Presence of Circulating Tumor DNA in Colorectal Cancer (ALGECOLS)

August 28, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Search for the Presence of Genetic Alteration in the Plasma of Patients With Stage II-III Colorectal Cancers: Prognosis Impact

Cancer is a DNA disease characterized by the presence of genetics alterations in cancer cells.

The recent studies underline that these recurring alterations must be considered as a good molecular marker. In fact, they could use for tumor DNA detection in different biological fluids.

So, the main purpose is to define the presence of circulating tumor DNA in the patients plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and MIRCOSATELLIE instability).

These molecular analysis will be done both in tumor and plasma samples,

This trial allows to characterize the prognostic value of circulating tumoral DNA presence in colorectal cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

Two major issues appear in improving the prognosis of cancer patients, the first is early detection and the second is the risk of recurrence or the early diagnosis of recurrence in order to propose the most appropriate treatment for patients.

Cancer is a DNA disease that is characterized by the acquisition by the tumor cell during carcinogenesis of a number of recurrent genetic alterations. The development of molecular tools that can easily characterize these abnormalities specific to tumor cells, allows us to consider their use in clinical practice. These genetic alterations could represent useful molecular markers for detecting the presence of tumor DNA in various biological fluids including plasma of cancer patients. This circulating tumor DNA, whose nature is confirmed by the similarity of genetic alterations with those observed from DNA extracted from tumor cells of the patients, represents a molecular marker of cancer available from a single sample and could be an alternative to the use of more conventional markers such as CEA. We propose in this study to confirm the predictive value on the risk of recurrence or metastasis of circulating tumor DNA in plasma of patients with colorectal cancer from a cohort study (250 patients with non-metastatic colorectal cancer (Stage II and III). This is a multicenter prospective study. The cohort of patients will be followed for a minimum period of 36 months. A biological analysis of the tumor in search for the main genetic alterations of colorectal cancer cells will be made (KRAS, NRAS, TP53, BRAF and APC mutations as well as the presence of a microsatellite instability). These same genetic alterations will be sought on a plasma sample taken before surgery and during follow-up (9 samples in total). The objectives of this study will be 1/to assess the prognostic value of the presence of circulating tumor DNA in plasma, by searching for an association between the risk of and the presence of genetic alteration in the plasma of these patients, 2/to search for a relationship between initial rate of circulating tumor DNA and the risk of local recurrence,3/ to characterize the relationship between the type of alterations in the plasma at the initial diagnosis of circulating tumor DNA and the risk of recurrence 4/ to assess during the follow-up the prognostic value of the occurrence of tumor circulating DNA.

Study Type

Observational

Enrollment (Actual)

261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • HEGP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

defined population : patients suffer from colorectal cancers in stage II-III

Description

Inclusion Criteria:

  • patients aged Superior to 18 and inferior to 85
  • Colon or rectal cancer stage II and III should be surgically treated
  • informed consent signed

Exclusion Criteria:

  • patients suffered from synchronous metastasis disease in initial cancer diagnosis
  • patients with 2 synchronous colorectal cancers
  • receiving chemotherapy or radiotherapy, before operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local recidivism or metastasis reappearance
Time Frame: 6 months after operation
6 months after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
specificity and global safety
Time Frame: 36 monhs after operation
36 monhs after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Pierre LAURENT-PUIG, HEGP/ Paris Descartes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P040433

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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