NCT02231996

Brief Summary

CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine, including clinical feature, laboratory data and genetic information. we aim to find out clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus further improving the level of diagnosis and treatment for CGD.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

1.9 years

First QC Date

August 29, 2014

Last Update Submit

September 3, 2014

Conditions

Granulomatous Disease, Chronic

Outcome Measures

Primary Outcomes (1)

  • times of pneumonia

    2 years

Study Arms (1)

gene mutation

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

CGD patients

You may qualify if:

  • x-linked and AR-linked Chronic Granulomatous Disease
  • history of life-threatening severe infections
  • A functional assay demonstrating abnormal NADPH oxidase function or clinical history consistent with CGD

You may not qualify if:

  • Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Granulomatous Disease, Chronic

Condition Hierarchy (Ancestors)

Phagocyte Bactericidal DysfunctionLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

jing wu

CONTACT

wujingecnu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 4, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2016

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

CN(1)