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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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. Città 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi ONLUS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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