Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00809575
Other study ID # QOL-MDS0108
Secondary ID GIMEMA-QOL-MDS-0
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2, 2008
Est. completion date February 2021

Study information

Verified date December 2020
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment. PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.


Description:

This study will ultimately aim at providing the scientific community with additional patient-reported health status data to support and further facilitate the clinical decision-making process. This project has thus a number of goals. The main objective of the protocol is to improve our understanding of the possible added prognostic value of patients' judgment on their own health status and its potential clinical implications. This would aim at providing clinicians with an easy and brief to administer patient-reported health status scale or tool to be used to make more informed treatment decisions. In addition, along with other recent evidence (also looking at the prognostic value of patients' health status judgment in MDS patients), the data of this research could possibly serve to devise a patient-based prognostic index to be used in this higher risk population.


Other known NCT identifiers
  • NCT00872768

Recruitment information / eligibility

Status Active, not recruiting
Enrollment 927
Est. completion date February 2021
Est. primary completion date October 8, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Patients with newly diagnosed myelodysplastic syndrome (MDS) according to WHO classification with any known IPSS risk score category. The initial diagnosis of MDS is acceptable within 3 months before date of registration. - Having a full baseline QoL Evaluation completed (i.e. EORTC QLQ-C30; EQ5D; FACIT-Fatigue and Control Preference Scale). - Adult patients (= 18 years old). - Written informed consent provided. Exclusion criteria - Patients who have received prior treatment other than platelets or RBC transfusions, iron chelation, antibiotic/virostatic drugs, vitamins; - Patients with therapy related MDS. - Having any kind of psychiatric disorder or major cognitive dysfunction. - Not able to read and understand local language.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire administration

fatigue assessment and management

observation

quality-of-life assessment


Locations

Country Name City State
Austria Innsbruck University Hospital Innsbruck
Belgium ZNA Middelheim Antwerpen
Belgium AZ Sint-Jan AV, Department of Hematology Brugge
Belgium CH Jolimont Bruxelles
Belgium CHC - Centre Hospitalier Chrétien Liege
Brazil Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR) Curitiba
China Affiliated Hospital of Liaoning University of Traditional Chinese Medicine China
China Kunming Medical University Kunming
Croatia Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka Rijeka
Czechia General Teaching Hospital Prague
France Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie Saint-Cloud
France Purpan Hospital - Internal Medicine Department Toulouse
Germany Department of Hematology - Universitatsklinikum Carl Gustav Carus Dresden
Germany University of Freiburg Medical Center Freiburg
Italy Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia Asti
Italy Unità Operativa Ematologia 1 - Università degli Studi di Bari Bari
Italy ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo Cagliari
Italy CTMO - Ematologia - Ospedale "Binaghi" Cagliari
Italy Ospedale "Ferrarotto" Catania
Italy A.O. Pugliese Ciaccio Catanzaro
Italy Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione Cona
Italy Aou Careggi - Firenze - Sod Ematologia Firenze
Italy Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino"" Genova
Italy U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea Ivrea Torino
Italy Divisione di Ematologia Ospedale "Santa Maria Goretti" Latina
Italy ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia Lecce
Italy Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST Meldola
Italy Ospedale Niguarda "Ca Granda" Milano
Italy U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele Milano
Italy UO Ematologia - AOU Policlinico di Modena Modena
Italy Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta Monza
Italy S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Novara
Italy Ospedale S. Luigi Gonzaga Orbassano
Italy Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo Parma
Italy Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo Pavia
Italy Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti Piacenza
Italy Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia Reggio Emilia
Italy Complesso Ospedaliero S. Giovanni Addolorata Roma
Italy Divisione Ematologia - Università Campus Bio-Medico Roma
Italy Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Roma
Italy Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Roma
Italy Università degli Studi - Policlinico di Tor Vergata Roma
Italy U.O.C. Ematologia - Ospedale S.Eugenio Rome
Italy SOS Dipartimento di Oncoematologia Osp. Rovigo Rovigo
Italy Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia
Italy Ematologia - Dipartimento di Medicina Clinica e Sperimentale Sassari
Italy Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette Torino
Taiwan National Taiwan University Taipei
United Kingdom Bradford Institute of Health Research Bradford
United Kingdom St James's University Hospital Leeds
United Kingdom London North West Healthcare NHS Trust London
United States The University of Texas, MD Anderson Cancer Center Houston Texas
United States Memorial Sloan-Kettering Cancer Center (MSKCC) New York New York

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  China,  Croatia,  Czechia,  France,  Germany,  Italy,  Taiwan,  United Kingdom, 

References & Publications (6)

Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lübbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12. — View Citation

Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12. — View Citation

Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21. — View Citation

Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lübbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1. — View Citation

Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21. — View Citation

Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the prognostic value of baseline patients' reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients. After 5 years from study entry.
Secondary To investigate the prognostic value of changes overtime of QoL and symptoms for clinical outcomes. i.e. overall survival, AML transformation, toxicity and response to therapy. After 5 years from study entry.
Secondary To describe prospectively short and long-term symptom burden and QoL outcomes by risk group and by type of therapy. After 5 years from study entry.
Secondary To compare the QoL of lower risk patients who maintain stable disease versus those who have progressed to AML or higher-risk score categories. After 5 years from study entry.
Secondary To compare the QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. After 5 years from study entry.
Secondary To establish international QoL and symptoms baseline reference data to be used as benchmarks for comparisons in clinical trials. After 5 years from study entry.
Secondary To evaluate the impact of transfusion dependency at baseline and over time on survival and QoL outcomes. After 5 years from study entry.
Secondary To devise a prognostic patient-based index. After 5 years from study entry.
Secondary To evaluate accuracy of clinical prediction of survival. After 5 years from study entry.
Secondary To assess patients' preferences for involvement in treatment decision-making across different risk group and examine relationships between preferences and patient characteristics. After 5 years from study entry.
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Terminated NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Phase 3
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Recruiting NCT04701229 - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended NCT04485065 - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS Phase 1
Recruiting NCT04174547 - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Completed NCT02508870 - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes Phase 1
Completed NCT04543305 - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies Phase 1
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Recruiting NCT05365035 - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Phase 2
Recruiting NCT06008405 - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1