An observational study in Lung Cancer, Cancer and Malignancy, sponsored by Taher Abu Hejleh. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Taher Abu Hejleh · Observational
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,555 are open to participants now.
This study's enrollment of 44 is below the median of 190 across 1,548 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with Taher Abu Hejleh as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
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.
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.
Study of microbial communities found in and on the human body.
Secure, long term storage of an individual's genetic material.
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
Bacterial DNA will be isolated from stool/swab samples using standard protocol. Fecal micobiota will be examined based on an 16S rRNA amplicon.
Time frame: Time of study enrollment up to one year
Correlate data from samples with patient clinical information
Correlate data from samples with patient clinical information regarding overall response rates.
Time frame: 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
Record from each clinical visit the AEs from immunotherapy or its combination with chemotherapy.
Time frame: Time of study enrollment up to one year
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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