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

NCT04698161 | Completed

• 1 other identifier: BIOMIS-Onco
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; Metastatic Melanoma

Keywords

Microbioma biobank; Biological human samples; Oncologic diseases; Meta-omics approaches; Microbiota-pathology relationship

Outcome Measures

Primary Outcomes (1)

• Biological samples collection for establishment of the first National Microbiome Biobank

  Recruitment of 50 subjects (non-small-cell lung cancer and metastatic melanoma patients) to collect biological samples for establishment of the first National Microbiome Biobank

  through study completion, an average of 1 year

Study Arms (2)

NSCLC

Patients with non-small-cell lung cancer (NSCLC)

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

metastatic melanoma

patients with metastatic melanoma

Other: Biological sample collection; Other: Questionnaire; Other: Medical examination

Interventions

Biological sample collection OTHER

Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria

NSCLC; metastatic melanoma

Questionnaire OTHER

Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire

NSCLC; metastatic melanoma

Medical examination OTHER

Blood pressure measurement, abdominal and thoracic physical examination

NSCLC; metastatic melanoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with non-small-cell lung cancer (NSCLC) and metastatic melanoma attending the IRCSS Istituto Tumori di Bari. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.

You may qualify if:

• 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

You may not qualify if:

• PATIENTS WITH NSLSC/METASTATIC MELANOMA
• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead
• Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies: collaborator
• Istituti Tumori Giovanni Paolo II: collaborator
• University of Bari Aldo Moro: collaborator
• University of Salento: collaborator

Study Sites (1)

IRCCS Istituto Tumori Giovanni Paolo II

Bari, Italy

Location

Related Publications (5)

• Bingula R, Filaire M, Radosevic-Robin N, Berthon JY, Bernalier-Donadille A, Vasson MP, Thivat E, Kwiatkowski F, Filaire E. Characterisation of gut, lung, and upper airways microbiota in patients with non-small cell lung carcinoma: Study protocol for case-control observational trial. Medicine (Baltimore). 2018 Dec;97(50):e13676. doi: 10.1097/MD.0000000000013676.

  PMID: 30558074 BACKGROUND

• Matson V, Fessler J, Bao R, Chongsuwat T, Zha Y, Alegre ML, Luke JJ, Gajewski TF. The commensal microbiome is associated with anti-PD-1 efficacy in metastatic melanoma patients. Science. 2018 Jan 5;359(6371):104-108. doi: 10.1126/science.aao3290.

  PMID: 29302014 BACKGROUND

• Frankel AE, Coughlin LA, Kim J, Froehlich TW, Xie Y, Frenkel EP, Koh AY. Metagenomic Shotgun Sequencing and Unbiased Metabolomic Profiling Identify Specific Human Gut Microbiota and Metabolites Associated with Immune Checkpoint Therapy Efficacy in Melanoma Patients. Neoplasia. 2017 Oct;19(10):848-855. doi: 10.1016/j.neo.2017.08.004. Epub 2017 Sep 15.

  PMID: 28923537 BACKGROUND

• Chaput N, Lepage P, Coutzac C, Soularue E, Le Roux K, Monot C, Boselli L, Routier E, Cassard L, Collins M, Vaysse T, Marthey L, Eggermont A, Asvatourian V, Lanoy E, Mateus C, Robert C, Carbonnel F. Baseline gut microbiota predicts clinical response and colitis in metastatic melanoma patients treated with ipilimumab. Ann Oncol. 2017 Jun 1;28(6):1368-1379. doi: 10.1093/annonc/mdx108.

  PMID: 28368458 BACKGROUND

• Dubin K, Callahan MK, Ren B, Khanin R, Viale A, Ling L, No D, Gobourne A, Littmann E, Huttenhower C, Pamer EG, Wolchok JD. Intestinal microbiome analyses identify melanoma patients at risk for checkpoint-blockade-induced colitis. Nat Commun. 2016 Feb 2;7:10391. doi: 10.1038/ncomms10391.

  PMID: 26837003 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

faeces, saliva, blood, serum, urine, PBMC

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma

Interventions

Surveys and Questionnaires; Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Angelo V Paradiso, MD

  IRCCS Istituto Tumori Giovanni Paolo II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: January 6, 2021
• Study Start: February 25, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)