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| Name | Class |
|---|---|
| Holden Comprehensive Cancer Center | OTHER |
| Iowa Institute of Human Genetics | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate data from samples with patient clinical information | Correlate data from samples with patient clinical information regarding overall response rates. | 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 |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Taher Abu Hejleh, MBBS | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30183502 | Background | 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. | |
| 29781826 | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D015723 | Gene Library |
| ID | Term |
|---|---|
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
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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.
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. |
Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy. |
| Time of study enrollment up to one year |
| 34256732 | Derived | 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. |
| D012140 |
| Respiratory Tract Diseases |