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

NCT ID: NCT01248000

Last Updated: 2010-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Hodgkin lymphoma FDG-PET prognostic factor clinical trial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

FDG-PET

Intervention Type 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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Registro Tumori di Modena

UNKNOWN

Sponsor Role collaborator

Registro Tumori di Reggio Emilia

UNKNOWN

Sponsor Role collaborator

Registro Tumori di Parma

UNKNOWN

Sponsor Role collaborator

registro Tumori di Ferrara

UNKNOWN

Sponsor Role collaborator

Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role lead

Responsible Party

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Università di Modena e Reggio Emilia

Principal Investigators

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Massimo Federico, MD

Role: STUDY_CHAIR

Università di Modena e Reggio Emilia

Locations

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Registro Tumori di Modena

Modena, Modena, Italy

Site Status

Countries

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Italy

Other Identifiers

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PET-LH

Identifier Type: -

Identifier Source: org_study_id