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

NCT03477474 | Terminated

• 1 other identifier: 01-MX-003
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

Guardant Health

Outcome Measures

Primary Outcomes (1)

• Estimate Progression Free Survival (PFS)

  24 Months

Secondary Outcomes (10)

• Duration of treatment response

  24 Months

• Time of tumor progression

  24 Months

• time to treatment failure

  24 Months

• Overall survival

  24 Months

• Turnaround time for Guardant360 and tissue based genomic testing

  24 Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General Population Description: People With Advanced Cancer for whom the Guardant360 assay is ordered. Module 1 \[NSCLC\] Description: People with Advanced NSCLC for whom the Guardant360 assay is ordered.

You may qualify if:

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

You may not qualify if:

• Pregnancy at the time of the qualifying Guardant360 blood collection
• History of the allogeneic organ or tissue transplant
• Module 1 (Non-Small Cell Lung Cancer)
• NSCLC, confirmed by histology or cytology
• 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
• 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:
• \. 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

Sponsors & Collaborators

• Guardant Health, Inc.: lead

Study Sites (1)

Holy Cross

Fort Lauderdale, Florida, 33308, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 26, 2018
• Study Start: April 6, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

US (1)