Galleri® in the Medicare Population.

Summary

This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek enrollment that is representative of the Medicare population.

Eligibility

Inclusion Criteria:

For Galleri + UC (Galleri-Tested Arm):

Participants are eligible to be included in the study only if all of the following criteria apply:

* Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
* Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).

For UC (Not Galleri-tested Arm):

Participants are eligible to be included in the study only if all of the following criteria apply:

* Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
* Have had ≥ 1 UC visit

Exclusion Criteria:

For Galleri + UC (Galleri-Tested Arm):

* Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
* Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):

  1. Diagnosed ≤3 years before expected enrollment date and/or
  2. Diagnosed \>3 years before expected enrollment date and never treated and/or
  3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
* Current pregnancy.
* Individuals who are currently inpatients at a participating site.
* Individuals who are not willing or able to comply with the protocol procedures.
* Individuals who are not currently registered patients at a participating center.
* Previous or current employees or contractors of GRAIL.

For UC (Not Galleri-tested Arm):

* Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
* Undergoing clinical evaluation for suspicion of cancer.
* Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):

  1. Diagnosed ≤3 years before expected enrollment date and/or
  2. Diagnosed \>3 years before expected enrollment date and never treated and/or
  3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
* Current pregnancy.
* Individuals who are currently inpatients at a participating site.

Conditions1

Locations47 sites

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