Clinical trial NCT03477474: Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
Official title: Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: Guardant Health
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimate Progression Free Survival (PFS)
timeFrame: 24 Months
Secondary outcomes:
measure: Duration of treatment response
timeFrame: 24 Months
measure: Time of tumor progression
timeFrame: 24 Months
measure: time to treatment failure
timeFrame: 24 Months
measure: Overall survival
timeFrame: 24 Months
measure: Turnaround time for Guardant360 and tissue based genomic testing
timeFrame: 24 Months
measure: Molecular alteration discovery rates for various alterations
timeFrame: 24 Months
measure: Tumor response rates
timeFrame: 24 Months
measure: Quantity not sufficient rescue rates
timeFrame: 24 Months
measure: Tissue incomplete rescue rate
timeFrame: 24 Months
measure: The rate at which treatment plans are changed following results of the Guardant360 test
timeFrame: 24 Months
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross
state: Florida
Study officials:
References: