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COMPLETED
NCT02110329
NA

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

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

401

Start Date

2010-05

Completion Date

2013-11

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

GENETIC

evaluation of the recurrence rate according to molecular analysis

Locations (3)

Chu Dijon

Dijon, France

Chu Lille

Lille, France

Chu Hopitaux de Rouen

Rouen, France