Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427817
Status:
COMPLETED
Last Update Posted:
2011-10-06
First Post:
2007-01-26
Brief Title:
PRO-STATESearch for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
PRO-STATE Prognostic Interest of Serum Protein Profiles of Patients Undergoing a Prostate Biopsy Search for a Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins
Detailed Description:
In men prostate carcinoma is the first cancer and the second cause of death by cancer It is a slowly evolving disease with no prognostic marker of poor outcome
Currently the Prostate Specific Antigen PSA is the only available biological marker It is a tissue marker and not a tumoral pathology control
This is why new tissue markers are urgently needed to select patients with unfavourable evolution in order to treat them rapidly by more effective methods such as chemotherapy hormonotherapy or radiotherapy This could improve survival time and quality of life
Proteomic and clinical data comparison could point to new relevant molecules and permit the development of new biological tests for routine use
SELDI-TOF-MS Surface Enhanced Laser DesorptionIonisation Mass Spectrometry permits an extremely sensitive analysis of proteins This method has been substantially ratified by the literature and a number of markers have already been identified particularly for several cancer pathologies
As far as prostate carcinomas are concerned previous proteomic researches on serum have led to diagnostic parameters differentiating healthy patients patients with benign lesion and patients having malignant lesions However at present no relevant protein has been identified Moreover no study has been carried out to characterize fast-developing lesions in order to anticipate response to treatments
The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins
The main judgement criteria will be intensity peaks in the protein profile area and height with reference to combined criteria PSA rate clinical stage Gleason score
Two groups will be compared
Group 1 Control negative biopsy
Group 2 Prostate carcinoma positive biopsy
This group will be subdivided
Group 2a favourable prognostic according to AMICO classification
Group 2b intermediate or unfavourable prognostic according to AMICO classification
This will contribute to setting up an aftercare database combining clinical data with biological data and protein profile
Currently the Prostate Specific Antigen PSA is the only available biological marker It is a tissue marker and not a tumoral pathology control
This is why new tissue markers are urgently needed to select patients with unfavourable evolution in order to treat them rapidly by more effective methods such as chemotherapy hormonotherapy or radiotherapy This could improve survival time and quality of life
Proteomic and clinical data comparison could point to new relevant molecules and permit the development of new biological tests for routine use
SELDI-TOF-MS Surface Enhanced Laser DesorptionIonisation Mass Spectrometry permits an extremely sensitive analysis of proteins This method has been substantially ratified by the literature and a number of markers have already been identified particularly for several cancer pathologies
As far as prostate carcinomas are concerned previous proteomic researches on serum have led to diagnostic parameters differentiating healthy patients patients with benign lesion and patients having malignant lesions However at present no relevant protein has been identified Moreover no study has been carried out to characterize fast-developing lesions in order to anticipate response to treatments
The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins
The main judgement criteria will be intensity peaks in the protein profile area and height with reference to combined criteria PSA rate clinical stage Gleason score
Two groups will be compared
Group 1 Control negative biopsy
Group 2 Prostate carcinoma positive biopsy
This group will be subdivided
Group 2a favourable prognostic according to AMICO classification
Group 2b intermediate or unfavourable prognostic according to AMICO classification
This will contribute to setting up an aftercare database combining clinical data with biological data and protein profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None