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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

Tracking Information
First Submitted Date  ICMJE September 18, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE October 15, 2012
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02556281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III
Official Title  ICMJE PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Biological: Blood sampling
Blood sampling is done for patient with colorectal cancer
Study Arms  ICMJE Experimental: Patient with colorectal cancer
Blood sampling is done for patient with colorectal cancer
Intervention: Biological: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
216
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
293
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556281
Other Study ID Numbers  ICMJE 2009/066/HP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Rouen
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean J TUECH, Pr Rouen University Hospital
PRS Account University Hospital, Rouen
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP