AUTO-CHECK: Molecular determinants of autoimmunity and immune related adverse events in advanced cancer participants treated with immune checkpoint inhibitors

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621001596897

Acronym

AUTO-CHECK

Enrollment

261

Registered

2021-11-22

Start date

2017-06-07

Completion date

2019-12-18

Last updated

2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Checkpoint inhibitors are a new and effective class of cancer treatment. Sometimes these drugs result in unpredictable and severe inflammatory side effects. We will apply techniques that have helped us understand autoimmune disease to investigate patients treated with checkpoint inhibitors, aiming to elucidate how individual genetic variation predisposes patients to side effects. If successful, this project will improve how these powerful drugs are prescribed and reduce the risk of toxicity.

Interventions

This is an observational translational research substudy that will collect biospecimens and data from cancer patients participating in any of 6 investigator-initiated multi-centre clinical trials of immunotherapy (DREAM, PHAEDRA, NIVORAD, NUTMEG, KEYPAD and ILLUMINATE) and one single-site observational cohort (patients receiving any immunotherapy for any type of advanced cancer). The general aim of this study is to determine the genetic and cellular basis for susceptibility to autoimmune adverse effects in patients receiving immune checkpoint inhibitors (ICIs). Participation involves providing a blood sample at up to 3 timepoints: at baseline before commencing ICIs, 4-12 weeks after commencing ICIs, and at the time of any IRAE should it occur. The observational period is from the first dose of ICI, for a minimum of 12 months per patient, and involves access to medical records only.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Any participant who receives at least one dose of ICI treatment in any of the following studies: DREAM, PHAEDRA, NIVORAD, NUTMEG, KEYPAD, ILLUMINATE and OCPI. 2. Written, informed consent for translational research.

Exclusion criteria

None

Outcome results