NCT02808858

Brief Summary

Epidemiological data collection of adult patients affected by myelodysplastic syndrome (MDS) newly diagnosed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
73mo left

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2013May 2032

Study Start

First participant enrolled

September 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
15.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Expected
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

May 18, 2016

Last Update Submit

February 27, 2025

Conditions

Keywords

MDSMyelodisplastic Syndrome

Outcome Measures

Primary Outcomes (6)

  • Incidence of MDS diagnosis

    Number of new cases every 100.000 person/year

    6 years

  • Overall Response rate

    Proportion of CR or PR after each line of treatment in term of erythroid, platelet and granulocyte response

    6 years

  • Prevalence of MDS

    Number of cases every 100.000 person

    6 years

  • Overall survival

    Time between MDS diagnosis and death due to any causes

    6 years

  • Progression free survival

    Time between MDS diagnosis and relapse/ progression or death due to any causes

    6 years

  • Progression to AML

    Time between MDS diagnosis and Progression to AML or death due to any causes

    6 years

Eligibility Criteria

Age18 Years - 106 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with new diagnosis of MDS

You may qualify if:

  • New diagnosis of MDS

You may not qualify if:

  • Patient who refuse the signature of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Ematologia, AO SS. Antonio e Biagio

Alessandria, AL, 15121, Italy

RECRUITING

Clinica di Ematologia, AOU Ospedale di Torrette

Ancona, AN, 60020, Italy

RECRUITING

U.O. Clinica Medicina Interna, IRCCS San Martino IST

Genova, GE, 16132, Italy

RECRUITING

Struttura Cattedra di Ematologia e CTMO, AOU di Parma

Parma, PR, 43100, Italy

RECRUITING

Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata

Rionero in Vulture, PZ, 85028, Italy

RECRUITING

FPO - IRCCS di Candiolo

Candiolo, Torino, 10060, Italy

RECRUITING

S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano

Torino, TO, 10128, Italy

RECRUITING

Ospedale Cardinal Massaia

Asti, Italy

RECRUITING

Ematologia AOU Policlinico di Bari

Bari, 70124, Italy

RECRUITING

Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola

Bologna, 40100, Italy

RECRUITING

Ematologia- Ospedale Businco

Cagliari, 09121, Italy

RECRUITING

Ospedale Maggiore

Chieri, Italy

RECRUITING

Cattedra di Ematologia Policlino Careggi

Florence, 50134, Italy

RECRUITING

Dipartimento Emato-Oncologia AOU San Martino Genova

Genova, 16132, Italy

RECRUITING

Medicina interna II Divisione di Ematologia Ospedale S.Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

Azienda Ospedaliera Perugia

Perugia, Italy

RECRUITING

AOU San Salvatore

Pesaro, 61122, Italy

RECRUITING

Ospedale San Giovanbni Battista-Molinette

Torino, Italy

RECRUITING

Divisione di Ematologia-Ospedale Cardinale Panico

Tricase, 73039, Italy

RECRUITING

MeSH Terms

Conditions

Myelodysplastic-Myeloproliferative Diseases

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

June 22, 2016

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion (Estimated)

May 1, 2032

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations