Ischemic Stroke, AcuteNCT05553990
Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of AIS With Active Cancer
An observational study of Ischemic Stroke, Acute and Tumor Progression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Acute, Tumor Progression
- What is being tested?
- intestinal flora disturbance
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2020to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Acute ischemic stroke with active tumor
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong
jia yin, 13802964883, jiajiayin@139.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute, Tumor Progression
- Being tested
- intestinal flora disturbance
- Medical subject headings
- Ischemic Stroke, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal flora disturbanceOther
To observe the clinical prognosis of stroke patients complicated with tumor after enterobacterial disorder
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke with active tumor | Acute ischemic stroke with active tumor Receives: Other: intestinal flora disturbance | |
| Acute ischemic stroke without active tumor | Acute ischemic stroke without active tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after onset
Mortality
Mortality
Measured: 3 months after onset
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Seventh day of hospitalization、3 months and 6 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start7 Jun 2020
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JIA YIN, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553990
- Sponsor's protocol ID
- NFEC-2022-169
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Human Microbiome and Serological Markers for Clinical Outcome of Acute Ischemic Stroke With Active Cancer
- ClinicalTrials.gov ID
- NCT05553990
- Acronym / sponsor ID
- NFEC-2022-169
- Conditions
- Ischemic Stroke, Acute, Tumor Progression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke with active tumor | – | Other: intestinal flora disturbanceAcute ischemic stroke with active tumor |
| Acute ischemic stroke without active tumor | – | –Acute ischemic stroke without active tumor |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke with active tumor
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intestinal flora disturbanceTo observe the clinical prognosis of stroke patients complicated with tumor after enterobacterial disorder | Other | Acute ischemic stroke with active tumor |
Primary outcome
Neurological function score (mRS score)
Time frame: 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
Mortality
Time frame: 3 months after onset
Mortality
4 secondary outcomes
National Institutes of Health Stroke Scale score(NIHSS score)
Time frame: The first and seventh days of hospitalization、3 months, 6 months and 12 months after onset
Barthel Index
Time frame: 3 months, 6 months and 12 months after onset
Mini-mental State Examination
Time frame: Seventh day of hospitalization、3 months and 6 months after onset
Montreal Cognitive Assessment
Time frame: Seventh day of hospitalization、3 months and 6 months after onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIA YIN study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute and Tumor Progression, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIA YIN (13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological function score (mRS score) (time frame: 3 months after onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.