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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05553990
Collaborator
(none)
200
1
57.8
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Acute Ischemic Stroke With Active Cancer
Actual Study Start Date :
Jun 7, 2020
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Acute ischemic stroke with active tumor

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

Acute ischemic stroke without active tumor

Outcome Measures

Primary Outcome Measures

  1. Neurological function score (mRS score) [3 months after onset]

    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

  2. Mortality [3 months after onset]

    Mortality

Secondary Outcome Measures

  1. National Institutes of Health Stroke Scale score(NIHSS score) [The first and seventh days of hospitalization、3 months, 6 months and 12 months after onset]

    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

  2. Barthel Index [3 months, 6 months and 12 months after onset]

    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. Mini-mental State Examination [Seventh day of hospitalization、3 months and 6 months after onset]

    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

  4. Montreal Cognitive Assessment [Seventh day of hospitalization、3 months and 6 months after onset]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital,Southern Medical University Guangzhou Guangdong China

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

  • Study Chair: JIA YIN, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT05553990
Other Study ID Numbers:
  • NFEC-2022-169
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022