RECRUITING

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

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 SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.

Official Title

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Quick Facts

Study Start:2023-10-25
Study Completion:2029-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05935384

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * History of a prior solid or hematological malignancy within 5 years of enrollment
  2. * Life expectancy \< 12 weeks
  3. * Unable to collect baseline blood sample prior to starting SOC regimen
  4. * Is participating in an interventional clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

Contacts and Locations

Study Contact

Clinical Trial Operations
CONTACT
8556988887
sibyl@guardanthealth.com

Study Locations (Sites)

Orchard Healthcare Research Inc.
Skokie, Illinois, 60077-1384
United States

Collaborators and Investigators

Sponsor: Guardant Health, Inc.

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 Date2023-10-25
Study Completion Date2029-08-30

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2029-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Breast Cancer