Aplastic AnemiaMCSAANCT03208647
Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia
An observational study of Aplastic Anemia, run by Shengyun Lin.
Trial summary
To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially the comprehensive multiple factors risks. The author conducted a case-control research included 338 AA cases and 1464 controls. Read more about this study
- Who is it for?
- Ages 1 year to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- AA or not
- How many people
- 1,802 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 1 Jan 2014
- 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 1 year to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; All cases had no history of tumor and radiation and chemotherapy, without receiving the immunological therapy; the control group cases without hematological diseases, autoimmune diseases, Fanconi anemia, congenital diseases, etc.
Who may be able to join
- All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery;
- 1-65 years old, male or female;
- Sign the informed consent.
Who cannot join
- With myelodysplastic syndrome, leukaemia, multiple myeloma,megaloblastic anaemia, paroxysmal sleep hemoglobinuria disease blood disease, etc.
- History of tumor, radiation or chemotherapy, once accept the immunological therapy, autoimmune diseases or allergic disease patients;
- Patients with neurological diseases.
About this study
Official title: Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia Based on EDC Data Management Platform
To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially the comprehensive multiple factors risks. The author conducted a case-control research included 338 AA cases and 1464 controls. Subjects were surveyed using same standard questionnaire including personal data, past histories of diseases, family history and histories of occupational and daily exposure to harmful substances. Single and multiple Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors in the development of AA.
- Conditions
- Aplastic Anemia
- Being tested
- AA or not
- Keywords
- case-control study, Multiple risk factors
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA or notOther
to study their risk factors
| Study group | Role | What they receive |
|---|---|---|
| AA Group | All the patients of AA group met a AA diagnostic criteria； Receives: Other: AA or not | |
| Control Group | The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; |
What is being measured
The primary outcome is the main question the study is designed to answer.
the items about daily Exposures
Whether living or working near chemical factory or ionizing radiation, whether living in newly decorated apartments/house, having pets/livestock
Measured: January 2014
Secondary outcomes (4)
Individual Behaviours
Smoking (daily number of cigarettes )
Measured: January 2014
Occupational Exposures
the duration of exposure to harmful substance(including industrial glue）
Measured: January 2014
Individual Health Status
the time for the first onset of AA
Measured: January 2014
Family disease history
Whether having the same disease, other blood diseases, malignant tumor
Measured: January 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Jan 2003
- Primary completion1 Jan 2014
- Study completion1 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengyun Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shengyun Lin, Zhejiang Provincial Hospital of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208647
- Sponsor's protocol ID
- MCS-EDC-1802
- Acronym
- MCSAA
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2016
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia Based on EDC Data Management Platform
- ClinicalTrials.gov ID
- NCT03208647
- Acronym / sponsor ID
- MCSAA / MCS-EDC-1802
- Conditions
- Aplastic Anemia
- Keywords
- case-control study, Multiple risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,802 participants (actual)
- Lead sponsor
- Shengyun LinUniversity, hospital or other
- Study start
- 1 Jan 2003
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 1 Jan 2014 (actual)
- First posted
- 5 Jul 2017 (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.
To ascertain the risk factors of AA in ZheJiang Province of China at the moment, especially the comprehensive multiple factors risks. The author conducted a case-control research included 338 AA cases and 1464 controls. Subjects were surveyed using same standard questionnaire including personal data, past histories of diseases, family history and histories of occupational and daily exposure to harmful substances. Single and multiple Logistic regression analyses were made using SPSS17.0 on the dates to study potential factors in the development of AA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA Group | – | Other: AA or notAll the patients of AA group met a AA diagnostic criteria； |
| Control Group | – | –The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; All cases had no history of tumor and radiation and chemotherapy, without receiving the immunological therapy; the control group cases without hematological diseases, autoimmune diseases, Fanconi anemia, congenital diseases, etc.
Key inclusion criteria (3 listed)
- All the patients of AA group met a AA diagnostic criteria；The control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery;
- 1-65 years old, male or female;
- Sign the informed consent.
Key exclusion criteria (3 listed)
- With myelodysplastic syndrome, leukaemia, multiple myeloma,megaloblastic anaemia, paroxysmal sleep hemoglobinuria disease blood disease, etc.
- History of tumor, radiation or chemotherapy, once accept the immunological therapy, autoimmune diseases or allergic disease patients;
- Patients with neurological diseases.
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 |
|---|---|---|
| AA or notto study their risk factors | Other | AA Group |
Primary outcome
the items about daily Exposures
Time frame: January 2014
Whether living or working near chemical factory or ionizing radiation, whether living in newly decorated apartments/house, having pets/livestock
4 secondary outcomes
Individual Behaviours
Time frame: January 2014
Occupational Exposures
Time frame: January 2014
Individual Health Status
Time frame: January 2014
Family disease history
Time frame: January 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aplastic Anemia, run by Shengyun Lin.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the items about daily Exposures (time frame: January 2014). 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 5 Jul 2017.