Proteomic Approach Using Matrix-Assisted Laser Desorption/Ionization Tandem Time-of-Flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00855946

Sponsored by:

University Hospital, Bordeaux

Information provided by:

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT00855946

Purpose

Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

Condition
Rectal Adenocarcinoma

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Proteomic Approach Using Matrix-Assisted Laser Desorption/Ionization Tandem Time-of-Flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

differential expression of early seric biomarkers between good and bad responders. [ Time Frame: at inclusion and 24-48h after starting radiochemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

modifications of isolated biomarkers within presurgical period [ Time Frame: at inclusion, 24-48h after initiation of radiochemotherapy, at the end of radiochemotherapy (6th week) and before surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood

Estimated Enrollment:	50
Study Start Date:	May 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Detailed Description:

Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The purpose of this prospective monocentric study is to look for early seric biomarkers predictive of tumor response (good and bad responders) in patients treated by preoperative radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera will be collected before, during preoperative treatment and before surgery, and analysed using a MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response in order to identify potential early biomarkers of tumor response.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patient with rectal carcinoma

Criteria

Inclusion Criteria:

T3T4 or N+ M0 rectal carcinoma
histologically-proven adenocarcinoma
from 0 to 15 cm from the anal verge
patient is at least 18 years of age
ECOG performance status </= 2
Patient and doctor have signed informed consent

Exclusion Criteria:

Metastatic disease
T1-T2 N0 rectal carcinoma
Contra indication of radiotherapy or chemotherapy
History of cancer
Severe renal insufficiency
Symptomatic cardiac or coronary insufficiency
Patient included in a trial
Previous radiotherapy or chemotherapy for this cancer
No contraceptive treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855946

Contacts

Contact: Anne RULLIER, MD, PhD	00 33 5 56 79 56 02	anne.rullier@chu-bordeaux.fr
Contact: Stéphanie GUILLON	33 05 56 79 58 10	stephanie.guillon@chu-bordeaux.fr

Locations

France
Laboratoire d'anatomie pathologique, University Hospital, Bordeaux	Recruiting
Bordeaux, France, 33076
Contact: Anne RULLIER, MD 00 33 05 56 79 56 02 anne.rullier@chu-bordeaux.fr
Contact: Stephanie GUILLON 00 33 05 56 79 58 10 stephanie.guillon@chu-bordeaux.fr
Principal Investigator: Anne RULLIER, MD
Sub-Investigator: Christophe LAURENT, MD
Sub-Investigator: eric RULLIER, MD
Sub-Investigator: Sébastien LEPREUX, MD
Sub-Investigator: Veronique VENDRELY, MD
Sub-Investigator: Marc BONNEU, Professor

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

Principal Investigator:	Anne RULLIER, MD	University Hospital Bordeaux, France
Study Chair:	Paul PEREZ, MD	University Hospital Bordeaux, France

Responsible Party:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	CHUBX - 2008/25
Study First Received:	March 4, 2009
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00855946 History of Changes
Health Authority:	France: French Data Protection Authority