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Validation of Pathologic Diagnosis of Invasive Fungal Infection by Molecular Method

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ClinicalTrials.gov Identifier: NCT02676570
Recruitment Status : Unknown
Verified February 2016 by Dong-Gun Lee, Seoul St. Mary's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 8, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Dong-Gun Lee, Seoul St. Mary's Hospital

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

Condition or disease
Mycoses

Detailed Description:

This study is a retrospective PCR(polymerase chain reaction) analysis of paraffin-fixed sample with a participants chart review. The PCR analysis will consist of two phases; a PCR test validation phase and an azole resistance test phase. The investigators will also perform a retrospective chart review to investigate the association of participants' fungal clinical outcomes and the presence of azole resistance.

I. PCR analysis

  1. PCR test validation phase

    • Validating PCR assay by mock tissues and Invasive fungal infection proven tissues(microbiologically and pathologically proven cases).
    • The number of validation samples will be 1000 (200 samples * five target PCR).
    • For the enough validation of PCR results, inter-laboratory comparisons, especially with the core laboratory, are performed to verify the PCR results of the same test sample among laboratories and to standardize a certain protocol for the molecular identification of fungal infection from the clinical specimens.
    • Positive controls (human β-globin gene and mouse actin gene) and negative controls (non-infected samples) are used for validating of PCR assays. Precision of each PCR set is checked using the false discovery rate (FDR) which can be the acceptable level of false positives among a set of significant results. If FDR is >5%, it will be rejected.
    • The intra-assay repeatability will be evaluated on 10 replicates of one of the DNA subsamples analyzed in a single assay. The inter-assay reproducibility will be assess on the same DNA subsample five separate times while the inter-sample reproducibility will be determine on separate extractions of the four subsamples amplified a single time. Statistical analysis will be carry out using SAS software.
  2. Azole resistance test phase

    • The investigator will perform a PCR assay using participants biopsied paraffin embedded tissues. Technical method of the PCR assay is attached separately.
    • Around a hundred biopsied samples under impression of fungal infection from June 1st, 2009 to June 31st, 2014 will be included for the PCR testing.

II. Retrospective chart review of all enrolled participants.

  1. Data collection

    • All available participants' electronic medical record data will be reviewed for collecting demographic and clinical information.
  2. Outcome measures

    • The investigators will evaluate Invasive fungal infecrion treatment results, survival rates, and prognosis according to the existence of azole resistance and antifungal treatment modalities including medications.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Validation of Pathologic Diagnosis of Invasive Fungal Infection by Molecular Method - Retrospective Study Using Residual Storage Tissue Specimen
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Identify of fungal species by PCR method [ Time Frame: two years ]
    Identify fungal DNA in Paraffine embedded tissue specimens. The outcome will be describe as success or fail


Secondary Outcome Measures :
  1. Invasive fungal infection treatment success rate [ Time Frame: two years ]
    Evaluate of Invasive fungal infection treatment success rate.


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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02676570


Contacts
Contact: Dong-Gun Lee, M.D., Ph.D. 82-2-2258-6003 symonlee@catholic.ac.kr

Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
Principal Investigator: 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

Responsible Party: Dong-Gun Lee, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02676570     History of Changes
Other Study ID Numbers: KC15SISI0338
IN-US-131-1971 ( Other Identifier: Gilead ISR )
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections