---
title: Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level
nct_id: NCT04677244
overall_status: UNKNOWN
phase: NA
sponsor: Institut Paoli-Calmettes
study_type: INTERVENTIONAL
primary_condition: Cancer of Pancreas
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04677244.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04677244"
ct_last_update_post_date: 2024-04-09
last_seen_at: "2026-05-12T07:22:39.217Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level

**Official Title:** Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care

**NCT ID:** [NCT04677244](https://clinicaltrials.gov/study/NCT04677244)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 42
- **Lead Sponsor:** Institut Paoli-Calmettes
- **Conditions:** Cancer of Pancreas
- **Start Date:** 2021-11-11
- **Completion Date:** 2025-11-01
- **CT.gov Last Update:** 2024-04-09

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **Portal vein blood sample** (EXPERIMENTAL)

## Interventions

- **Blood sample in portal vein** (PROCEDURE) — 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.

## Primary Outcomes

- **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

## Locations (1)

- Institut Paoli Calmettes, Marseille, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `locations.institut paoli calmettes|marseille||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04677244.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04677244*  
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