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Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia (MCSAA)

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ClinicalTrials.gov Identifier: NCT03208647
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Shengyun Lin, Zhejiang Provincial Hospital of TCM

Brief 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. 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.

Condition or disease Intervention/treatment
Aplastic Anemia Other: AA or not

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Study Type : Observational
Actual Enrollment : 1802 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia Based on EDC Data Management Platform
Study Start Date : January 1, 2003
Actual Primary Completion Date : January 1, 2014
Actual Study Completion Date : January 1, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AA Group
All the patients of AA group met a AA diagnostic criteria;
Other: AA or not
to study their risk factors

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;



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Individual Behaviours [ Time Frame: January 2014 ]
    Smoking (daily number of cigarettes )

  2. Occupational Exposures [ Time Frame: January 2014 ]
    the duration of exposure to harmful substance(including industrial glue)

  3. Individual Health Status [ Time Frame: January 2014 ]
    the time for the first onset of AA

  4. Family disease history [ Time Frame: January 2014 ]
    Whether having the same disease, other blood diseases, malignant tumor



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
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Responsible Party: Shengyun Lin, chief, Zhejiang Provincial Hospital of TCM
ClinicalTrials.gov Identifier: NCT03208647    
Other Study ID Numbers: MCS-EDC-1802
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shengyun Lin, Zhejiang Provincial Hospital of TCM:
case-control study
Multiple risk factors
Additional relevant MeSH terms:
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Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases