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

Colorectal Neoplasms Clinical Trial

— CTC  

Official title:

PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02556281
• Other study ID #: 2009/066/HP
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2012
• Est. completion date: September 2019

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Biological:
• Blood sampling
Blood sampling is done for patient with colorectal cancer

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of free tumoral DNA in blood of patient with colorectal cancer	Presence of free tumoral DNA (yes/no) in blood of patient with colorectal cancer	Day 1
Primary	Number of patient with a first relapse	Number of patient with a first relapse, defined by discovering of new lesion or metastasis	24 Months
Secondary	Presence of tumoral cells in blood of patient with colorectal cancer	Presence of tumoral cells (yes/no) in blood of patient with colorectal cancer	Day 1
Secondary	Number of tumoral cells in blood of patient with colorectal cancer	Quantification of tumoral cells in blood of patient with colorectal cancer	Day 1
Secondary	Number of free tumoral DNA in blood of patient with colorectal cancer	Quantification of free tumoral DNA in blood of patient with colorectal cancer	Day 1