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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Procedure: positron emission tomography


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: positron emission tomography|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, positron emission tomography, stem cell transplantation, therapeutic impact