Does Screening With the Galleri Test in the NHS Reduce the Likelihood of a Late-stage Cancer Diagnosis in an Asymptomatic Population? A Randomised Clinical Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Multi-cancer early detection test (Galleri test): Blood collection and multi cancer early detection testing with return of positive test results.

Study summary

The Galleri test is a new test that looks for potential signs of cancer in a blood sample. The test can find many different types of cancer but cannot find all cancers. The trial aims to see if using the Galleri test alongside standard cancer testing in the NHS can help to find cancers at an early stage when they are easier to treat.

The trial has enrolled approximately 140,000 participants who will be actively followed for approximately three years from the date of enrollment.

Eligibility

Primary outcome measure(s)

• incidence of stage III and IV cancers diagnosed in the intervention arm as compared with the control arm — 3-4 years after randomization
  using a fixed-sequence statistical strategy as below: * first, evaluate for a statistically significant difference in a prespecified group of primary cancer types: lung, head \& neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, oesophagus, anus, lymphoma, ovary, and bladder. * if a statistically significant reduction in absolute numbers is found, continue by evaluating for a difference in all cancer types excluding prostate cancer. * If the above evaluations are both significant, evaluate for a difference in all cancer types.

Trial sites (1)

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