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.

NCT07236177 | Recruiting Early Phase 1

• 1 other identifier: 2025-A01440-49
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

breast cancer; pancreatic cancer; pulmonary cancer; volatile organic compounds; glycosidase activity; localized cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  before surgery and one month after surgery

Secondary Outcomes (5)

• Compare the seven glycosidase levels in patients with localized breast cancer versus cancer-free control patients.

  one month

• Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients.

  one month

• Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients.

  one month

• Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas).

  one month

• Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer).

  one month

Study Arms (4)

breast cancer

ACTIVE COMPARATOR

Biological: blood plasma sample

pancreatic cancer

ACTIVE COMPARATOR

Biological: blood plasma sample

pulmonary cancer

ACTIVE COMPARATOR

Biological: blood plasma sample

no cancer

OTHER

no history of cancer

Biological: blood sampling

Interventions

blood plasma sample BIOLOGICAL

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

breast cancer; pancreatic cancer; pulmonary cancer

blood sampling BIOLOGICAL

5ml blood sample for control arm

no cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U. Poitiers

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sheik Emambux, MD PhD

CONTACT

+33549444279; sheik.emambux@chu-poitiers.mssante.fr

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: November 19, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 3, 2028
• Study Completion (Estimated): March 3, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)