Breast CancerPeriop ctDNANCT03284684
Kinetics of Perioperative Circulating DNA in Cancer Surgery
An observational study of Breast Cancer and Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colon Cancer
- What is being tested?
- Blood test
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Jan 2018to 11 Nov 2018
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is aged between 18-75
- Patient must weigh >40kg
- The patient will receive adjusted carcinological surgery
- Indication of curative surgery
- The patient has already undergone tumoral biopsy prior to surgery
- The patient has stage M0 cancer of either colon (right or left colonic adenocarcinoma), prostate (adenocarcinoma) or breast (infiltrating carcinoma)
Who cannot join
- The subject is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is pregnant, parturient or breast feeding
- Chronic alcoholism
Show all 11Show fewer
- The patient has received radiotherapy or chemotherapy periopratively
- Cancer other than colon, breast or prostate
- The patient has currently or in the past, had a cancerous lesion
- Neo-adjuvant therapy (immunotherapy, radiotherapy, chemotherapy)
- Emergency cancer surgery
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Montpellier
Montpellier, 34295
Institut de Cancérologie Montpellier
Montpellier, 34298
CHU Nimes
Nîmes, 30029
About this study
The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.
- Conditions
- Breast Cancer, Prostate Cancer, Colon Cancer
- Being tested
- Blood test
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
plasma concentration of circulating DNA of specific genes
| Study group | Role | What they receive |
|---|---|---|
| circulating DNA plasma level test | Not described Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in concentration of total mutant circulating DNA
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in proportion of mutant circulating DNA
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in integrity index of circulating DNA for ACTB gene
concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments
Measured: Nine timepoints between Day-1 to Day 3
Change in integrity index of circulating DNA for KRAS gene
concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments
Measured: Nine timepoints between Day-1 to Day 3
Secondary outcomes (5)
Change in plasma concentration of long (~ 290bp) fragments of ACTB gene
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of short (~ 145bp) fragments of KRAS gene
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of long (~ 300bp) fragments of KRAS gene
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of mutant KRAS DNA fragments
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of BRAF DNA fragments with V600E mutation
ng/mL in plasma
Measured: Nine timepoints between Day-1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start22 Jan 2018
- Primary completion11 Nov 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284684
- Sponsor's protocol ID
- NIMAO/2016/PC-01
- Other IDs
- 2017-A00950-53
- Acronym
- Periop ctDNA
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2017
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kudriavtsev A, Pastor B, Mirandola A, Pisareva E, Gricourt Y, Capdevila X, Thierry AR, Cuvillon P. Association of the immediate perioperative dynamics of circulating DNA levels and neutrophil extracellular traps formation in cancer patients. Precis Clin Med. 2024 Mar 27;7(2):pbae008. doi: 10.1093/pcmedi/pbae008. eCollection 2024 Jun.
PubMed 38699382
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Perioperative Circulating DNA in Cancer Surgery
- ClinicalTrials.gov ID
- NCT03284684
- Acronym / sponsor ID
- Periop ctDNA / NIMAO/2016/PC-01
- Conditions
- Breast Cancer, Prostate Cancer, Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 11 Nov 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- 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.
The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| circulating DNA plasma level test | – | Other: Blood test |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for non-metastatic solid tumors: colon, breast and prostate.
Key inclusion criteria (8 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is aged between 18-75
- Patient must weigh >40kg
- The patient will receive adjusted carcinological surgery
Key exclusion criteria (11 listed)
- The subject is in a period of exclusion determined by a previous study
- The patient is under safeguard of justice
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is pregnant, parturient or breast feeding
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 testplasma concentration of circulating DNA of specific genes | Other | circulating DNA plasma level test |
Primary outcome
Change in concentration of total mutant circulating DNA
Time frame: Nine timepoints between Day-1 to Day 3
ng/mL in plasma
Change in proportion of mutant circulating DNA
Time frame: Nine timepoints between Day-1 to Day 3
ng/mL in plasma
Change in integrity index of circulating DNA for ACTB gene
Time frame: Nine timepoints between Day-1 to Day 3
concentration of long ACTB ctDNA fragments/concentration of short ACTB ctDNA fragments
Change in integrity index of circulating DNA for KRAS gene
Time frame: Nine timepoints between Day-1 to Day 3
concentration of long KRAS ctDNA fragments/concentration of short KRAS ctDNA fragments
5 secondary outcomes
Change in plasma concentration of long (~ 290bp) fragments of ACTB gene
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of short (~ 145bp) fragments of KRAS gene
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of long (~ 300bp) fragments of KRAS gene
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of mutant KRAS DNA fragments
Time frame: Nine timepoints between Day-1 to Day 3
Change in plasma concentration of BRAF DNA fragments with V600E mutation
Time frame: Nine timepoints between Day-1 to Day 3
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 1 Dec 2025.
- Results publication: PubMed 38699382Kudriavtsev A, Pastor B, Mirandola A, Pisareva E, Gricourt Y, Capdevila X, Thierry AR, Cuvillon P. Association of the immediate perioperative dynamics of circulating DNA levels and neutrophil extracellular traps formation in cancer patients. Precis Clin Med. 2024 Mar 27;7(2):pbae008. doi: 10.1093/pcmedi/pbae008. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Centre Hospitalier Universitaire de Nīmes at 3 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 8 inclusion and 11 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Change in concentration of total mutant circulating DNA (time frame: Nine timepoints between Day-1 to Day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284684, which also lists 1 linked publication.
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 1 Dec 2025.