Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
18 Years
80 Years
Both
Rectal Adenocarcinoma
Trial Information
Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy
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.
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
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
differential expression of early seric biomarkers between good and bad responders.
Outcome Time Frame:
at inclusion and 24-48h after starting radiochemotherapy
Safety Issue:
No
Principal Investigator
Anne RULLIER, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Bordeaux, France
Authority:
France: French Data Protection Authority
Study ID:
CHUBX - 2008/25
NCT ID:
NCT00855946
Start Date:
May 2009
Completion Date:
May 2012
Related Keywords:
- Rectal Adenocarcinoma
- tumor response
- rectal adenocarcinoma
- preoperative radiochemotherapy
- Proteomic analysis
- MALDI-TOF-TOF
- rectal adenocarcinoma, tumor response after preoperative radiochemotherapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Carcinoma
- Rectal Neoplasms
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