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

Aplastic Anemia Clinical Trial

— MCSAA  

Official title:

Multi Center Case Control Study on Multiple Risk Factors of Aplastic Anemia Based on EDC Data Management Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208647
• Other study ID #: MCS-EDC-1802
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 3, 2017
• Start date: January 1, 2003
• Est. completion date: January 1, 2014

Study information

• Verified date: July 2017
• Source: Zhejiang Provincial Hospital of TCM
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1802
• Est. completion date: January 1, 2014
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia

Intervention

Other:
• AA or not
to study their risk factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shengyun Lin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	January 2014
Secondary	Individual Behaviours	Smoking (daily number of cigarettes )	January 2014
Secondary	Occupational Exposures	the duration of exposure to harmful substance(including industrial glue)	January 2014
Secondary	Individual Health Status	the time for the first onset of AA	January 2014
Secondary	Family disease history	Whether having the same disease, other blood diseases, malignant tumor	January 2014