B-GLUCANCER2 : A Pilot Study Evaluating a New Method for Cancer Detection by Measuring the Activity of Different Glycosidase Enzymes in the Plasma of Patients With a Localized Cancer. (B-GLUCANCER2)

February 4, 2026 updated by: Poitiers University Hospital

Evaluation of a New Method for Detecting Cancer Pathologies by Measuring the Activity of Different Glycosidases in Plasma in Patients With Localized Cancer - Pilot Study: B-GLUCANCER2

The goal of this clinical trial is to develop a new cancer diagnostic and prognostic tool based on the dynamic and non-invasive detection of an exogenous volatile molecule, i.e., ethanol, from patients' samples.

Patients' blood plasma will be analyzed with a mixture of volatile organic compound-based probes, each targeting a specific glycosidase. The presence of a given glycosidase in a blood sample would thus be revealed by the detection of an ethanol isotope in the gas phase.

3 groups of patients with localized cancer (breast, prostate, pancreas) will be enrolled, as well as 1 group of patient without any cancer (control group).

For the patients, two 5ml plasma samples will be collected, one before and one after surgery for localized cancers. For healthy volunteers, only one 5ml plasma sample will be collected.

The primary objective will be to compare the levels of glycosidases measured in the blood of patients followed for localized cancer and referred for first surgery compared to control patients without cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Early Phase 1

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 Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Group 1: 40 patients with definitively diagnosed, untreated, localized solid breast cancer referred for initial surgical treatment.

Group 2: 40 patients with definitively diagnosed, untreated, localized solid lung cancer referred for initial surgical treatment.

Group 3: 40 patients with definitively diagnosed, untreated, localized solid pancreatic cancer referred for initial surgical treatment.

Group 4: 100 control patients with no cancer diagnosis or history of solid or hematological cancer.

Exclusion Criteria:

  • Refusal to participate in the research.
  • Patients benefiting from enhanced protection, namely: minors, pregnant/breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a social care facility, adults under legal protection

Specific criteria for groups 1, 2, and 3:

  • Cancer patients undergoing oncological treatment.
  • Cancer not proven by anatomopathological examination.

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: breast cancer
Biological: blood plasma sample
For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.
Active Comparator: pancreatic cancer
Biological: blood plasma sample
For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.
Active Comparator: pulmonary cancer
Biological: blood plasma sample
For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.
Other: no cancer
no history of cancer
Biological: blood sampling
5ml blood sample for control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the levels of glycosidases measured in the blood samples of patients treated for a localized cancer (breast, lung or pancreatic cancer) compared to control patients without cancer.
Time Frame: before surgery and one month after surgery
before surgery and one month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the seven glycosidase levels in patients with localized breast cancer versus cancer-free control patients.
Time Frame: one month
one month
Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients.
Time Frame: one month
one month
Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients.
Time Frame: one month
one month
Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas).
Time Frame: one month
one month
Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer).
Time Frame: one month
one month

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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)

February 3, 2026

Primary Completion (Estimated)

February 3, 2028

Study Completion (Estimated)

March 3, 2028

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01440-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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