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Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy (PROTEORECTUM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855946
First Posted: March 5, 2009
Last Update Posted: May 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  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: Observational Model: Cohort
Time Perspective: 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

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 ]

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 ]

Biospecimen Retention:   Samples With DNA
whole blood

Enrollment: 46
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855946


Locations
France
Laboratoire d'anatomie pathologique, University Hospital, Bordeaux
Bordeaux, France, 33076
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
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00855946     History of Changes
Other Study ID Numbers: CHUBX - 2008/25
First Submitted: March 4, 2009
First Posted: March 5, 2009
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by University Hospital, Bordeaux:
tumor response
rectal adenocarcinoma
preoperative radiochemotherapy
Proteomic analysis
MALDI-TOF-TOF
rectal adenocarcinoma, tumor response after preoperative radiochemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases