RECRUITING

A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.

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

The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.

Official Title

A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.

Quick Facts

Study Start:2024-05-14
Study Completion:2027-05-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06635954

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 2. Stage III or IV cancer
  3. 3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice.
  4. 4. ECOG performance status ≤ 2
  5. 5. Clinically eligible for ICI therapy
  6. 6. Able to read, understand and provide written informed consent.
  7. 7. Willing and able to comply with the study requirements
  1. 1. Pregnant or breastfeeding
  2. 2. History of bone marrow or organ transplant
  3. 3. Contra indication for receiving Immune Check Point inhibitor.

Contacts and Locations

Study Contact

Ryan Mathis, MD
CONTACT
888-200-3361
ryan.mathis@myobdx.com
Joseph DeSimone, BA
CONTACT
803-329-7772
joseph@ccorn.net

Principal Investigator

Ryan Mathis, MD
STUDY_DIRECTOR
Oxford BioDynamics

Study Locations (Sites)

Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, 06360
United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
United States

Collaborators and Investigators

Sponsor: Oxford Biodynamics Inc.

  • Ryan Mathis, MD, STUDY_DIRECTOR, Oxford BioDynamics

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 Date2024-05-14
Study Completion Date2027-05-14

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2027-05-14

Terms related to this study

Keywords Provided by Researchers

  • immunotherapy
  • immune checkpoint inhibitor
  • ICI therapy
  • ICI
  • Immune Checkpoint Inhibitor therapy
  • Episwitch
  • Episwitch CiRT
  • Immune Related Adverse Event
  • IRAE
  • cancer
  • PD-1
  • PD-L1

Additional Relevant MeSH Terms

  • Cancer
  • Immunotherapy
  • PD-1
  • PD-L1
  • Immune Checkpoint Therapy