Colorectal NeoplasmsCTCNCT02556281
Prognostic Value of Circulating Tumoral Free DNA Versus Circulating Tumoral Cells in Patients With Colorectal Cancer Stage II-III
A study testing Blood sampling in people with Colorectal Neoplasms, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2012to 3 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III
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
- Being tested
- Blood sampling
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling is done for patient with colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Patient with colorectal cancer | Experimental | Blood sampling is done for patient with colorectal cancer Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Number of patient with a first relapse
Number of patient with a first relapse, defined by discovering of new lesion or metastasis
Measured: 24 Months
Secondary outcomes (3)
Presence of tumoral cells in blood of patient with colorectal cancer
Presence of tumoral cells (yes/no) in blood of patient with colorectal cancer
Measured: Day 1
Number of tumoral cells in blood of patient with colorectal cancer
Quantification of tumoral cells in blood of patient with colorectal cancer
Measured: Day 1
Number of free tumoral DNA in blood of patient with colorectal cancer
Quantification of free tumoral DNA in blood of patient with colorectal cancer
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start15 Oct 2012
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean J TUECH, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556281
- Sponsor's protocol ID
- 2009/066/HP
- Acronym
- CTC
- Status last verified
- Oct 2025
- First submitted
- 18 Sep 2015
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGNOSTIC VALUE OF CIRCULATING TUMORAL FREE DNA Versus CIRCULATING TUMORAL CELLS IN PATIENTS WITH COLORECTAL CANCER STAGE II-III
- ClinicalTrials.gov ID
- NCT02556281
- Acronym / sponsor ID
- CTC / 2009/066/HP
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 15 Oct 2012 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with colorectal cancer | Experimental | Biological: Blood samplingBlood sampling is done for patient with colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling is done for patient with colorectal cancer | Biological | Patient with colorectal cancer |
Primary outcome
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
3 secondary outcomes
Presence of tumoral cells in blood of patient with colorectal cancer
Time frame: Day 1
Number of tumoral cells in blood of patient with colorectal cancer
Time frame: Day 1
Number of free tumoral DNA in blood of patient with colorectal cancer
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean J TUECH, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Colorectal Neoplasms, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of free tumoral DNA in blood of patient with colorectal cancer (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.