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Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study (TEPELY)

This study is ongoing, but not recruiting participants.

Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00169598
  Purpose

This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.


Condition Intervention
Lymphoma
Procedure: positron emission tomography

MedlinePlus related topics:   CT Scans    Lymphoma   

ChemIDplus related topics:   Deoxyglucose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:   Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • The impact of positron emission tomography (PET) using fluorine-18-floro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma.

Secondary Outcome Measures:
  • Median progression free survival
  • The positive and negative likelihood- ratios, the positive and negative predictive values
  • The costs
  • The one-year survival rates
  • The quality of life of the patients

Estimated Enrollment:   80
Study Start Date:   February 2002

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Age over 18, with Hodgkin’s lymphoma or with large B and P cell non-Hodgkin’s lymphoma, or after a first-line chemotherapy with at least a residual mass or after induction chemotherapy or at progression.

Stem cell transplantation would be programmed. Patients were required to give their written informed consent.

Exclusion Criteria:

Progressive cancer or diagnosed less than 5 years, except cancer in situ of the cervix and basocell skin carcinoma, kidney insufficiency or diabetes. Patients would not be pregnant or lactating

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169598

Locations
France
Gilles Salles    
      Lyon, France, 69495

Sponsors and Collaborators
Hospices Civils de Lyon

Investigators
Principal Investigator:     Gilles SALLES, MD     Hospices Civils de Lyon    
  More Information


Study ID Numbers:   2000.232
First Received:   September 13, 2005
Last Updated:   April 26, 2007
ClinicalTrials.gov Identifier:   NCT00169598
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:
Lymphoma  
positron emission tomography  
stem cell transplantation  
therapeutic impact  

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Deoxyglucose
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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