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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00169598
First received: September 13, 2005
Last updated: April 26, 2007
Last verified: April 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


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
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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

No publications provided

ClinicalTrials.gov Identifier: NCT00169598     History of Changes
Other Study ID Numbers: 2000.232
Study First Received: September 13, 2005
Last Updated: April 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on September 18, 2014