An observational study in Rectal Adenocarcinoma, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-05-09.
Sponsored by University Hospital, Bordeaux · Observational
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 46 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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patient with rectal carcinoma
Exclusion Criteria:
differential expression of early seric biomarkers between good and bad responders.
Time frame: at inclusion and 24-48h after starting radiochemotherapy
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
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux