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

NCT02556281 | Completed

• 1 other identifier: 2009/066/HP
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Presence of tumoral cells in blood of patient with colorectal cancer

  Day 1

• Number of tumoral cells in blood of patient with colorectal cancer

  Day 1

• Number of free tumoral DNA in blood of patient with colorectal cancer

  Day 1

Study Arms (1)

Patient with colorectal cancer

EXPERIMENTAL

Blood sampling is done for patient with colorectal cancer

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

Blood sampling is done for patient with colorectal cancer

Patient with colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean J TUECH, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: October 15, 2012
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

FR (1)