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

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.

Study Overview

• Status: Completed
• Conditions: Aplastic Anemia
• Intervention / Treatment: Other: AA or not

• Study Type: Observational
• Enrollment (Actual): 1802

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shengyun Lin

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (ACTUAL): July 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: case-control study; Multiple risk factors
• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Bone Marrow Failure Disorders; Anemia; Anemia, Aplastic
• Other Study ID Numbers: MCS-EDC-1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No