Clinical trial NCT03552003: Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis
Official title: Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Classical Hodgkin Lymphoma
Keywords: Hodgkin
Elderly patients
CGA
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

Eligibility 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:

None

Primary outcomes:
measure: OS
timeFrame: June 2018-December 2025 (7.5 years)
Secondary outcomes:
measure: PFS
timeFrame: June 2018-December 2025 (7.5 years)
measure: FFS
timeFrame: June 2018-December 2025 (7.5 years)
measure: Response initial therapy
timeFrame: June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: SC Ematologia AO SS. Antonio e Biagio e C. Arrigo
city: Ancona
country: Italy
facility: Università Politecnica delle Marche - Clinica di Ematologia
city: Avellino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
city: Bari
country: Italy
facility: AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
city: Barletta
country: Italy
facility: Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - Ematologia
city: Cagliari
country: Italy
facility: Ospedale Businco - Ematologia
city: Campobasso
country: Italy
facility: Università Cattolica del Sacro Cuore - Ematologia
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto - Ematologia
city: Cosenza
country: Italy
facility: Azienda Ospedaliera di Cosenza - UOC Ematologia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
city: Frosinone
country: Italy
facility: UOC Ematologia PO Spaziani
city: Ivrea
country: Italy
facility: Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie - Ematologia
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara - SCDU Ematologia
city: Padova
country: Italy
facility: AOU di Padova - Ematologia
city: Padova
country: Italy
facility: I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
city: Palermo
country: Italy
facility: AOU Policlinico Giaccone - Ematologia
city: Parma
country: Italy
facility: AOU di Parma - UO Ematologia e CTMO
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia - Ematologia
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto - U.O. Ematologia
city: Ravenna
country: Italy
facility: Ospedale delle Croci - Ematologia
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
city: Rimini
country: Italy
facility: Ospedale degli Infermi di Rimini - U.O. di Ematologia
city: Roma
country: Italy
facility: AO Sant'Andrea - Ematologia
city: Roma
country: Italy
facility: Ospedale S. Camillo - Ematologia
city: Roma
country: Italy
facility: Università Cattolica S. Cuore - Ematologia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas - U.O. Ematologia
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
city: Siena
country: Italy
facility: AOU Senese - U.O.C. Ematologia
city: Sondrio
country: Italy
facility: Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio
city: Terni
country: Italy
facility: A.O. S. Maria di Terni - S.C. Oncoematologia
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
city: Treviso
country: Italy
facility: Ospedale Ca Foncello - S.C di Ematologia
city: Tricase
country: Italy
facility: A.O. C. Panico - U.O.C Ematologia e Trapianto
Study officials:
affiliation: SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy
name: Vittorio Ruggero Zilioli, MD
role: PRINCIPAL_INVESTIGATOR
References: