Clinical trial NCT05553990: Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of AIS With Active Cancer
Official title: Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Acute Ischemic Stroke With Active Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke, Acute
Tumor Progression
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke with active tumor

Brief summary: Explore with active cancer patients with acute ischemic stroke in the human body characteristic microorganism disorder to clinical prognosis of the predictive value of the secondary objective: to observe with active cancer patients with acute ischemic stroke in the body of microorganisms and their serological indexes change law of exploration condition change related biomarkers of microscopic objects group based on the human body.

Detailed description: investigators recently found that changes in gut microbiota in patients with ischemic stroke are associated with the development of disease. However, there are few studies on the correlation between ischemic stroke with cancer and human microbiome and metabolites Whether the human microbiome and its metabolites are associated with the prognosis of such patients remains to be investigated. Therefore, this study hypothesized that structural changes in the human microbiome and its metabolites in patients with acute ischemic stroke with active cancer were associated with stroke severity and disease recovery Therefore, this topic proposed by collecting active follow-up cancer of acute ischemic stroke patients after admission and oral swabs Excrement and urine and blood samples, and based on the queue, follow-up analysis of the human microbiome dynamic change rule and the prognosis of patients with cancer of the acute ischemic stroke correlation, activity, further explore the secondary prevention of stroke management strategy based on the human microbiome.

Eligibility criteria: Inclusion Criteria:

* 1: It meets the diagnostic criteria for acute ischemic stroke

  2: Age ≥ 18 years

  3: The onset time is less than or equal to 2 weeks

  4: Diagnosis of cancer before stroke onset or during hospitalization and active cancer (failure to meet clinical criteria for cure, or discovery of recurrence or metastasis)

  5: Sign an informed consent form, provide relevant medical history information and provide biological specimens

Exclusion Criteria:

* 1: Previous history of disabling stroke (pre-onset mRS ≥2)

  2: Primary central nervous system tumor or hematologic system tumor

  3: The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years

  4: Antibiotics, prebiotics/probiotics taken within 1 month

  5: Patients who cannot have stool specimens within 4 days of admission

Primary outcomes:
measure: Neurological function score (mRS score)
timeFrame: 3 months after onset
measure: Mortality
timeFrame: 3 months after onset
Secondary outcomes:
measure: National Institutes of Health Stroke Scale score(NIHSS score)
timeFrame: The first and seventh days of hospitalization、3 months, 6 months and 12 months after onset
measure: Barthel Index
timeFrame: 3 months, 6 months and 12 months after onset
measure: Mini-mental State Examination
timeFrame: Seventh day of hospitalization、3 months and 6 months after onset
measure: Montreal Cognitive Assessment
timeFrame: Seventh day of hospitalization、3 months and 6 months after onset
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: JIA YIN
role: STUDY_CHAIR
References: