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COMPLETED

Patient Reported Outcomes in Chronic Myeloid Leukemia

NCT01252589 · View on ClinicalTrials.gov ↗

Study Summary

Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is lacking in comparison. The literature shows that patients' perspective is unique and should always be measured with methodologically sound instruments that are devised for this purpose. The main scope of this project is develop to an international validated questionnaire for the purpose of HRQOL assessment; such a tool will then be used to provide important data, from the patients' perspective, to make more informed treatment decisions.

Conditions Studied

Interventions

  • OTHER HRQOL questionnaire

Study Locations (14)

Other

  • Innsbruck University Hospital — Innsbruck
  • University of Ghent — Ghent
  • Centre Hospitalier Universitaire of Poitiers — Poitiers
  • University of Heidelberg — Heidelberg
  • University of Athens — Athens
  • University of Baghdad — Baghdad
  • Policlinico S. Orsola - Malpighi, Università di Bologna — Bologna
  • Ematologia Ospedale "Binaghi", Cagliari — Cagliari
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori- IRST — Meldola
  • Ospedale S.Maria delle Croci — Ravenna
  • Ematologia - Sapienza Università di Roma — Roma
  • Tilburg University — Tilburg
  • National Taiwan University — Taipei

Massachusetts

  • Dana-Farber Cancer Institute Harvard University — Boston

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2010-11
Est. Completion 2013-09

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01252589

The ClinicalTrials.gov registry entry for NCT01252589 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gruppo Italiano Malattie EMatologiche dell'Adulto, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention — of which HRQOL questionnaire is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01252589 reports 14 study locations spanning 2 distinct geographic areas — top geographies include Other, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01252589 about?

NCT01252589 is a clinical study titled "Patient Reported Outcomes in Chronic Myeloid Leukemia". Although the impact of disease and treatment related burden on health-related quality of life (HRQOL) in patients with solid tumours has been well studied, with several clinical trials that included HRQOL as an endpoint, the general understanding in patients with Chronic Myeloid Leukaemia (CML) is l...

What is the current status of trial NCT01252589?

This trial is currently completed. The enrollment target is 480 participants. The study started on 2010-11. Estimated completion is 2013-09.

What conditions does trial NCT01252589 study?

This clinical trial studies the following conditions: Chronic Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01252589?

The interventions under investigation include: HRQOL questionnaire (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01252589?

This trial is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01252589 being conducted?

This trial has 14 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial