Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of AIS With Active Cancer

Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Acute Ischemic Stroke With Active Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke, Acute; Tumor Progression
• Intervention / Treatment: Other: intestinal flora disturbance

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital，Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Acute ischemic stroke with active tumor

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute ischemic stroke with active tumor	Other: intestinal flora disturbance; To observe the clinical prognosis of stroke patients complicated with tumor after enterobacterial disorder
Acute ischemic stroke without active tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological function score (mRS score)	Neurological function score (mRS score) ，The minimum score is 0 and the maximum score is 5，The higher the mRS score, the worse the prognosis	3 months after onset
Mortality	Mortality	3 months after onset

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale score(NIHSS score)	National Institutes of Health Stroke Scale score(NIHSS score) ，The minimum score is 0 and the maximum score is 42，The higher the NIHSS score, the worse the neurological function	The first and seventh days of hospitalization、3 months, 6 months and 12 months after onset
Barthel Index	Barthel Index，The minimum score is 0 and the maximum score is 100，The higher the BI index, the better the ability to take care of yourself	3 months, 6 months and 12 months after onset
Mini-mental State Examination	Mini-mental State Examination，The minimum score is 0 and the maximum score is 30，Closely related to educational attainment, the higher the score, the better the Closely related to educational attainment, the higher the score, the better the Closely related to educational attainment, the higher the score, the better the cognitive function	Seventh day of hospitalization、3 months and 6 months after onset
Montreal Cognitive Assessment	Montreal Cognitive Assessment，The minimum score is 0 and the maximum score is 30，Closely related to educational attainment, the higher the score, the better the cognitive function	Seventh day of hospitalization、3 months and 6 months after onset

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2020
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NFEC-2022-169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No