NCT02676570

Brief Summary

  1. 1.Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to distinguish and compare Aspergillus species to the existing optical pathological diagnosis.
  2. 2.PCR(polymerase chain reaction) validation.
  3. 3.Compare PCR results, microbial results and treatment results with the medical record.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

January 29, 2016

Last Update Submit

February 6, 2016

Conditions

Mycoses

Outcome Measures

Primary Outcomes (1)

  • Identify of fungal species by PCR method

    Identify fungal DNA in Paraffine embedded tissue specimens. The outcome will be describe as success or fail

    two years

Secondary Outcomes (1)

  • Invasive fungal infection treatment success rate

    two years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014

You may qualify if:

  • Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014

You may not qualify if:

  • Patients who do not currently have residual paraffin-fixed specimens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Study specimen : Tissue Study content analysis: To determine fungal species and genetic mutations associated with drug resistance by extracting fungal DNA, but not patients' genetic information

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Dong-Gun Lee, M.D., Ph.D.

    Division of Infectious Diseases, Department of Internal Medicine, The Catholic Blood and Marrow Transplantation Center, Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Gun Lee, M.D., Ph.D.

CONTACT

82-2-2258-6003symonlee@catholic.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 9, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share