The Use of FDG-PET in Patient With Hodgkin Lymphoma: a Population Based Study From Northern Italy

This study has been completed.
Sponsor:
Collaborators:
Registro Tumori di Modena
Registro Tumori di Reggio Emilia
Registro Tumori di Parma
registro Tumori di Ferrara
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01248000
First received: November 23, 2010
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

Positron Emission Tomography (PET) represents a step forward in the definition of response to therapy in patients with Hodgkin Lymphoma (HL). In particular the use of PET for the early assessment of response has been described as the most important tool for predicting the risk of disease progression. As no data are available to support the use of early assessment of response for adapting and modifying subsequent treatment, the use of PET should be limited only to patients enrolled in clinical trials. Irrespective of recommendations PET scanning is included in the current management of patients with HL at baseline, mid treatment, end of treatment, and follow-up. So far no study has been performed to verify how PET is currently used in the clinical setting and to assess if and how results of PET scanning are used for supporting treatment and clinical decisions.


Condition Intervention
Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification
Procedure: FDG-PET

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Use of FDG Positron Emission Tomography (PET)in Patient With Hodgkin Lymphoma (HL) in the "Real World": a Population Based Study From Northern Italy

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: May 2009
Study Completion Date: May 2010
Groups/Cohorts Assigned Interventions
classical Hodgkin lymphoma
All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.
Procedure: FDG-PET
PET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All cases of classical Hodgkin lymphoma diagnosed between 2006 and 2008 in the province of Modena, Reggio Emilia, Parma and Ferrara will be considered eligible for this study.

Criteria

Inclusion Criteria:

  1. Histologically confirmed classical Hodgkin lymphoma according to the current World Health Organisation Classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted).
  2. Clinical stage I-IV.
  3. No previous chemotherapy, radiotherapy or other investigational drug for HL.

Exclusion Criteria:

1. None.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248000

Locations
Italy
Registro Tumori di Modena
Modena, Italy, 41124
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Registro Tumori di Modena
Registro Tumori di Reggio Emilia
Registro Tumori di Parma
registro Tumori di Ferrara
Investigators
Study Chair: Massimo Federico, MD Università di Modena e Reggio Emilia
  More Information

No publications provided

Responsible Party: Massimo Federico, Università di Modena e Reggio Emilia
ClinicalTrials.gov Identifier: NCT01248000     History of Changes
Other Study ID Numbers: PET-LH
Study First Received: November 23, 2010
Last Updated: November 24, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Studio Linfomi:
Hodgkin lymphoma
FDG-PET
prognostic factor
clinical trial

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

ClinicalTrials.gov processed this record on September 18, 2014