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Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III (CTC)

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ClinicalTrials.gov Identifier: NCT02556281
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

After curative surgical resection, detection of metastatic lymph node remains the main prognostic validated criteria on which is based the decision of adjuvant therapy. To date, none of the molecular alterations, identified as potentially predictive factor, are used in routine for therapeutic decision. The circulating markers, either in the form of free circulating DNA or in the form of circulating tumoral cells seems important potential candidates. To investigators knowledge, only one study estimated with several interesting results the prognostic interest of a coupled detection of the free circulating mutant DNA (gene KRAS) and by the hypermethylation of the p16 gene. Definitive conclusions remain however difficult to achieve because of the small number of patient included (n=58) and the fact that this study included different stages. For colorectal cancer a Chinese team presented a series of results suggesting that the presence of CTC during the postoperative course is a factor significantly related to the risk of recurrence. In multivariate analysis integrating the lymph node status and the vascular invasion, the presence of CTC appeared as an independent factor for recurrence with a hazard ratio of 29.5.

The aim of the present study is to compare the prognostic value of two circulating tumoral markers KRAS point mutations and RASSF2A methylation (free tumoral DNA) and Circulating tumoral cells (CTC). The primary objective is to compare sensibility and specificity of two circulating markers (free tumoral DNA and tumoral cells) on 2 years disease free survival rate. Secondary objective is to confirm the prognostic value of circulating free tumoral DNA and circulating tumoral cells in localised colorectal cancer.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Biological: Blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III
Actual Study Start Date : October 15, 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient with colorectal cancer
Blood sampling is done for patient with colorectal cancer
Biological: Blood sampling
Blood sampling is done for patient with colorectal cancer




Primary Outcome Measures :
  1. Presence of free tumoral DNA in blood of patient with colorectal cancer [ Time Frame: Day 1 ]
    Presence of free tumoral DNA (yes/no) in blood of patient with colorectal cancer

  2. Number of patient with a first relapse [ Time Frame: 24 Months ]
    Number of patient with a first relapse, defined by discovering of new lesion or metastasis


Secondary Outcome Measures :
  1. Presence of tumoral cells in blood of patient with colorectal cancer [ Time Frame: Day 1 ]
    Presence of tumoral cells (yes/no) in blood of patient with colorectal cancer

  2. Number of tumoral cells in blood of patient with colorectal cancer [ Time Frame: Day 1 ]
    Quantification of tumoral cells in blood of patient with colorectal cancer

  3. Number of free tumoral DNA in blood of patient with colorectal cancer [ Time Frame: Day 1 ]
    Quantification of free tumoral DNA in blood of patient with colorectal cancer



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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:

  • Male or female, age superior to 18 years.
  • Histologically confirmed colonic or rectal adenocarcinoma.
  • stage II or III (TNM classification).
  • Curative resection (R0)
  • Absence of metastasis (abdominal ultrasonography or CTscan and pulmonary Rx or CTscan) in exams performed within 4 weeks.
  • ECOG performance status <3.
  • Signed and dated informed consent document.

Exclusion Criteria:

  • Metastatic disease.
  • Familial adenomatous polyposis
  • Prior chemotherapy and or radiotherapy within 6 weeks
  • Medical history of cancer within 5 years except: basocellular cutaneous neoplasia and intraepithelial neoplasia of the cervix

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): NCT02556281


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Jean J TUECH, Pr Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02556281     History of Changes
Other Study ID Numbers: 2009/066/HP
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases