Идёт набор NCT07236177

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.

Ранняя фаза I С лечением Breast Cancer Pancreatic Cancer Pulmonary Cancer Volatile Organic Compound

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: blood plasma sample, blood sampling.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Pancreatic Cancer, Pulmonary Cancer, Volatile Organic Compound. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Биопрепарат 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.
Биопрепарат blood sampling
5ml blood sample for control arm

Первичные конечные точки

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. [Срок оценки: before surgery and one month after surgery]

Вторичные конечные точки (5)

Compare the seven glycosidase levels in patients with localized breast cancer versus cancer-free control patients. [Срок оценки: one month]
Compare the seven glycosidase levels in patients with localized pancreatic cancer versus cancer-free control patients. [Срок оценки: one month]
Compare the seven glycosidase levels in patients with localized lung cancer versus cancer-free control patients. [Срок оценки: one month]
Compare the seven glycosidase levels according to cancer location (lung versus breast, pancreas versus breast, lung versus pancreas). [Срок оценки: one month]
Compare glycosidase levels in cancer patients before and after surgery (regardless of location: breast, lung, or pancreatic cancer). [Срок оценки: one month]

Критерии участия

Критерии включения

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.

Критерии исключения

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: