Circulating Tumor CellsCTC-PancreasNCT02072616
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
A study testing Pancreatic adenocarcinoma diagnosis in people with Circulating Tumor Cells and Pancreatic Adenocarcinoma, run by University Hospital, Rouen at 1 site in France.
Trial summary
Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor Cells, Pancreatic Adenocarcinoma, Circulating Tumor DNA (KRAS)
- What is being tested?
- Pancreatic adenocarcinoma diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2014to 28 Feb 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
- Patient is male or female, and > 18 years of age
- Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
- Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
- Patient has agree to participate by giving written informed consent
Who cannot join
- metastatic pancreatic tumor
- cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
- minor patient under 18 years
- contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
- patient under guardianship
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.
- Being tested
- Pancreatic adenocarcinoma diagnosis
- Keywords
- Circulating Tumor Cells, pancreatic adenocarcinoma, circulating tumor DNA (KRAS), CA 19.9
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic adenocarcinoma diagnosisOther
| Study group | Role | What they receive |
|---|---|---|
| Sample for Circulating Tumoral Cells | Experimental | Sampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis Receives: Other: Pancreatic adenocarcinoma diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma
Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)
Measured: Day 1
Secondary outcomes (4)
diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma
Sensitivity, specificity and diagnostic accuracy of the detection of circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma.
Measured: Day 1
prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9
Sensitivity, specificity and diagnostic accuracy of the combined detection of CTCs and circulating tumor DNA (KRAS mutation) for the diagnosis of pancreatic adenocarcinoma
Measured: Day 1
Time to first recurrence or death
Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Measured: Month 36
Time to first recurrence or death
Time to first recurrence or death according to CTC and / or circulating tumor DNA and / or CA19.9
Measured: Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study start16 Sep 2014
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: Analysis not possible at the stage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor CellsStudies 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
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David SEFRIOUI, MD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072616
- Sponsor's protocol ID
- 2013/0141/HP
- Acronym
- CTC-Pancreas
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2014
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT02072616
- Acronym / sponsor ID
- CTC-Pancreas / 2013/0141/HP
- Keywords
- Circulating Tumor Cells, pancreatic adenocarcinoma, circulating tumor DNA (KRAS), CA 19.9
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analysis not possible at the stage
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Feb 2014 (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.
Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample for Circulating Tumoral Cells | Experimental | Other: Pancreatic adenocarcinoma diagnosisSampling of Circulating Tumoral Cells will be done after Pancreatic adenocarcinoma diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is male or female, and > 18 years of age
- Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
- Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
- Patient has agree to participate by giving written informed consent
Key exclusion criteria (6 listed)
- metastatic pancreatic tumor
- cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
- minor patient under 18 years
- contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
- patient under guardianship
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 |
|---|---|---|
| Pancreatic adenocarcinoma diagnosis | Other | Sample for Circulating Tumoral Cells |
Primary outcome
sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma
Time frame: Day 1
Ratio between the numbers of patients for which CTCs were observed and patients with pancreatic adenocarcinoma confirmed by pathology (FNA OR surgical specimen)
4 secondary outcomes
diagnostic performance of the circulating tumor DNA detection (KRAS) for the diagnosis of pancreatic adenocarcinoma
Time frame: Day 1
prognostic impact of circulating tumor cells and / or circulating tumor DNA (KRAS) and / or CA19.9
Time frame: Day 1
Time to first recurrence or death
Time frame: Month 36
Time to first recurrence or death
Time frame: Month 18
Results and safety
The study was stopped early (reason given: Analysis not possible at the stage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
David SEFRIOUI, MD principal investigator
UH 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 Pancreatic adenocarcinoma diagnosis in people with Circulating Tumor Cells and Pancreatic Adenocarcinoma, 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 4 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: stopped early, as of the sponsor's last update on 4 May 2026. 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 was stopped early (reason given: Analysis not possible at the stage). Results are not available in the source record.
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?
sensitivity of circulating tumor cells for the diagnostic of pancreatic adenocarcinoma (time frame: Day 1). 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 4 May 2026.