Simultaneaous Detection of Quantitative Somatic Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study

Not Applicable

Completed

• Conditions: Colorectal Cancer; Stage II and III
• Interventions: Genetic: evaluation of the recurrence rate according to molecular analysis

• Registration Number: NCT02110329
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.

AIMS \& METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-06
• Study Completion: 2013-11
• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Last Update Submitted: 2014-04-07
• Study First Posted: 2014-04-10
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• age over 18
• localized colon cancer
• proven adenocarcinoma
• surgery R0
• no metastatic disease
• stage II or III
• WHO performance status 0, 1 or 2
• availaible frozen tissue
• written consent
• no major co-morbidities

Exclusion Criteria

• metastatic disease
• hereditary colorectal cancer
• rectal cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stage II-III colon cancer treated with surgery	evaluation of the recurrence rate according to molecular analysis	stage II-III colon cancer treated with surgery

Primary Outcome Measures

Name	Time	Method
Recurence rate according to molecular results	36 months	Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Secondary Outcome Measures

Name	Time	Method
Survival rate according to molecular results	60 months	Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Trial Locations

Locations (3)

Chu Lille; 🇫🇷 Lille, France

Chu Dijon; 🇫🇷 Dijon, France

Chu Hopitaux de Rouen; 🇫🇷 Rouen, France