Microbiome in Lung Cancer and Other Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03688347|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : May 15, 2019
|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|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|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|
- 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.
- 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.
- 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.
- 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
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
|Contact: Jun Zhang, MD, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Jun Zhang, MD, PhD|
|Principal Investigator:||Jun Zhang, MD, PhD||University of Iowa|