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

NCT ID: NCT02110329

Last Updated: 2014-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Colorectal Cancer Stage II and III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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stage II-III colon cancer treated with surgery

stage II-III colon cancer treated with surgery

Group Type NO_INTERVENTION

evaluation of the recurrence rate according to molecular analysis

Intervention Type GENETIC

Interventions

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evaluation of the recurrence rate according to molecular analysis

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon

Dijon, , France

Site Status

Chu Lille

Lille, , France

Site Status

Chu Hopitaux de Rouen

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2007/040/HP

Identifier Type: -

Identifier Source: org_study_id

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