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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 (Code Barre)

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ClinicalTrials.gov Identifier: NCT02110329
Recruitment Status : Completed
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage II and III Genetic: evaluation of the recurrence rate according to molecular analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : May 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
No Intervention: stage II-III colon cancer treated with surgery
stage II-III colon cancer treated with surgery
Genetic: evaluation of the recurrence rate according to molecular analysis



Primary Outcome Measures :
  1. Recurence rate according to molecular results [ Time Frame: 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 :
  1. Survival rate according to molecular results [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110329


Locations
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France
Chu Dijon
Dijon, France, 21079
Chu Lille
Lille, France, 59037
Chu Hopitaux de Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02110329     History of Changes
Other Study ID Numbers: 2007/040/HP
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by University Hospital, Rouen:
colorectal cancer
stage II and III
somatic quantitative molecular alterations
Qantitative Multiplex Pcr of Short fluorescent Fragments method (QMPSF)
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases