Skip to main content
OpenTrials
Completed

NCT Number: NCT04153305

European Registry for Myeloproliferative Neoplasms (MPNs) - Update of ERNEST Study

The Fondazione per la Ricerca Ospedale di Bergamo (FROM) decided to propose and promote the completion of ERNEST registry: the aim of the project is to obtain up-to-date estimates of clinical outcome of these patients in primary and secondary Myelofibrosis that have been included in the 'original' ERNEST study. The last was conducted between 2012 and beginning of 2015 including 1292 patients with Myelofibrosis, but it was interrupted in 2015 because of bankruptcy of the previous sponsor.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms, Second Primary Primary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Careggi, Florence, FI, Italy

Loading trial locations.

About this study

Follow-up of patients already been registered in the ERNEST registry resulting alive and/or in active surveillance at November 2014 (Blood 2014 124:1849) will be updated retrospectively until December 2020. Data collection will be centralized at Fondazione per la Ricerca Ospedale di Bergamo (FROM), and performed by a web-based and Electronic Data Capture (EDC) system through ad hoc electronic case report forms (e-CRFs). The e-CRFs system will be pre-filled with pre-existing data collected from cases already entered in the registry. Information on therapies received and outcome events occurred (in term of death, evolution to acute leukemia, secondary cancer and cardiovascular complications) until December 2020 will be recorded by authorized participating investigators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • previous registration in the ERNEST registry (2012 - 2014)
  • diagnosis of MF performed between January 2001 and 2012 December
  • Signed informed consent to continue participation in the registry

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Number of death

    Time frame: 18 years

    Overall Survival

Secondary outcomes

  1. Number of patients with evolution to acute leukemia (AL)

    Time frame: 18 years

    Occurrence of AL from diagnosis to last observation

  2. Number of patients with secondary tumor (ST)

    Time frame: 18 years

    Occurrence of ST from diagnosis to last observation

  3. Number of patients with cardiovascular (CV) complications

    Time frame: 18 years

    Occurrence of events from diagnosis to last observation

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Acronym: ERNEST

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.