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
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Basic Information
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COMPLETED
NA
401 participants
INTERVENTIONAL
2010-05-31
2013-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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stage II-III colon cancer treated with surgery
stage II-III colon cancer treated with surgery
evaluation of the recurrence rate according to molecular analysis
Interventions
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evaluation of the recurrence rate according to molecular analysis
Eligibility Criteria
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Inclusion Criteria
* 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
* hereditary colorectal cancer
* rectal cancer
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Chu Dijon
Dijon, , France
Chu Lille
Lille, , France
Chu Hopitaux de Rouen
Rouen, , France
Countries
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Other Identifiers
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2007/040/HP
Identifier Type: -
Identifier Source: org_study_id
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