Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis
Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis
1 other identifier
observational
400
1 country
44
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedStudy Start
First participant enrolled
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedAugust 26, 2022
August 1, 2022
7.4 years
May 29, 2018
August 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OS
Overall survival (OS). From the date of diagnosis to the date of last observation or death from any cause
June 2018-December 2025 (7.5 years)
Secondary Outcomes (3)
PFS
June 2018-December 2025 (7.5 years)
FFS
June 2018-December 2025 (7.5 years)
Response initial therapy
June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)
Study Arms (1)
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
Interventions
Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of classical Hodgkin Lymphoma
- Age ≥ 65 year
- Evaluation of Comprehensive Geriatric Assessment at baseline
- Signed informed consent
- Previously untreated patients
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
SC Ematologia AO SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
Università Politecnica delle Marche - Clinica di Ematologia
Ancona, Italy
Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
Aviano, Italy
AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
Bari, Italy
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Ospedale Businco - Ematologia
Cagliari, Italy
Università Cattolica del Sacro Cuore - Ematologia
Campobasso, Italy
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, Italy
Azienda Ospedaliera di Cosenza - UOC Ematologia
Cosenza, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
UOC Ematologia PO Spaziani
Frosinone, Italy
Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia
Ivrea, Italy
Ospedale Madonna delle Grazie - Ematologia
Matera, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
Meldola, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan, Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan, Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia
Milan, Italy
AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
Napoli, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, Italy
AOU di Padova - Ematologia
Padua, Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padua, Italy
AOU Policlinico Giaccone - Ematologia
Palermo, Italy
AOU di Parma - UO Ematologia e CTMO
Parma, Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, Italy
Ospedale S. Maria della Misericordia - Ematologia
Perugia, Italy
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza, Italy
Ospedale delle Croci - Ematologia
Ravenna, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, Italy
AO Sant'Andrea - Ematologia
Roma, Italy
Ospedale S. Camillo - Ematologia
Roma, Italy
Università Cattolica S. Cuore - Ematologia
Roma, Italy
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, Italy
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, Italy
AOU Senese - U.O.C. Ematologia
Siena, Italy
Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio
Sondrio, Italy
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
Ospedale Ca Foncello - S.C di Ematologia
Treviso, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase, Italy
Biospecimen
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
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Vittorio Ruggero Zilioli, MD
SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 11, 2018
Study Start
August 10, 2018
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
August 26, 2022
Record last verified: 2022-08