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

Ischemic Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553990
• Other study ID #: NFEC-2022-169
• Status: Recruiting
• Start date: June 7, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: September 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: JIA YIN
• Phone: 13802964883
• Email: jiajiayin[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Tumor Progression

Intervention

Other:
• intestinal flora disturbance
To observe the clinical prognosis of stroke patients complicated with tumor after enterobacterial disorder

Locations

Country	Name	City	State
China	Nanfang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mortality	Mortality	3 months after onset
Secondary	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
Secondary	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
Secondary	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
Secondary	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