Aspergillus PCR Early Detection in High Risk Oncohematological Patients (PCRAGA)

March 16, 2022 updated by: Grupo Espanol de trasplantes hematopoyeticos y terapia celular

ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

ADVANCE THERAPY ASPERGILLOSIS INVASIVE BY PCR DETECTION

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

ADVANCE THERAPY ASPERGILLOSIS INVASIVE IN PATIENTS HIGH RISK ONCOHEMATOLOGICAL PCR USING FOR EARLY DETECTION OF ASPERGILLUS

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario de A Coruña
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall D´Hebron
      • Girona, Spain, 17007
        • Hospital Josep Trueta
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Murcia, Spain, 30008
        • Hospital Morales Meseguer
      • Oviedo, Spain, 33006
        • Hospital Central de Asturias
      • Salamanca, Spain, 37007
        • Hospital Universitario De Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen Del Rocio
      • Valencia, Spain, 46010
        • Hospital Clínico de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Clinico Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trías i Pujol

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will consist of hematological patients at high risk of invasive fungal infection. Like: Leukemia acute mieloblasticas, myelodysplastic syndrome, patients with intensive chemotherapy and allogeneic hematopoietic transplantation.

Description

Inclusion Criteria:

  • Signature of informed consent to participate in the study.
  • Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease.
  • The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section.

Exclusion Criteria:

  • Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation).
  • Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively.
  • Background of IFI proven / probable prior
  • Probable IFI / tested at the time of inclusion in the study.
  • Exclusion will cause a lack of compliance with the inclusion criteria.
  • Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to include the patient in the study.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
High Risk Oncohematological Patients
Detection Aspergillus PCR technique and Aspergillus AGA technique
Procedure: Aspergillus PCR technique
Aspergillus DNA PCR technique
Procedure: Aspergillus AGA technique
Aspergillus AGA technique

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of PCR technique for detection of Aspergillus DNA versus the standard technique for the determination of galactomannan Antigen (AGA) in serum
Time Frame: 18-20 months
To value the percentage of patients with likely/proven invasive fungal infection, diagnosed using only AGA tecnique or using AGA and PCR tecniques together.
18-20 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lourdes Vazquez, MD, University of Salamanca
  • Principal Investigator: Isabel Ruiz, Md, Hospital Vall D´Hebron
  • Principal Investigator: Rocio Parody, MD, Hospital Virgen Del Rocio
  • Principal Investigator: Javier Lopez, MD, Hospital Ramon y Cajal
  • Principal Investigator: Montserrat Rovira, MD, Hospital Clinic of Barcelona
  • Principal Investigator: Montserrat Batlle, MD, Germans Trias i Pujol Hospital
  • Principal Investigator: Carlos Vallejo, MD, Hospital Central de Asturias
  • Principal Investigator: Rosario Varela, MD, Hospital de A Coruña
  • Principal Investigator: Inmaculada Heras, MD, Hospital Morales Meseguer
  • Principal Investigator: Joaquin Diaz, MD, Hospital Clinico San Carlos
  • Principal Investigator: Carlos Solano, MD, Hospital Clínico de Valencia
  • Principal Investigator: Maria Teresa Olave, MD, Hospital Lozano Blesa
  • Principal Investigator: David Gallardo, MD, H. Josep Trueta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETH-PCRAGA

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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