NCT05553990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

4.8 years

First QC Date

September 13, 2022

Last Update Submit

September 18, 2022

Conditions

Ischemic Stroke, AcuteTumor Progression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • Barthel Index

    3 months, 6 months and 12 months after onset

  • Mini-mental State Examination

    Seventh day of hospitalization、3 months and 6 months after onset

  • Montreal Cognitive Assessment

    Seventh day of hospitalization、3 months and 6 months after onset

Study Arms (2)

Acute ischemic stroke with active tumor

Acute ischemic stroke with active tumor

Other: intestinal flora disturbance

Acute ischemic stroke without active tumor

Acute ischemic stroke without active tumor

Interventions

intestinal flora disturbanceOTHER

To observe the clinical prognosis of stroke patients complicated with tumor after enterobacterial disorder

Acute ischemic stroke with active tumor

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute ischemic stroke with active tumor

You may qualify if:

  • : It meets the diagnostic criteria for acute ischemic stroke
  • : Age ≥ 18 years
  • : The onset time is less than or equal to 2 weeks
  • : 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)
  • : Sign an informed consent form, provide relevant medical history information and provide biological specimens

You may not qualify if:

  • : Previous history of disabling stroke (pre-onset mRS ≥2)
  • : Primary central nervous system tumor or hematologic system tumor
  • : The cancer meets the criteria for clinical cure and has not recurred or metastasized for more than 5 years
  • : Antibiotics, prebiotics/probiotics taken within 1 month
  • : Patients who cannot have stool specimens within 4 days of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, oral swabs

MeSH Terms

Conditions

Ischemic StrokeDisease Progression

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • JIA YIN

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

JIA YIN

CONTACT

13802964883jiajiayin@139.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 26, 2022

Study Start

June 7, 2020

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

CN(1)