NCT03688347

Microbiome in Lung Cancer and Other Malignancies

The Role of Microbiome in Lung Cancer and Other Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Taher Abu Hejleh · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

Detailed description

Patients will be asked to provide nasal, oral and skin swabs, as well as stool samples during their regular clinic visits, at the baseline before desired therapy is given, and at the time when treatment is changed due to either disease progression or unbearable toxicities leading to treatment stop/change. If treatment stop/held is due to toxicities, a 3rd set of samples will be collected when toxicities reduce to less than grade 1. The samples will be subjected to DNA extraction followed by 16S rRNA and/or shotgun sequencing metagenomic analysis. The data will be correlated to clinical response from treatments, toxicities, clinical data (use of antibiotics, PPIs, lab parameters, etc.) and tissue genetic/immunological characteristics (mutations, PDL1 expression, etc.) for review of response. This is not data to be used for treatment of these subjects.

Conditions

• Lung Cancer
• Cancer
• Malignancy

Interventions

Type	Name	Description
PROCEDURE	Nasal Swab	The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.
PROCEDURE	Oral Swab	The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.
OTHER	Stool Collection	A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.
GENETIC	Microbiome analysis	Study of microbial communities found in and on the human body.
GENETIC	DNA Banking	Secure, long term storage of an individual's genetic material.
PROCEDURE	Skin Swab	Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.

Timeline

• Start date: 2018-08-30
• Primary completion: 2019-09-23
• Completion: 2022-05-09
• First posted: 2018-09-28
• Last updated: 2022-05-11

Locations

1 site across 1 country: United States