MycosesNCT02676570
Validation of Pathologic Diagnosis of Invasive Fungal Infection by Molecular Method
An observational study of Mycoses, run by Seoul St. Mary's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mycoses
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014
Who may be able to join
- Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014
Who cannot join
- Patients who do not currently have residual paraffin-fixed specimens
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of Pathologic Diagnosis of Invasive Fungal Infection by Molecular Method - Retrospective Study Using Residual Storage Tissue Specimen
- Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to distinguish and compare Aspergillus species to the existing optical pathological diagnosis.
- PCR(polymerase chain reaction) validation.
- Compare PCR results, microbial results and treatment results with the medical record.
Read the 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.
- PCR analysis
- 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.
- 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.
- Data collection
- All available participants' electronic medical record data will be reviewed for collecting demographic and clinical information.
- 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.
- Conditions
- Mycoses
- Medical subject headings
- Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify of fungal species by PCR method
Identify fungal DNA in Paraffine embedded tissue specimens. The outcome will be describe as success or fail
Measured: two years
Secondary outcomes (1)
Invasive fungal infection treatment success rate
Evaluate of Invasive fungal infection treatment success rate.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MycosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Gun Lee, Seoul St. Mary's Hospital
- Investigators
- Dong-Gun Lee, M.D., Ph.D., Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676570
- Sponsor's protocol ID
- KC15SISI0338
- Other IDs
- IN-US-131-1971
- Status last verified
- Feb 2016
- First submitted
- 29 Jan 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pathologic Diagnosis of Invasive Fungal Infection by Molecular Method - Retrospective Study Using Residual Storage Tissue Specimen
- ClinicalTrials.gov ID
- NCT02676570
- Acronym / sponsor ID
- KC15SISI0338
- Conditions
- Mycoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Isolate fungal DNA(Deoxyribonucleic acid) from paraffin-fixed tissue specimens to distinguish and compare Aspergillus species to the existing optical pathological diagnosis.
- PCR(polymerase chain reaction) validation.
- Compare PCR results, microbial results and treatment results with the medical record.
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.
- PCR analysis
- 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.
- 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.
- Data collection
- All available participants' electronic medical record data will be reviewed for collecting demographic and clinical information.
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014
Key inclusion criteria (1 listed)
- Patients who were diagnosed with invasive fungal disease based on the biopsy from June 2009 to May 2014
Key exclusion criteria (1 listed)
- Patients who do not currently have residual paraffin-fixed specimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Invasive fungal infection treatment success rate
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Gun Lee, M.D., Ph.D. principal investigator
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
Questions about this trial
What is this clinical trial studying?
An observational study of Mycoses, run by Seoul St. Mary's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Gun Lee, M.D., Ph.D. (82-2-2258-6003, symonlee@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify of fungal species by PCR method (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.