Breast CancerEarly Phase 1B-GLUCANCER2NCT07236177
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.
A Early Phase 1 study testing blood plasma sample and blood sampling in people with Breast Cancer and Pancreatic Cancer, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Pancreatic Cancer, Pulmonary Cancer
- What is being tested?
- blood plasma sample and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2026to 3 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
C.H.U. Poitiers
Poitiers, 86000
Sheik EMAMBUX, MD, +33549444279, sheik.emambux@chu-poitiers.fr
About this study
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
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.
Read more
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
- Being tested
- blood plasma sample, blood sampling
- Keywords
- breast cancer, pancreatic cancer, pulmonary cancer, volatile organic compounds, glycosidase activity, localized cancer
- Medical subject headings
- Breast Neoplasms, Pancreatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood plasma sampleBiological
For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.
blood samplingBiological
5ml blood sample for control arm
| Study group | Role | What they receive |
|---|---|---|
| breast cancer | Active comparator | Not described Receives: Biological: blood plasma sample |
| pancreatic cancer | Active comparator | Not described Receives: Biological: blood plasma sample |
| pulmonary cancer | Active comparator | Not described Receives: Biological: blood plasma sample |
| no cancer | Other | no history of cancer Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one month
Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients.
Measured: one month
Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients.
Measured: one month
Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas).
Measured: one month
Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start3 Feb 2026
- Primary completion3 Feb 2028 (estimated)
- Study completion3 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236177
- Sponsor's protocol ID
- 2025-A01440-49
- Acronym
- B-GLUCANCER2
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07236177
- Acronym / sponsor ID
- B-GLUCANCER2 / 2025-A01440-49
- Conditions
- Breast Cancer, Pancreatic Cancer, Pulmonary Cancer, Volatile Organic Compound, Glycosidase Activity, Probes
- Keywords
- breast cancer, pancreatic cancer, pulmonary cancer, volatile organic compounds, glycosidase activity, localized cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 3 Feb 2028 (estimated)
- Study completion
- 3 Mar 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: blood samplingno history of cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood plasma sampleFor each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery. | Biological | breast cancer, pancreatic cancer, pulmonary cancer |
| blood sampling5ml blood sample for control arm | Biological | no cancer |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing blood plasma sample and blood sampling in people with Breast Cancer and Pancreatic Cancer, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheik Emambux, MD PhD (+33549444279, sheik.emambux@chu-poitiers.mssante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.