NCT04698161: BIOMIS-Onco

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

Completed Last updated 4 August 2022

What this trial tests

trial testing Biological sample collection in Non Small Cell Lung Cancer in 50 participants. Completed in 11 July 2022.

Timeline

25 February 2021

Primary endpoint
11 July 2022

11 July 2022

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	25 February 2021
Primary completion	11 July 2022
Estimated completion	11 July 2022
Sites	1 location across Italy

Drugs / interventions tested

• Biological sample collection — full drug profile →
• Questionnaire
• Medical examination

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Who can join

Adults 18 to 75, any sex, with Non Small Cell Lung Cancer or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255
2. A narrative review from gut to lungs: non-small cell lung cancer and the gastrointestinal microbiome.
   Shah H, Ng TL. · · 2023 · cited 17× · PMID 37197624 · DOI 10.21037/tlcr-22-595
3. The cure from within? a review of the microbiome and diet in melanoma.
   Kumar P, Brazel D, DeRogatis J, Valerin JBG, et al · · 2022 · cited 17× · PMID 35474500 · DOI 10.1007/s10555-022-10029-3
4. Microbial Influences on Immune Checkpoint Inhibitor Response in Melanoma: The Interplay between Skin and Gut Microbiota.
   Bouferraa Y, Fares C, Bou Zerdan M, Boyce Kennedy L. · · 2023 · cited 12× · PMID 37298653 · DOI 10.3390/ijms24119702
5. Gut microbiota and metabolites: emerging prospects in the treatment of non-small cell lung cancer.
   Jiao JM, Liu CG, Zang D, Chen J. · · 2025 · PMID 41268538 · DOI 10.3389/fimmu.2025.1638942