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

18 Years
85 Years
Open (Enrolling)
Colorectal Neoplasms

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

local recidivism or metastasis reappearance

Outcome Time Frame:

6 months after operation

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

HEGP/ Paris Descartes University


France: Ministry of Health

Study ID:




Start Date:

November 2005

Completion Date:

March 2014

Related Keywords:

  • Colorectal Neoplasms
  • Genetics modifications
  • colorectal cancer
  • prognosis aim
  • DNA
  • Plasma
  • Neoplasms
  • Colorectal Neoplasms