifying and supplementing the mortality-related risk factors identified in the retrospective cohort.
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Beobachtungs
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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All-cause mortality in patients with intestinal tuberculosis.
Zeitfenster: For the Retrospective Intestinal Tuberculosis Cohort, the time frame is 15 years, from January 2011 to December 2025; for the Prospective Intestinal Tuberculosis Cohort, the time frame is 3 years from the date of the first patient enrollment
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Death of the study subject due to any cause during the study period
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For the Retrospective Intestinal Tuberculosis Cohort, the time frame is 15 years, from January 2011 to December 2025; for the Prospective Intestinal Tuberculosis Cohort, the time frame is 3 years from the date of the first patient enrollment
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Wenjuan Nie, MD, Beijing Chest Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2026
Primärer Abschluss (Geschätzt)
1. Dezember 2026
Studienabschluss (Geschätzt)
1. Dezember 2036
Studienanmeldedaten
Zuerst eingereicht
3. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Mai 2026
Zuerst gepostet (Tatsächlich)
8. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LW-2026-013
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
The shared IPD includes de-identified clinical data of research subjects.
IPD-Sharing-Zeitrahmen
IPD will be made available for sharing after the completion of the study
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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