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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood plasma sample, blood sampling.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Pancreatic Cancer, Pulmonary Cancer, Volatile Organic Compound. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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. - Biological blood sampling
5ml blood sample for control arm
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Compare the seven glycosidase levels in patients with localized breast cancer versus cancer-free control patients. [Time frame: one month]
- Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients. [Time frame: one month]
- Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients. [Time frame: one month]
- Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas). [Time frame: one month]
- Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer). [Time frame: one month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- C.H.U. Poitiers — Poitiers
Identifiers
NCT: NCT07236177 · 2025-A01440-49