ClinicalTrials.gg
RecruitingNCT04677244EUS-CTCUpdated Apr 9, 2024

Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

An interventional study of Blood sample in portal vein in Cancer of Pancreas, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Institut Paoli-Calmettes · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 5 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
40 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes — 7 open to participants now, 8 under way, none of them phase 3. Pancreatic Neoplasms · Institut Paoli-Calmettes.

Planned enrollment
8th of 12
42 · median 75
Started
2021
with 1 other
No phase
9 of 19
4 open now
Registered
13th of 19
by date

Among the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, this one is the 8th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2021, is one of 9 with no phase, and was the 13th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

7 of the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 40 Years to 85 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Cancer of Pancreas
04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women aged 40-85 years old;
  • \< 30 kg/m2;
  • Patients suspected of having pancreatic cancer for whom an ultrasound endoscopic and/or biliary drainage is planned;
  • Affiliation to, or beneficiary of, a social security scheme.

Exclusion criteria

Exclusion Criteria:

  • Woman who is pregnant or likely to become pregnant (without effective ) 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;
  • to an endoscopic procedure.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Portal vein blood sample

    Procedure: Blood sample in portal vein

Interventions

  • ProcedureBlood sample in portal vein

    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.

06

What researchers measure

Primary outcomes

  1. Procedure impact

    Rate of patients with a CTC increase \> 4 cells/ml in the portal system after the endoscopic procedure

    Time frame: 5 minutes after procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Nov 2024, 35 months after the start.

Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 35 months is below that.

Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2020
First posted
Dec 21, 2020
StartActual
Nov 11, 2021
Primary completionEst.
Nov 1, 2024
CompletionEst.
Nov 1, 2025
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04677244
Responsible party
Sponsor
First posted
Dec 21, 2020
Start date
Nov 11, 2021
Primary completion
Nov 1, 2024 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Apr 9, 2024

Study contacts

Dominique GENRE, MD
Contact
drci.up@ipc.unicancer.fr
+33491223778
Fabrice CAILLOL, MD
principal investigator · Paoli Calmettes Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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