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
Information provided by:
Hospices Civils de Lyon
First received: September 13, 2005
Last updated: April 26, 2007
Last verified: April 2007
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.
Procedure: positron emission tomography
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00169598
|Lyon, France, 69495 |
Hospices Civils de Lyon
||Gilles SALLES, MD
||Hospices Civils de Lyon
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 13, 2005
||April 26, 2007
||France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Keywords provided by Hospices Civils de Lyon:
positron emission tomography
stem cell transplantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Immune System Diseases
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action