Pancreatic Ductal Adenocarcinoma (PDAC)PANC-CTCNCT03032913
Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Blood samples and Portal vein blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2017to 13 Nov 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer
Who may be able to join
- Patient with informed consent
- Patient with health care coverage
- Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
- Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure
Who cannot join
- Patients <18 or under tutelage
- Patient with recent chemotherapy or radiotherapy
- Pregnant or lactating woman
- Patient with negative or non-informative biopsy
- Patient with technically unserectable disease
Trial locations and contacts
1 site in 1 country.
About this study
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival <5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- Blood samples, Portal vein blood sample
- Keywords
- Pancreas, Pancreatic, Cancer, Circulating tumor cell (CTC), Adenocarcinoma, Ductal, Exosome
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
Blood samples for both group
Portal vein blood sampleProcedure or surgery
Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic ductal adenocarcinoma patients | Patients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC Receives: Procedure: Blood samples; Procedure: Portal vein blood sample | |
| Non-cancer patients | Patients with no Cancer Receives: Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments
Measured: 6 months
Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.
Measured: 18 months
Secondary outcomes (2)
Step 1: reproducibility of CTC detection with the 3 methods
Estimation with bilateral confidence interval of 95%. A mixed affect linear regression will be operated to obtain this estimation.
Measured: 6 months
Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne BUSCAIL, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032913
- Sponsor's protocol ID
- CHUBX 2015/26
- Acronym
- PANC-CTC
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC
- ClinicalTrials.gov ID
- NCT03032913
- Acronym / sponsor ID
- PANC-CTC / CHUBX 2015/26
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Pancreas, Pancreatic, Cancer, Circulating tumor cell (CTC), Adenocarcinoma, Ductal, Exosome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 26 Jan 2017 (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.
The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) incidence has increased with a high rate during the past few years (+4.7% per year between 2005 and 2012, source InfoCancer 2013). No cure is currently available for this deadly disease, with an overall survival <5%. Survival can reach 20% when surgery is possible, giving the best chance to the patients. If patients present locally advance disease, it is crucial to quickly establish resectability to avoid unneeded and even deleterious surgery in patients with metastatic stages. It is also important to increase the rate of true R0 resection with effective preoperative therapy. However, when the cancer is suspected, neoadjuvant chemotherapies are often delayed because the mandatory histologic proof is difficult to make with non-informative biopsies. It is necessary to find new markers to help for rapid diagnosis that could allow neoadjuvant therapies and surgery when anatomo-pathologic proof is not available. New developments in the field of liquid biopsy hold great promise in providing valuable information for diagnosis assistance. The project will be run in two steps. First, several methods will be compared for tumor cell recovery after cell spiking in blood of non-cancer patients and pancreatic cell line onco-exosomes will characterized by flow cytometry. Second the best method will be used to detect and enumerate CTCs in 20 PDAC patients and 20 non-cancer patients. In parallel GPC1+ exosomes from patients' plasmas will be quantified. Diagnosis accuracy will be established and compared. Correlations between circulating tumor elements presence and clinical and biological parameters will be evaluated at the time of the diagnosis. Patient clinical outcome will be assessed according to initial circulating element quantification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic ductal adenocarcinoma patients | – | Procedure: Blood samples, Procedure: Portal vein blood samplePatients with recent diagnosis of pancreatic ductal adenocarcinoma (PDAC) or with strong suspicion PDAC |
| Non-cancer patients | – | Procedure: Blood samplesPatients with no Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with recent diagnosis of Pancreatic Ductal Adenocarcinoma and 20 patients with no cancer
Key inclusion criteria (4 listed)
- Patient with informed consent
- Patient with health care coverage
- Group of PDAC patients: Patient with resectable lesion with suspicion or recent diagnosis of PDAC recruited in the surgery department
- Group of non-cancer patients: Patients in the surgery department without cancer lesion, Patients with intestine inflammatory disease, Patients with gastric bypass or sleeve gastrectomy procedure
Key exclusion criteria (5 listed)
- Patients <18 or under tutelage
- Patient with recent chemotherapy or radiotherapy
- Pregnant or lactating woman
- Patient with negative or non-informative biopsy
- Patient with technically unserectable disease
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 samplesBlood samples for both group | Procedure or surgery | Non-cancer patients, Pancreatic ductal adenocarcinoma patients |
| Portal vein blood samplePortal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group | Procedure or surgery | Pancreatic ductal adenocarcinoma patients |
Primary outcome
Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments
Time frame: 6 months
Step 2: diagnostic accuracy of the best CTC detection method and onco-exosome quantification for pancreatic adenocarcinoma diagnosis.
Time frame: 18 months
2 secondary outcomes
Step 1: reproducibility of CTC detection with the 3 methods
Time frame: 6 months
Step 2: correlation between CTCs presence and numbers or onco-exosome concentration with clinical and biological parameters and with patient clinical outcome
Time frame: 18 months
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 10 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
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RecruitingPhase 3
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RecruitingPhase 3
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RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
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RecruitingPhase 3
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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.
Etienne BUSCAIL principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by University Hospital, Bordeaux 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 5 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 10 Apr 2018. 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?
Step 1: sensitivity of CTC detection with 3 methods in cell spiking experiments (time frame: 6 months). 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 10 Apr 2018.