NCT00462657

Brief Summary

RATIONALE: Studying ways to diagnose fungal infections early may help doctors plan the best treatment. PURPOSE: This clinical trial is studying laboratory tests to see how well they find aspergillosis early in patients at high risk of fungal infection caused by treatment for hematologic cancer or other disease.

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
Last Updated

August 26, 2013

Status Verified

September 1, 2007

First QC Date

April 18, 2007

Last Update Submit

August 23, 2013

Conditions

Graft Versus Host DiseaseInfectionLeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

infectionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)adult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionde novo myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesgraft versus host disease

Outcome Measures

Primary Outcomes (2)

  • Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA)

  • Diagnostic value of IA screening by GM ELISA and real time PCR, in terms of positive and negative predicative values

Interventions

polymerase chain reactionGENETIC
bronchoalveolar lavageOTHER
immunoenzyme techniqueOTHER
laboratory biomarker analysisOTHER
bronchoscopyPROCEDURE
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * At high risk for developing invasive aspergillosis (IA) due to any of the following risk factors: * Diagnosis of acute myeloid leukemia, myelodysplastic syndromes, or acute lymphoblastic leukemia AND meets ≥ 1 of the following criteria: * Receiving intensive chemotherapy with expected duration of neutropenia (ANC \< 500/mm³) of \> 10 days * Receiving high-dose steroids * Concurrent treatment with allogeneic hematopoietic stem cell transplantation (HSCT) * Requirement for high-dose steroids for graft-versus-host disease after HSCT * History of probable or proven IA and receiving chemotherapy * No preexisting chest disease PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

RECRUITING

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Graft vs Host DiseaseInfectionsLeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesCongenital AbnormalitiesMyeloproliferative DisordersPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

Polymerase Chain ReactionBronchoalveolar LavageImmunoenzyme TechniquesBronchoscopy

Condition Hierarchy (Ancestors)

Immune System DiseasesNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesTherapeutic IrrigationImmunoassayImmunologic TechniquesImmunohistochemistryMolecular Probe TechniquesDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Samir G Agrawal, MD, PhD

    St. Bartholomew's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 19, 2007

Study Start

July 1, 2005

Last Updated

August 26, 2013

Record last verified: 2007-09

Locations

GB(2)