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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast cancer | Active Comparator |
| |
| pancreatic cancer | Active Comparator |
| |
| pulmonary cancer | Active Comparator |
| |
| no cancer | Other | no history of cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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:
Specific criteria for groups 1, 2, and 3:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheik Emambux, MD PhD | Contact | +33549444279 | sheik.emambux@chu-poitiers.mssante.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.U. Poitiers | Recruiting | Poitiers | 86000 | France |
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| blood sampling | Biological | 5ml blood sample for control arm |
|
| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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