ACTIVE_NOT_RECRUITING

Project REMOTE (REimagining Measurements and Operations of Translational Endpoints)

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

This trial is designed to assess immunological biomarkers measured from blood samples that can be used to reliably predict how well vaccines work against symptomatic COVID-19 as well as to evaluate the feasibility of remote, self-collected specimens when conducting a correlates analysis. For a lot of research studies, people need to go to the study doctor's office regularly. For this study, we want to see if it is okay that people do the study doctor visits virtually, fill out questionnaires electronically, and collect their own samples remotely. Participants will enroll in the study after receiving a COVID-19 vaccine in their community, and saliva and blood specimens will be collected at pre-defined time-points over a 12-month period. Additionally, participants will report weekly whether they experience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab for testing. Most participants will complete all activities remotely and via electronic communications, but a small number will complete activities in person at the doctor's office to provide a comparison group. Samples from the study will be analyzed to determine whether the biomarkers can be measured, and data from the study will be used to evaluate the feasibility of doing the specimen and data collection without the participant going to the doctor's office in person.

Official Title

Longitudinal Assessment of Potential Immunologic Correlates of Risk and Protection Following COVID-19 Vaccination Comparing Remote and Site-based Specimen Collection (Feasibility, Validity, and Proof of Concept)

Quick Facts

Study Start:2024-12-20
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06776367

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are willing and able to provide voluntary electronic informed consent (eConsent) to participate in the study and written authorization (via electronic signature) for use and disclosure of protected health information
  2. * Are able to understand and comply with planned study procedures, including specimen collection devices, use of eCOA application on a tablet or smartphone, and the wearable biometric device.
  3. * Are ≥18 years old at time of informed consent
  4. * Are available for all study data collection timepoints
  5. * Completed primary approved/authorized COVID-19 vaccination series, defined as previous receipt of one of the following options:
  6. * Doses of original monovalent mRNA or bivalent mRNA vaccine or a combination of the two,
  7. * Doses of original monovalent Novavax COVID-19 Vaccine, alone or in combination with any mRNA vaccine doses; or
  8. * Doses of Janssen COVID-19 Vaccine, alone or in combination with any mRNA or Original monovalent Novavax vaccine doses.
  9. * Receipt of an FDA licensed/authorized COVID-19 vaccine within the previous 14 days or on the day of enrollment
  1. * Receipt or planned receipt of any of the following vaccines, on the same day or within 28 days prior to or after receipt of the FDA licensed/authorized COVID-19 vaccine:
  2. * Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
  3. * Receipt of COVID-19 vaccine within 120 days prior to current vaccine
  4. * Any disease or medical condition that, in the opinion of the Investigator or appropriate sub-investigator, is a contraindication to study participation
  5. * Pregnant individuals (only exclusionary for the peripheral blood mononuclear cells \[PBMCs\] blood draws portion of the study)
  6. * Currently participating or plans to participate in another clinical trial that is interventional and/or involving an investigational product.
  7. * Are assessed by the Investigator as unsuitable for participation in this study for any reason.

Contacts and Locations

Study Locations (Sites)

Accel Research Site Networks - Birmingham CRU / Elite
Vestavia Hills, Alabama, 35216
United States
Desert Clinical Research
Mesa, Arizona, 85213
United States
Apex Research Group
Fair Oaks, California, 95628
United States
Wake Research Encino
Los Angeles, California, 91316
United States
Wake Research San Diego
San Diego, California, 92111
United States
Research Institute of South Florida
Miami, Florida, 33173
United States
Emory University
Atlanta, Georgia, 30322
United States
Wake Research Atlanta
Atlanta, Georgia, 30328
United States
Johnson County Clinical Trials (JCCT)
Lenexa, Kansas, 66219
United States
Research Integrity / WCG
Owensboro, Kentucky, 42303
United States
Alcanza / hyperCORE
Boston, Massachusetts, 02131
United States
Be Well Clinical Studies / Elite
Lincoln, Nebraska, 68516
United States
SUNY / Upstate Medical University Global Health Institute
Syracuse, New York, 13057
United States
Kroger The Little Clinic (Remote Site)
Blue Ash, Ohio, 45242
United States
Lynn Health Science Institute East / Elite
Oklahoma City, Oklahoma, 73112
United States
Wake Research Dallas
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Biomedical Advanced Research and Development Authority

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 Date2024-12-20
Study Completion Date2026-07

Study Record Updates

Study Start Date2024-12-20
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • COVID-19
  • Pandemic Preparedness
  • COVID-19 vaccine
  • immune correlates
  • self-collected
  • feasibility

Additional Relevant MeSH Terms

  • COVID-19