A Study to Establish a Registry of Guardant360® Use and Outcomes In People With Advanced Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-007040
NCT ID: NCT03477474
Sponsor Protocol Number: 01-MX-003
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
General Inclusion Criteria:
- 18 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.
General Exclusion Criteria:
- 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).
Inclusion Criteria:
- 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:
- Noprior systemic therapy for advanced disease; OR
- All three of the following conditions:
- A history of prior systemic therapy for advanced disease;
- Disease progression within the previous four weeks; and
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Yanyan Lou, M.D., Ph.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available