Colorectal CancerADNCircNCT02813928
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
A study testing ccfDNA analysis in people with Colorectal Cancer, run by University Hospital, Limoges at 19 sites in France.
Trial summary
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ccfDNA analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 19 sitesFrance
- Study dates
- Jul 2016to Jul 2022
- 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
- Age ≥ 18 years
- Primary diagnosis of stages II and III CRC:
- is already operated and histological proven (biopsy at least)
- is patient that must be operated: curative treatment for stages II and III CRC
- Patient benefiting from a program personalized by care
- Written informed consent
Who cannot join
- Patient already treated for stages II and III CRC and in surveillance
- Patient with indication or with palliative treatment
- Pregnant or nursing patients
- Known pregnancy
- Difficulties to understand the protocol
- Patients under protection measure (guardianship, curatorship, protection of justice)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Aurillac Hospital
Aurillac, 15000
Bergonie institute
Bordeaux, 33000
Bordeaux University Hospital
Bordeaux, 33000
Brive Hospital
Brivé, 19000
Les Cèdres clinical
Brive-la-Gaillarde, 19000
Cahors Hospital
Cahors, 46000
Clermont Ferrand University Hospital
Clermont-Ferrand
Gueret Hospital
Guéret, 23000
La marche clinical
Guéret, 23000
Limoges Hospital
Limoges, 87 042
Montpellier Institute
Montpellier, 34000
Montpellier University Hospital
Montpellier, 34000
Moulins Hospital
Moulins, 03000
Saint Antoine AP-HP
Paris, 75012
Perigueux clinical
Périgueux, 24000
Périgueux Hospital
Périgueux, 24000
Saint Junien Hospital
Saint-Junien, 87000
Sainte feyre Hospital
Sainte-Feyre, 23000
Vichy Hospital
Vichy, 03200
About this study
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.
Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.
Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.
- Conditions
- Colorectal Cancer
- Being tested
- ccfDNA analysis
- Keywords
- ColoRectal Cancer, Cancerology, Translational Research, ccfDNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ccfDNA analysisGenetic
The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance
| Study group | Role | What they receive |
|---|---|---|
| ccfDNA analysis | Experimental | The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance. Receives: Genetic: ccfDNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2021
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813928
- Sponsor's protocol ID
- I15031
- Acronym
- ADNCirc
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: the data are anonymized
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
- ClinicalTrials.gov ID
- NCT02813928
- Acronym / sponsor ID
- ADNCirc / I15031
- Conditions
- Colorectal Cancer
- Keywords
- ColoRectal Cancer, Cancerology, Translational Research, ccfDNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 27 Jun 2016 (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.
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.
Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.
Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ccfDNA analysis | Experimental | Genetic: ccfDNA analysisThe level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Primary diagnosis of stages II and III CRC:
- is already operated and histological proven (biopsy at least)
- is patient that must be operated: curative treatment for stages II and III CRC
- Patient benefiting from a program personalized by care
Key exclusion criteria (6 listed)
- Patient already treated for stages II and III CRC and in surveillance
- Patient with indication or with palliative treatment
- Pregnant or nursing patients
- Known pregnancy
- Difficulties to understand the protocol
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 |
|---|---|---|
| ccfDNA analysisThe level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance | Genetic | ccfDNA analysis |
Primary outcome
The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.
Time frame: 3 years
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 2 Aug 2022.
- Individual participant dataSharing planned: No. the data are anonymized
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ccfDNA analysis in people with Colorectal Cancer, run by University Hospital, Limoges at 19 sites 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 6 inclusion and 6 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up. (time frame: 3 years). 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 2 Aug 2022.