Establishment of the Human Intestinal and Salivary Microbiota Biobank - Oncologic Diseases

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with non-small-cell lung cancer (NSCLC) and metastatic melanoma. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological) The study will allow to: * Provide biological samples (faeces, saliva, blood, urine) from oncologic patients to the first Italian microbiota biobank; * Study microorganisms using different in vitro and in vivo techniques; * Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01\_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

PATIENTS WITH NSLSC

* NSLSC diagnosis
* aged between 18 and 75 years
* omnivorous diet
* having suspended antibiotic therapy for at least 15 days
* cessation of treatment with cortisone for at least 15 days
* signature of the informed consent

PATIENTS WITH METASTATIC MELANOMA

* metastatic melanoma diagnosis
* aged between 18 and 75 years
* omnivorous diet
* having suspended antibiotic therapy for at least 15 days
* cessation of treatment with cortisone for at least 15 days
* signature of the informed consent

Exclusion Criteria:

PATIENTS WITH NSLSC/METASTATIC MELANOMA

Exclusion criteria:

* Current treatment with antibiotics or immunosuppressive drugs Previous chemotherapy treatmment Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
* Chronic liver disease
* History of Clostridium difficile infections
* Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
* Chronic therapy with proton pump inhibitors
* Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
* Previous history of organ / tissue transplantation
* Recent onset of diarrhea
* Chronic diarrhea
* Chronic constipation
* Previous gastrointestinal surgery (eg gastric bypass)
* Recurring urinary tract infections (3 cases per year)
* Previous major acute cardiovascular diseases (myocardial infarction, stroke)
* Type 2 diabetes mellitus
* Hypertension
* eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
* Chronic gastrointestinal disorders
* Systemic inflammatory diseases
* Autoimmune disorders or history of chronic and systemic autoimmune disorders
* Neurodegenerative disorders
* Pregnancy and breastfeeding
* Psychiatric conditions that reduce protocol compliance.

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