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

March 4, 2009
May 7, 2013
May 2009
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00855946 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Non-Probability Sample

patient with rectal carcinoma

Rectal Adenocarcinoma
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00855946
CHUBX - 2008/25
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Anne RULLIER, MD University Hospital Bordeaux, France
Study Chair: Paul PEREZ, MD University Hospital Bordeaux, France
University Hospital, Bordeaux
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP