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Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03552003
Recruitment Status : Not yet recruiting
First Posted : June 11, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA)

Condition or disease Intervention/treatment
Classical Hodgkin Lymphoma Other: Treatment for clinical practise

Detailed Description:
The aim of the study is to develop a prognostic index for elderly patients with newly diagnosed cHL starting from a prospective observational study of consecutive cases registered after the completion of the Comprehensive Geriatric Assessment (CGA) Prospective data collection study of a consecutive series of newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study. Patients will be screened and restaged according to clinical practice instrumental and laboratory assessments timing and type of examinations.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Newly diagnosed elderly cHL patients
Newly diagnosed elderly cHL patients undergoing CGA before any therapy (treatment for clinical practise) with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study
Other: Treatment for clinical practise
Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL




Primary Outcome Measures :
  1. OS [ Time Frame: June 2018-December 2025 (7.5 years) ]
    Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause


Secondary Outcome Measures :
  1. PFS [ Time Frame: June 2018-December 2025 (7.5 years) ]
    Progression Free Survival (PFS): From the date of diagnosis to the last follow-up, or to one of the following events: disease progression during treatment, or relapse, or death from any cause.

  2. FFS [ Time Frame: June 2018-December 2025 (7.5 years) ]
    Failure Free Survival (FFS). From the date of diagnosis to to any treatment failure including disease progression, or discontinuation of treatment for any reason, (eg, disease progression, toxicity, patient preference, initiation of new treatment), or death from any cause.

  3. Response initial therapy [ Time Frame: June 2018-January 2024 (5.5 years, 6-7 month after the enrolment) ]
    Response initial therapy: Rate of complete remission (CR) after chemotherapy +/-RT, according to Cheson 2007


Biospecimen Retention:   Samples Without DNA

Mandatory:

1) paraffin block for diagnosis review

Optional:

  1. paraffin block for TISSUE MICRO ARRAYS analyses
  2. 3ml blood adsorbed on a swab tip for IMMUNO SENESCENCE AND FRAILTY evaluation
  3. 3ml blood adsorbed on a swab tip for IMMUNO SENESCENCE AND TORQUE TENO VIRUS evaluation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newly diagnosed elderly cHL patients undergoing CGA before any therapy with the use of ADL, IADL and CIRS-G. Patients who will be considered not eligible to receive treatment or to be given only palliative therapy after CGA assessment are eligible for the study.
Criteria

Inclusion Criteria:

  1. Diagnosis of classical Hodgkin Lymphoma
  2. Age ≥ 65 year
  3. Evaluation of Comprehensive Geriatric Assessment at baseline
  4. Signed informed consent
  5. Previously untreated patients

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552003


Contacts
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Contact: Vittorio Ruggero Zilioli, MD +39 02 64442668 vittorioruggero.zilioli@ospedaleniguarda.it

Locations
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Italy
SC Ematologia AO SS. Antonio e Biagio e C. Arrigo Not yet recruiting
Alessandria, Italy
Contact: Manuela Zanni, MD       manuela.zanni@ospedale.al.it   
Sub-Investigator: Manuela Zanni, MD         
Università Politecnica delle Marche - Clinica di Ematologia Not yet recruiting
Ancona, Italy
Contact: Guido Gini, MD       guido.gini@ospedaliriuniti.marche.it   
Principal Investigator: Guido Gini, MD         
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico Not yet recruiting
Avellino, Italy
Contact: Giuseppe Rodolfo Nunziata, MD       grnunziata@gmail.com   
Principal Investigator: Giuseppe Rodolfo Nunziata, MD         
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A Not yet recruiting
Aviano, Italy
Contact: Michele Spina, MD       mspina@cro.it   
Principal Investigator: Michele Spina, MD         
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto Not yet recruiting
Bari, Italy
Contact: Giorgina Specchia, Prof       giorgina.specchia@uniba.it   
Principal Investigator: Giorgina Specchia, Prof         
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia Not yet recruiting
Barletta, Italy
Contact: Giuseppe Tarantini, MD       giuseppetarantini0@gmail.com   
Principal Investigator: Giuseppe Tarantini, MD         
ASST Spedali Civili di Brescia - Ematologia Not yet recruiting
Brescia, Italy
Contact: Alessandra Tucci, MD       alessandra.tucci@asst-spedalicivili.it   
Principal Investigator: Alessandra Tucci, MD         
Ospedale Businco - Ematologia Not yet recruiting
Cagliari, Italy
Contact: Stefania Massidda, MD       smassidda@email.it   
Principal Investigator: Stefania Massidda, MD         
Università Cattolica del Sacro Cuore - Ematologia Not yet recruiting
Campobasso, Italy
Contact: Sergio Storti, MD       sergio.storti@unicatt.it   
Principal Investigator: Sergio Storti, MD         
Ospedale di Castelfranco Veneto - Ematologia Not yet recruiting
Castelfranco Veneto, Italy
Contact: Roberto Sartori, MD       roberto.sartori@aulss2.veneto.it   
Principal Investigator: Roberto Sartori, MD         
Azienda Ospedaliera di Cosenza - UOC Ematologia Not yet recruiting
Cosenza, Italy
Contact: Massimo Gentile, MD       massimogentile@virgilio.it   
Principal Investigator: Massimo Gentile, MD         
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia Not yet recruiting
Firenze, Italy
Contact: Luigi Rigacci, MD       luigi.rigacci@unifi.it   
Principal Investigator: Luigi Rigacci, MD         
UOC Ematologia PO Spaziani Not yet recruiting
Frosinone, Italy
Contact: Alessandro Andriani, MD       alessandro.andriani1@tin.it   
Principal Investigator: Alessandro Andriani, MD         
Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia Not yet recruiting
Ivrea, Italy
Contact: Roberto Freilone, MD       rfreilone@aslto4.piemonte.it   
Principal Investigator: Roberto Freilone, MD         
Ospedale Madonna delle Grazie - Ematologia Not yet recruiting
Matera, Italy
Contact: Alberto Fragasso, MD       alberto.fragasso@libero.it   
Principal Investigator: Alberto Fragasso, MD         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia Not yet recruiting
Meldola, Italy
Contact: Gerardo Musuraca, MD       g.musuraca@irst.emr.it   
Principal Investigator: Gerardo Musuraca, MD         
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia Not yet recruiting
Milano, Italy
Contact: Vittorio Ruggero Zilioli, MD       vittorioruggero.zilioli@ospedaleniguarda.it   
Principal Investigator: Vittorio Ruggero Zilioli, MD         
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia Not yet recruiting
Milano, Italy
Contact: Andrés Ferreri, MD       andres.ferreri@hsr.it   
Principal Investigator: Andrés Ferreri, MD         
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia Not yet recruiting
Milano, Italy
Contact: Francesca Gaia Rossi, MD       francescagaia.rossi@policlinico.mi.it   
Principal Investigator: Francesca Gaia Rossi, MD         
AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia Not yet recruiting
Napoli, Italy
Contact: Antonello Sica, MD       antonello.sica@fastwebnet.it   
Principal Investigator: Antonello Sica, MD         
AOU Maggiore della Carità di Novara - SCDU Ematologia Not yet recruiting
Novara, Italy
Contact: Luca Nassi, MD       luca.nassi@med.uniupo.it   
Principal Investigator: Luca Nassi, MD         
AOU di Padova - Ematologia Not yet recruiting
Padova, Italy
Contact: Livio Trentin, MD       livio.trentin@unipd.it   
Principal Investigator: Livio Trentin, MD         
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 Not yet recruiting
Padova, Italy
Contact: Dario Marino, MD       dario.marino@iov.veneto.it   
Principal Investigator: Dario Marino, MD         
AOU Policlinico Giaccone - Ematologia Not yet recruiting
Palermo, Italy
Contact: Salvatrice Mancuso, MD       salvatrice.mancuso@unipa.it   
Principal Investigator: Salvatrice Mancuso, MD         
AOU di Parma - UO Ematologia e CTMO Not yet recruiting
Parma, Italy
Contact: Francesca Re, MD       fre@ao.pr.it   
Principal Investigator: Francesca Re, MD         
Ospedale S. Maria della Misericordia - Ematologia Not yet recruiting
Perugia, Italy
Contact: Leonardo Flenghi, MD       flenghi@yahoo.it   
Principal Investigator: Leonardo Flenghi, MD         
Ospedale Guglielmo da Saliceto - U.O. Ematologia Not yet recruiting
Piacenza, Italy
Contact: Annalisa Arcari, MD       a.arcari@ausl.pc.it   
Principal Investigator: Annalisa Arcari, MD         
Ospedale delle Croci - Ematologia Not yet recruiting
Ravenna, Italy
Contact: Monica Tani, MD       monica.tani@auslromagna.it   
Principal Investigator: Monica Tani, MD         
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia Not yet recruiting
Reggio Emilia, Italy
Contact: Francesco Merli, MD       merli.francesco@ausl.re.it   
Principal Investigator: Francesco Merli, MD         
Ospedale degli Infermi di Rimini - U.O. di Ematologia Not yet recruiting
Rimini, Italy
Contact: Anna Lia Molinari, MD       annalia.molinari@auslromagna.it   
Principal Investigator: Anna Lia Molinari, MD         
AO Sant'Andrea - Ematologia Not yet recruiting
Roma, Italy
Contact: Maria Christina Cox, MD       chrisscox@gmail.com   
Principal Investigator: Maria Christina Cox, MD         
Università Cattolica S. Cuore - Ematologia Not yet recruiting
Roma, Italy
Contact: Stefan Hohaus, Prof       stefan.hohaus@Unicatt.it   
Principal Investigator: Stefan Hohaus, MD         
Istituto Clinico Humanitas - U.O. Ematologia Not yet recruiting
Rozzano, Italy
Contact: Francesca Ricci, MD       francesca.ricci@humanitas.it   
Principal Investigator: Francesca Ricci, MD         
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico Not yet recruiting
Sassuolo, Italy
Contact: Sara Bigliardi, MD       s.bigliardi@ospedalesassuolo.it   
Principal Investigator: Sara Bigliardi, MD         
AOU Senese - U.O.C. Ematologia Not yet recruiting
Siena, Italy
Contact: Alberto Fabbri, MD       fabbri7@unisi.it   
Principal Investigator: Alberto Fabbri, MD         
Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio Not yet recruiting
Sondrio, Italy
Contact: Andrea Maria Soccodato, MD       andresocco@alice.it   
Principal Investigator: Andrea Maria Soccodato, MD         
A.O. S. Maria di Terni - S.C. Oncoematologia Not yet recruiting
Terni, Italy
Contact: Anna Marina Liberati, Prof       marina.liberati@unipg.it   
Principal Investigator: Anna Marina Liberati, Prof         
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria Not yet recruiting
Torino, Italy
Contact: Federica Cavallo, MD       f.cavallo@unito.it   
Principal Investigator: Federica Cavallo, MD         
A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia Not yet recruiting
Torino, Italy
Contact: Barbara Botto, MD       bbotto@cittadellasalute.to.it   
Principal Investigator: Barbara Botto, MD         
A.O. C. Panico - U.O.C Ematologia e Trapianto Not yet recruiting
Tricase, Italy
Contact: Vincenzo Pavone, MD       salentoematologia@piafondazionepanico.it   
Principal Investigator: Vincenzo Pavone, MD         
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
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Principal Investigator: Vittorio Ruggero Zilioli, MD SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy

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Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT03552003     History of Changes
Other Study ID Numbers: FIL_ELDHL
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione Italiana Linfomi ONLUS:
Hodgkin
Elderly patients
CGA

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases