Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00855946
Study type	Observational
Source	University Hospital, Bordeaux
Contact
Status	Completed
Phase	N/A
Start date	May 2009
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05081024` - Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Not yet recruiting	`NCT04090450` - Optimisation of Radiotherapy in Rectal Cancer (ORREC)
Active, not recruiting	`NCT03300544` - Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer	Phase 1
Recruiting	`NCT06050447` - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Terminated	`NCT02233595` - Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Completed	`NCT02935309` - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma	Phase 1
Terminated	`NCT01887509` - Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology	N/A
Recruiting	`NCT05746195` - Optimization of Adaptive Text Messages for Cancer Survivors (OATS II)	N/A
Active, not recruiting	`NCT03365882` - S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery	Phase 2
Completed	`NCT02314182` - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis	Phase 3
Completed	`NCT02393755` - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer	Phase 1/Phase 2
Recruiting	`NCT04441580` - Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting	N/A
Terminated	`NCT03527784` - Prestoma-Trial for Parastomal Hernia Prevention	N/A
Recruiting	`NCT02107105` - Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Not yet recruiting	`NCT06328361` - Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer	N/A
Active, not recruiting	`NCT03436563` - M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability	Phase 1/Phase 2
Not yet recruiting	`NCT04814784` - Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum
Recruiting	`NCT05482516` - Evaluating Novel Therapies in ctDNA Positive GI Cancers	Phase 3
Completed	`NCT02368886` - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer	Phase 2
Active, not recruiting	`NCT02688712` - ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms