Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.


Criteria:

Inclusion Criteria: - Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC - Age 18 years old or older - Patient capable of giving informed consent Exclusion Criteria - Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration - Active infection with oral temperature >100°F - Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration - Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4). - Confirmed or suspected HIV, HBV or HCV - Chronic constipation (bowel movements less frequent than every other day) - Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated) - Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time - Patients on anti-diarrheal medications - Patients on probiotics


Study is Available At:


Original ID:

UPCC 15415


NCT ID:

NCT02559349


Secondary ID:


Study Acronym:


Brief Title:

Gut Microbiota And Radiotherapy


Official Title:

Gut Microbiota And Radiotherapy


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abramson Cancer Center of the University of Pennsylvania


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:Edgar Ben-Josef, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania

Study Dates

Start Date:September 2015
Completion Date:December 2019
Completion Type:Anticipated
Primary Completion Date:December 2019
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 15, 2019
First Received Date:September 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of subject providing stool samples
Time Frame:2 years
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Stool Collection

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Abramson Cancer Center of the University of Pennsylvania

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Stool Sample
Study Population: patients receiving SBRT to a lung tumor
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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