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

NCT01248000 | Completed

• 1 other identifier: PET-LH
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Histologically Confirmed Classical Hodgkin Lymphoma According to the Current World Health Organisation Classification

Keywords

Hodgkin lymphoma; FDG-PET; prognostic factor; clinical trial

Outcome Measures

Primary Outcomes (3)

• Progression-free survival

  within 1 month after end of treatment

• Overall survival

  within 1 month after end of treatment

• Disease-free survival

  within 1 month after end of treatment

Study Arms (1)

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

Interventions

FDG-PET PROCEDURE

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)

classical Hodgkin lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. None.

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead
• Registro Tumori di Modena: collaborator
• Registro Tumori di Reggio Emilia: collaborator
• Registro Tumori di Parma: collaborator
• registro Tumori di Ferrara: collaborator

Study Sites (1)

Registro Tumori di Modena

Modena, Modena, 41124, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Massimo Federico, MD

  Università di Modena e Reggio Emilia

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 25, 2010
• Study Start: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: November 25, 2010

Record last verified: 2010-11

Locations

IT (1)