RECRUITING

NextGen - Clinical Implication of Next Generation Sequencing

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Official Title

Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture

Quick Facts

Study Start:2022-05-17
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05206500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female at least 18 years of age
  2. * U/C (Urinary Culture) growth of \<10,000 Colony-Forming Units (CFU)
  3. * Understanding and acceptance of the need to return for all scheduled follow-up visits
  4. * Able to give informed consent
  1. * Catheter in use (Foley or suprapubic or intermittent)
  2. * Not able to provide clean midstream urine
  3. * Antibiotic consumption in the past 2 weeks before signing the consent
  4. * Pregnant or Planning to Conceive
  5. * Incarcerated

Contacts and Locations

Study Contact

Majid Mirzazadeh, MD
CONTACT
336-716-4310
mmirzaza@wakehealth.edu
Sachin N Vyas, MS, PhD
CONTACT
336-713-4098
svyas@wakehealth.ed

Principal Investigator

Majid Mirzazadeh, MD
PRINCIPAL_INVESTIGATOR
Wake Forest Health Sciences

Study Locations (Sites)

Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Majid Mirzazadeh, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-17
Study Completion Date2026-06

Study Record Updates

Study Start Date2022-05-17
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Tract Infections