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.

NCT ID: NCT07236177

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Pancreatic Cancer Pulmonary Cancer Volatile Organic Compound Glycosidase Activity Probes Tumor Markers, Biological

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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breast cancer

Group Type ACTIVE_COMPARATOR

blood plasma sample

Intervention Type BIOLOGICAL

For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.

pancreatic cancer

Group Type ACTIVE_COMPARATOR

blood plasma sample

Intervention Type BIOLOGICAL

For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.

pulmonary cancer

Group Type ACTIVE_COMPARATOR

blood plasma sample

Intervention Type BIOLOGICAL

For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.

no cancer

no history of cancer

Group Type OTHER

blood sampling

Intervention Type BIOLOGICAL

5ml blood sample for control arm

Interventions

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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.

Intervention Type BIOLOGICAL

blood sampling

5ml blood sample for control arm

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sheik Emambux, MD PhD

Role: CONTACT

+33549444279

Other Identifiers

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2025-A01440-49

Identifier Type: -

Identifier Source: org_study_id

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