Microbiome in Lung Cancer and Other Malignancies

NCT03688347 | Completed

• 1 other identifier: 201712819
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer; Cancer; Malignancy

Outcome Measures

Primary Outcomes (1)

• Identify and compare bacteria within given samples through standard protocol and 16S rRNA amplicon

  Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.

  Time of study enrollment up to one year

Secondary Outcomes (2)

• Correlate data from samples with patient clinical information

  Time of study enrollment up to one year

• Number of treatment related adverse events (AE) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  Time of study enrollment up to one year

Interventions

Nasal Swab PROCEDURE

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.

Oral Swab PROCEDURE

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.

Stool Collection OTHER

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.

Microbiome analysis GENETIC

Study of microbial communities found in and on the human body.

DNA Banking GENETIC

Secure, long term storage of an individual's genetic material.

Skin Swab PROCEDURE

Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All individuals, meeting eligibility requirements will be eligible to participate in the study by providing samples during times of routine care for lung cancer and other malignancies.

You may qualify if:

• Patients diagnosed with lung cancer and other malignancies who are candidates for systemic therapies such as immunotherapy and chemotherapy
• Eligibility criteria for studying microbiome in patients receiving immunotherapy:
• Patients with advanced/recurrent lung cancer (including both NSCLC and SCLC) and other solid tumors of our study interest (e.g. GU cancer and melanoma, etc.) that initiate a new line of immunotherapy (can be 1st or later line), either alone or in combination with chemotherapy, targeted therapy or other immunotherapy.
• Patients can be in other clinical trials as long as they meet criteria 1.
• Prior treatment with immunotherapy is acceptable as long as criteria 1 is met. For example, a new line therapy with pembrolizumab plus pemetrexed after failing pembrolizumab is considered eligible.
• Patients who are to start immunotherapy maintenance after chemoradiation therapy are eligible (e.g. NSCLC patients who will be on durvalumab maintenance)
• Patients who are to start immunotherapy after local therapies (e.g. radiation, ablation, etc.) are eligible.
• Immunotherapy must have component of anti-PD-1/PD-L1 agents (e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab and avelumab, etc.) or anti-CTLA4 (e.g. ipilimumab)

You may not qualify if:

• Patients \< 18 years of age
• Patients that are pregnant
• Patients taking more than 2 alcoholic drinks per day and those using non-medical drugs such as marijuana, cocaine, heroine, etc.

Sponsors & Collaborators

• Taher Abu Hejleh: lead
• Holden Comprehensive Cancer Center: collaborator
• Iowa Institute of Human Genetics: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (3)

• Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.

  PMID: 30183502 BACKGROUND

• Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.

  PMID: 29781826 BACKGROUND

• Chau J, Yadav M, Liu B, Furqan M, Dai Q, Shahi S, Gupta A, Mercer KN, Eastman E, Hejleh TA, Chan C, Weiner GJ, Cherwin C, Lee STM, Zhong C, Mangalam A, Zhang J. Prospective correlation between the patient microbiome with response to and development of immune-mediated adverse effects to immunotherapy in lung cancer. BMC Cancer. 2021 Jul 13;21(1):808. doi: 10.1186/s12885-021-08530-z.

  PMID: 34256732 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA will be isolated from oral, skin, and nasal swabs, as well as stool samples. The extracted DNA will be subsequently used for microbiome analysis.

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Gene Library

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genetic Structures; Genetic Phenomena

Study Officials

• Taher Abu Hejleh, MBBS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: August 30, 2018
• Primary Completion: September 23, 2019
• Study Completion: May 9, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)