Registry of Guardant360® Use and Outcomes In People With Advanced Cancer

Terminated

• Conditions: Non-small Cell Lung Cancer Metastatic

• Registration Number: NCT03477474
• Lead Sponsor: Guardant Health, Inc.

Brief Summary

The purpose of this registry is to collect data that describes the characteristics of people with advanced cancer for whom the Guardant360 assay is ordered and to observe their clinical outcomes after receiving their results.

Detailed Description

This is a prospective, descriptive registry of people with advanced cancer for whom a Guardant360 assay has been ordered by their health care providers. The registry is divided into modules according to primary cancer diagnosis. Module 1 includes subjects with advanced NSCLC with additional modules added later in the study.

All eligible people for whom blood for a Guardant360 assay has been collected will be invited to participate in the registry. Subject demographics and relevant medical history will be collected at the time of enrollment. Information on tumor molecular testing, treatment decisions, and clinical outcomes from the time of enrollment will be collected in a prospective manner. The registry does not require any specific treatments or procedures but rather collects information on the treatment journey of each participant. Subjects may participate in other clinical studies while also participating in GEODE.

Study Timeline

• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-26
• Study Start: 2018-04-06
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

1. 18 Years of age or older
2. Ability to provide written informed consent
3. Blood collected for the most recent Guardant360 test within 8 weeks prior to enrollment

General Exclusion Criteria

1. Pregnancy at the time of the qualifying Guardant360 blood collection
2. History of the allogeneic organ or tissue transplant

Module 1 (Non-Small Cell Lung Cancer)

Inclusion Criteria

1. NSCLC, confirmed by histology or cytology

2. Advanced disease, defined as: stage IIIB or IV NSCLC at the time of the qualifying Guardant360 blood collection; or for subjects with an initial diagnosis of Stage I-IIIA disease, NSCLC that is recurrent or metastatic at the time of the qualifying Guardant360 blood collection

3. One of the following conditions at the time of the qualifying Guardant360 blood collection:

   • No prior systemic therapy for advanced disease OR
   • All three of the following conditions:

4. A history of prior systemic therapy for advanced disease, 2. Disease progression within the previous four weeks, & 3. No new systemic therapy for advanced disease

Exclusion Criteria Subjects with a diagnosis or history of any cancer involving the lung that is not classified as NSCLC, including but not limited to small cell carcinoma, neuroendocrine or carcinoid tumor, lymphoma, mesothelioma, metastatic non-lung carcinoma, or cancer of unknown primary.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate Progression Free Survival (PFS)	24 Months

Secondary Outcome Measures

Name	Time	Method
Duration of treatment response	24 Months
time to treatment failure	24 Months
Quantity not sufficient rescue rates	24 Months
Time of tumor progression	24 Months
Overall survival	24 Months
Turnaround time for Guardant360 and tissue based genomic testing	24 Months
Tumor response rates	24 Months
Tissue incomplete rescue rate	24 Months
Molecular alteration discovery rates for various alterations	24 Months
The rate at which treatment plans are changed following results of the Guardant360 test	24 Months

Trial Locations

Locations (1)

Holy Cross; 🇺🇸 Fort Lauderdale, Florida, United States