Breast Cancer, Glycosidase Activity, Pancreatic Cancer, Probes, Pulmonary Cancer, Tumor Markers, Biological, Volatile Organic Compound
Conditions
Keywords
breast cancer, pancreatic cancer, pulmonary cancer, volatile organic compounds, glycosidase activity, localized cancer
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.
Interventions
BIOLOGICALblood plasma sample
For each patient, 5ml blood sample will be needed before the surgery and another 5ml blood sample one month after the surgery.
BIOLOGICALblood sampling
5ml blood sample for control arm
Sponsors
Poitiers University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
CONTACTSheik Emambux, MD PhD
Outcome results
None listed