Microbiome in Lung Cancer and Other Malignancies

NCT ID: NCT03688347

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-30
• Study Completion Date: 2022-05-09

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.

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Microbiome analysis

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

Intervention Type: GENETIC

DNA Banking

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

Intervention Type: GENETIC

Skin Swab

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holden Comprehensive Cancer Center

OTHER

Sponsor Role: collaborator

Iowa Institute of Human Genetics

UNKNOWN

Sponsor Role: collaborator

Taher Abu Hejleh

OTHER

Sponsor Role: lead

Responsible Party

Taher Abu Hejleh

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Taher Abu Hejleh, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30183502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29781826 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34256732 (View on PubMed)

Other Identifiers

201712819

Identifier Type: -

Identifier Source: org_study_id