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Microbiome in Lung Cancer and Other Malignancies

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ClinicalTrials.gov Identifier: NCT03688347
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Holden Comprehensive Cancer Center
Iowa Institute of Human Genetics
Information provided by (Responsible Party):
Jun Zhang, MD, PhD, University of Iowa

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.

Condition or disease Intervention/treatment
Lung Cancer Cancer Malignancy Procedure: Nasal Swab Procedure: Oral Swab Other: Stool Collection Genetic: Microbiome analysis Genetic: DNA Banking Procedure: Skin Swab

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Role of Microbiome in Lung Cancer and Other Malignancies
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Identify and compare bacteria within given samples through standard protocol and 16S rRNA amplicon [ Time Frame: Time of study enrollment up to one year ]
    Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.


Secondary Outcome Measures :
  1. Correlate data from samples with patient clinical information [ Time Frame: Time of study enrollment up to one year ]
    Correlate data from samples with patient clinical information regarding overall response rates.

  2. Number of treatment related adverse events (AE) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Time of study enrollment up to one year ]
    Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688347


Contacts
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Contact: Jun Zhang, MD, PhD 319-356-2148 jun-zhang-1@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jun Zhang, MD, PhD         
Sponsors and Collaborators
Jun Zhang, MD, PhD
Holden Comprehensive Cancer Center
Iowa Institute of Human Genetics
Investigators
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Principal Investigator: Jun Zhang, MD, PhD University of Iowa

Publications:
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Responsible Party: Jun Zhang, MD, PhD, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03688347     History of Changes
Other Study ID Numbers: 201712819
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases