Cancer of PancreasEUS-CTCNCT04677244
Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
A study testing Blood sample in portal vein in people with Cancer of Pancreas, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Blood sample in portal vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 11 Nov 2021to 1 Nov 2025
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 40-85 years old;
- BMI< 30 kg/m2;
- Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
- Affiliation to, or beneficiary of, a social security scheme.
Who cannot join
- Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
- Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
- Biliary drainage or attempt at prior biliary drainage outside the center ;
- Preliminary oncological treatment for pancreatic pathology covered by the study;
- Clinical and/or image-visible (CT/MRI) carcinosis ;
- Ascites visible on imaging (CT/MRI) ;
- Impossibility to undergo the medical follow-up of the trial for geographical, social or psychological reasons;
- Contraindications to an endoscopic procedure.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
GENRE Dominique, MD, + 33 4 91 22 37 78 ext. 033, drci.up@ipc.unicancer.fr
About this study
Official title: Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care
The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.
Read the detailed description
The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.
In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:
- the level of circulating tumor cells (CTC) per milliliter of blood,
- cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).
A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.
Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.
- Conditions
- Cancer of Pancreas
- Being tested
- Blood sample in portal vein
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample in portal veinProcedure or surgery
A 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Portal vein blood sample | Experimental | Not described Receives: Procedure: Blood sample in portal vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure impact
Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start11 Nov 2021
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective monocentric study
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice CAILLOL, MD, Principal investigator, Paoli Calmettes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677244
- Sponsor's protocol ID
- EUS-CTC-IPC 2019-056
- Acronym
- EUS-CTC
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care
- ClinicalTrials.gov ID
- NCT04677244
- Acronym / sponsor ID
- EUS-CTC / EUS-CTC-IPC 2019-056
- Conditions
- Cancer of Pancreas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 21 Dec 2020 (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 work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.
Detailed description
The study will include 42 evaluable patients suspected of having pancreatic cancer and for whom an echo-endoscopic biopsy (EUS-FNA) and/or biliary drainage is planned.
In these patients, a 6 ml blood sample will be taken from the portal vein before and after the echo-endoscopic biopsy of the pancreatic mass to determine:
- the level of circulating tumor cells (CTC) per milliliter of blood,
- cytological characteristics of CTCs (isolated, clustered, giant, and clustered including other cell types).
A peripheral blood sample will also be taken to evaluate peripheral CTC levels and cytological characteristics before and after biopsy, as well as one month after biopsy.
Patients will be evaluated every 6 months as part of their follow-up to assess the progression of their pathology and morbidity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective monocentric study
| Arm | Type | Receives |
|---|---|---|
| Portal vein blood sample | Experimental | Procedure: Blood sample in portal vein |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 40-85 years old;
- BMI< 30 kg/m2;
- Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic biopsy and/or biliary drainage is planned;
- Affiliation to, or beneficiary of, a social security scheme.
Key exclusion criteria (8 listed)
- Woman who is pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
- Person in an emergency situation, person of full age subject to a legal protection measure, or unable to express consent;
- Biliary drainage or attempt at prior biliary drainage outside the center ;
- Preliminary oncological treatment for pancreatic pathology covered by the study;
- Clinical and/or image-visible (CT/MRI) carcinosis ;
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 sample in portal veinA 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure. | Procedure or surgery | Portal vein blood sample |
Primary outcome
Procedure impact
Time frame: 5 minutes after procedure
Rate of patients with a CTC increase > 4 cells/ml in the portal system after the endoscopic procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
Fabrice CAILLOL, MD principal investigator
Paoli Calmettes Institute
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 sample in portal vein in people with Cancer of Pancreas, run by Institut Paoli-Calmettes 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 8 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure impact (time frame: 5 minutes after procedure). 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 9 Apr 2024.