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

NCT00855946 | Completed

• 1 other identifier: CHUBX - 2008/25
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenocarcinoma

Keywords

tumor response; rectal adenocarcinoma; preoperative radiochemotherapy; Proteomic analysis; MALDI-TOF-TOF; rectal adenocarcinoma, tumor response after preoperative radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• differential expression of early seric biomarkers between good and bad responders.

  at inclusion and 24-48h after starting radiochemotherapy

Secondary Outcomes (1)

• modifications of isolated biomarkers within presurgical period

  at inclusion, 24-48h after initiation of radiochemotherapy, at the end of radiochemotherapy (6th week) and before surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with rectal carcinoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Laboratoire d'anatomie pathologique, University Hospital, Bordeaux

Bordeaux, 33076, France

Location

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Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anne RULLIER, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Paul PEREZ, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

FR (1)