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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— GEODE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03477474
• Other study ID #: 01-MX-003
• Status: Terminated
• Start date: April 6, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: Guardant Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 311
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

General 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:

1. 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer Metastatic

Locations

Country	Name	City	State
United States	Holy Cross	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Guardant Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate Progression Free Survival (PFS)		24 Months
Secondary	Duration of treatment response		24 Months
Secondary	Time of tumor progression		24 Months
Secondary	time to treatment failure		24 Months
Secondary	Overall survival		24 Months
Secondary	Turnaround time for Guardant360 and tissue based genomic testing		24 Months
Secondary	Molecular alteration discovery rates for various alterations		24 Months
Secondary	Tumor response rates		24 Months
Secondary	Quantity not sufficient rescue rates		24 Months
Secondary	Tissue incomplete rescue rate		24 Months
Secondary	The rate at which treatment plans are changed following results of the Guardant360 test		24 Months