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.

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Cancer patients undergoing oncological treatment.

Cancer not proven by anatomopathological examination.

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood plasma sample

    Biological/Vaccine

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

  • blood sampling

    Biological/Vaccine

    5ml blood sample for control arm

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: breast cancerActive comparator 1 intervention
Group B: pancreatic cancerActive comparator 1 intervention
Group C: pulmonary cancerActive comparator 1 intervention
Group D: no cancerOther 1 intervention

Trial outcomes

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.

Time frame
before surgery and one month after surgery

Secondary outcomes

1

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

Time frame
one month
2

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

Time frame
one month
3

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

Time frame
one month
4

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

Time frame
one month

Other outcomes

Sponsors and contacts

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