Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps (EARDIS)

February 6, 2026 updated by: Centre Hospitalier Universitaire de Nīmes
The study authors hypothesize that in patients with intestinal polyps, tumor cells could disseminate and circulating factors could be secreted by the polyp. These two parameters could become biomarkers to refine the follow-up of patients and to establish targeted therapeutic strategies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nîmes, France
        • CHU de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for colonoscopy in the Hepato-Gastro-Enterology Department of the University Hospital of Nîmes. Patients with a family history of colorectal cancer and aged over 50 years, with a positive Fecal Immunological Test, with bleeding, with abdominal pain or with unexplained anemia are all likely to undergo colonoscopy

Description

Inclusion Criteria:

  • Patient to be examined by colonoscopy
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject signals their opposition to participate in the study
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient pregnant or breastfeeding
  • History of proven cancerous disease
  • Patient followed for a chronic inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with polyps
Other: Blood test
Venous blood samples taken at the moment of colonoscopy to test for biomarkers
Patients without polyps
Other: Blood test
Venous blood samples taken at the moment of colonoscopy to test for biomarkers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
Time Frame: Day 0
Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups
Time Frame: Day 0
ng/mL, measured by Enzyme-Linked ImmunoSorbent Assay
Day 0
Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Yes/no
Day 0
Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Yes/no
Day 0
Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Yes/no
Day 0
Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Fecal immunochemical test positive / Personal history of colonic adenoma / Family history of colonic adenoma / Personal history of colorectal cancer / Family history of colorectal cancer / Rectal symptoms
Day 0
Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Day 0
Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Boston classification: ranked from 0 to 3 for each colonic segment explored
Day 0
Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
classed as complete colonoscopy after visualization of the caecal floor
Day 0
Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Post-polypectomy bleeding / Perforation / Incomplete colonoscopy / No complications
Day 0
Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Number
Day 0
Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Number
Day 0
Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
< 5mm / 5 - 10mm / > 10mm
Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Day 0
Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Paris classification: 0-Is / 0-Ip / 0-IIa / 0-IIb / 0-IIc / 0-III
Day 0
Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Biopsy forceps / Cold loop / Diathermic loop / Mucosectomy / Unresected (Suspected Cancer, Unresectable in ambulatory)
Day 0
Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Yes/no
Day 0
Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp
Time Frame: Day 0
Vienna classification: Nonspecific (Food Residue, Normal Mucosa or Colonic Fold) / Adenoma in Low Grade Dysplasia / Adenoma in High Grade Dysplasia / Cancer - Transformed Adenoma / Scalloped Adenoma / Hyperplastic Polyp.
Day 0
Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression
Time Frame: Day 0
Rectum / Sigmoid / Left Colon / Transverse Colon / Right Colon / Caecum
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-François BOURGAUX, CHU de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2022-1/JFB01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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