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

August 23, 2022 updated by: Fondazione Italiana Linfomi ONLUS

Prospective Study on Elderly (≥ 65 Years) Patients Affected With Classical Hodgkin Lymphoma Undergoing Comprehensive Geriatric Assessment at Diagnosis

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Alessandria, Italy
        • Not yet recruiting
        • SC Ematologia AO SS. Antonio e Biagio e C. Arrigo
        • Contact:
        • Sub-Investigator:
          • Manuela Zanni, MD
      • Ancona, Italy
        • Recruiting
        • Università Politecnica delle Marche - Clinica di Ematologia
        • Principal Investigator:
          • Guido Gini, MD
        • Contact:
      • Avellino, Italy
        • Not yet recruiting
        • Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
        • Contact:
        • Principal Investigator:
          • Giuseppe Rodolfo Nunziata, MD
      • Aviano, Italy
        • Recruiting
        • Centro Riferimento Oncologico - S.O.C. Oncologia Medica A
        • Contact:
      • Bari, Italy
        • Recruiting
        • AOU Policlinico Consorziale - U.O. Ematologia con Trapianto
        • Contact:
        • Principal Investigator:
          • Giorgina Specchia, Prof
      • Barletta, Italy
        • Not yet recruiting
        • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
        • Contact:
      • Brescia, Italy
      • Cagliari, Italy
        • Not yet recruiting
        • Ospedale Businco - Ematologia
        • Contact:
        • Principal Investigator:
          • Stefania Massidda, MD
      • Campobasso, Italy
        • Not yet recruiting
        • Università Cattolica del Sacro Cuore - Ematologia
        • Contact:
        • Principal Investigator:
          • Sergio Storti, MD
      • Castelfranco Veneto, Italy
        • Recruiting
        • Ospedale di Castelfranco Veneto - Ematologia
        • Principal Investigator:
          • Roberto Sartori, MD
        • Contact:
      • Cosenza, Italy
        • Not yet recruiting
        • Azienda Ospedaliera di Cosenza - UOC Ematologia
        • Contact:
        • Principal Investigator:
          • Massimo Gentile, MD
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
        • Principal Investigator:
          • Luigi Rigacci, MD
        • Contact:
      • Frosinone, Italy
        • Not yet recruiting
        • UOC Ematologia PO Spaziani
        • Contact:
        • Principal Investigator:
          • Alessandro Andriani, MD
      • Ivrea, Italy
        • Not yet recruiting
        • Ospedali Riuniti del Canavese - S.C. Medicina trasfusionale ed Ematologia
        • Contact:
      • Matera, Italy
      • Meldola, Italy
        • Not yet recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia
        • Contact:
      • Milano, Italy
        • Not yet recruiting
        • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
        • Contact:
      • Milano, Italy
      • Milano, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
        • Contact:
        • Principal Investigator:
          • Chiara Rusconi
      • Milano, Italy
        • Recruiting
        • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda - Ematologia
        • Contact:
        • Principal Investigator:
          • Francesca Gaia Rossi, MD
      • Napoli, Italy
        • Recruiting
        • AOU Università degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia
        • Contact:
        • Principal Investigator:
          • Antonello Sica, MD
      • Novara, Italy
        • Recruiting
        • AOU Maggiore della Carità di Novara - SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Luca Nassi, MD
      • Padova, Italy
      • Padova, Italy
        • Not yet recruiting
        • AOU di Padova - Ematologia
        • Contact:
        • Principal Investigator:
          • Livio Trentin, MD
      • Palermo, Italy
      • Parma, Italy
        • Not yet recruiting
        • AOU di Parma - UO Ematologia e CTMO
        • Contact:
      • Pavia, Italy
        • Recruiting
        • IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
        • Contact:
        • Principal Investigator:
          • Manuel Gotti, MD
      • Perugia, Italy
        • Recruiting
        • Ospedale S. Maria della Misericordia - Ematologia
        • Contact:
      • Piacenza, Italy
        • Recruiting
        • Ospedale Guglielmo da Saliceto - U.O. Ematologia
        • Contact:
      • Ravenna, Italy
        • Recruiting
        • Ospedale delle Croci - Ematologia
        • Contact:
        • Principal Investigator:
          • Monica Tani, MD
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
        • Contact:
      • Rimini, Italy
        • Recruiting
        • Ospedale degli Infermi di Rimini - U.O. di Ematologia
        • Contact:
        • Principal Investigator:
          • Anna Lia Molinari, MD
      • Roma, Italy
        • Not yet recruiting
        • AO Sant'Andrea - Ematologia
        • Contact:
        • Principal Investigator:
          • Maria Christina Cox, MD
      • Roma, Italy
      • Roma, Italy
        • Not yet recruiting
        • Università Cattolica S. Cuore - Ematologia
        • Contact:
      • Rozzano, Italy
        • Recruiting
        • Istituto Clinico Humanitas - U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Francesca Ricci, MD
      • Sassuolo, Italy
        • Recruiting
        • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
        • Principal Investigator:
          • Sara Bigliardi, MD
        • Contact:
      • Siena, Italy
        • Recruiting
        • AOU Senese - U.O.C. Ematologia
        • Contact:
      • Sondrio, Italy
        • Recruiting
        • Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio
        • Contact:
        • Principal Investigator:
          • Andrea Maria Soccodato, MD
      • Terni, Italy
        • Recruiting
        • A.O. S. Maria di Terni - S.C. Oncoematologia
        • Contact:
        • Principal Investigator:
          • Anna Marina Liberati, Prof
      • Torino, Italy
        • Recruiting
        • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
        • Contact:
        • Principal Investigator:
          • Federica Cavallo, MD
      • Torino, Italy
        • Recruiting
        • A.O.U. Citta della Salute e della Scienza di Torino - S.C. Ematologia
        • Principal Investigator:
          • Barbara Botto, MD
        • Contact:
      • Treviso, Italy
        • Recruiting
        • Ospedale Ca Foncello - S.C di Ematologia
        • Contact:
        • Principal Investigator:
          • Elisabetta Scarpa, MD
      • Tricase, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
June 2018-December 2025 (7.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
June 2018-December 2025 (7.5 years)
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.
June 2018-December 2025 (7.5 years)
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
June 2018-January 2024 (5.5 years, 6-7 month after the enrolment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi ONLUS

Investigators

  • Principal Investigator: Vittorio Ruggero Zilioli, MD, SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda, Milano - Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2018

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_ELDHL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Classical Hodgkin Lymphoma

Clinical Trials on Treatment for clinical practise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe