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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.

P

Poitiers University Hospital

Status and phase

Enrolling
Early Phase 1

Conditions

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

Treatments

Biological: blood plasma sample
Biological: blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT07236177
2025-A01440-49

Details and patient eligibility

About

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.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 4 patient groups

breast cancer
Active Comparator group
Treatment:
Biological: blood plasma sample
pancreatic cancer
Active Comparator group
Treatment:
Biological: blood plasma sample
pulmonary cancer
Active Comparator group
Treatment:
Biological: blood plasma sample
no cancer
Other group
Description:
no history of cancer
Treatment:
Biological: blood sampling

Trial contacts and locations

1

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Central trial contact

Sheik Emambux, MD PhD

Data sourced from clinicaltrials.gov

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