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:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00855946
First received: March 4, 2009
Last updated: May 7, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


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

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

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

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
Study First Received: March 4, 2009
Last Updated: May 7, 2013
Health Authority: France: French Data Protection Authority

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
Carcinoma
Rectal Neoplasms
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

ClinicalTrials.gov processed this record on April 17, 2014