A Study to Evaluate Whether Probiotics for Gut Microbiome Will Target Cancer Immune Microenvironment in Breast and Lung Cancer
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-011177
NCT ID: NCT04857697
Sponsor Protocol Number: MC210302
About this study
The purpose of this study is to evaluate whether engineering gut microbiome using probiotics will alter host immunological response to breast and lung cancers.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Males or females ≥ 18 years of age.
- Patients with operable breast or lung cancer with tumors ≥ 1cm (according to imaging) prior to surgery not requiring neoadjuvant therapy.
- Histologically confirmed adenocarcinoma of the breast operable stage I-III or histologically confirmed carcinoma of the lung operable stage I-III will be enrolled prior to their definitive surgery.
- Patients must have adequate organ function, not receive systemic neoadjuvant therapy, and be willing to provide tissue, blood, and stool samples for research study.
- Patients must not have taken any probiotics in the past 30 days prior to the enrollment.
Exclusion Criteria:
- Patients < 18 years of age.
- Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician’s discretion will be excluded.
Eligibility last updated 1/12/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Saranya Chumsri, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available