Идёт набор NCT06307171

Human Leishmaniasis: Antigen Recognition Pattern and Study of New Potential Biomarkers

Без фазы С лечением Leishmaniasis

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: In-house Western blot, specific for Leishmania.
Кому может быть актуально: Состояния в реестре: Leishmaniasis. 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is an exploratory experimental multicentre study on archived serum samples and on prospectively collected serum samples and blood samples. General objectives of the study are: to identify specific biomarkers in order to develop more accurate serological tests for the screening of Leishmania infections that does not present cross-reaction with other infectious diseases; to unveil the Antigen Recognition Patterns (ARPs) of Leishmania infection in humans; to verify whether the ARPs and the new biomarkers are common to different Leishmania infantum strains isolated in Italy as well as in other part of the World and to different strains of L. donovani isolated in Sudan as well as in other part of the World and discard any possible cross reaction with other infectious diseases such as Chagas, TB, leprosy or malaria.

Вмешательства

Диагностический тест In-house Western blot, specific for Leishmania
Sample will be collected at the collaborating centres and at the DITM, if not already stored at -80°C. The samples will be delivered to the DITM. For the CONTROL groups, two serological tests for Leishmaniasis, based on different antigenic fraction, will be performed on serum samples. Different strains of Leishmania infantum and Leishmania donovani will be cultivated axenically at the DITM. Whole soluble fraction of promastigote (WSF), the whole membrane protein fraction (WMF) and the whole so

Первичные конечные точки

Biomarkers from Leishmania spp [Срок оценки: Baseline]

Вторичные конечные точки (2)

ARPs in different Leishmania infantum and L. donovani strains [Срок оценки: Baseline]
Cross reaction [Срок оценки: Baseline]

Критерии участия

CASES:

Критерии включения

Leishmania positive patient from Italy (n=30) and from Sudan (n=30);
patient with a clinically or laboratory confirmed diagnosis of leishmaniasis;
signed informed consent (criteria not applied in case of samples stored at the Tropica Biobank at the DITM)
being clinically classified as leishmaniasis patient by an experienced clinician or being laboratory confirmed as leishmaniasis patients, giving positive to at least two different serological tests or to a molecular test for Leishmania sp.
adult subjects (equal or older than 18 years)

Критерии исключения

lack of the necessary data and/or of biological samples
subjects younger than 18 years

COMMUNITY CONTROLS:

Критерии включения

Cryo-preserved serum samples stored at the Tropica Biobank at the DITM , IRCCS Sacro Cuore Don Calabria Hospital, Negrar (Vr), from subject from Italy (n=30) and from Africa (n=30) with no infection due by Leishmania spp.
signed informed consent to Tropica Biobank
adult subjects (equal or older than 18 years)
being negative to two different serological tests for leishmaniasis

Критерии исключения

subjects younger than 18 years
being positive to one serological tests for leishmaniasis.

VALIDATION CONTROLS (VC):

Критерии включения

serum samples stored in Tropica Biobank at the DITM from subjects that have been clinically diagnosed with Chagas's disease, or TB, or malaria or leprosy.
informed consent signed to Tropical Biobank
adult subjects (equal or older than 18 years)
being negative to two different serological tests for leishmaniasis.
being clinically diagnosed with Chagas disease or TB, or malaria or leprosy