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

July 3, 2017 updated by: Shengyun Lin

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengyun Lin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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