CompletedNot Applicable

Selection Pressure and Evolution Induced by Immune Checkpoint Inhibitors and Other Immunologic Therapies

14 participantsStarted 2015-04

Plain-language summary

Two part prospective study to: 1. investigate the feasibility of performing ultra-deep sequencing of plasma derived circulating tumor DNA (ctDNA) in individual patients with advanced solid tumors who are currently being treated with immune checkpoint inhibitors (ICIs) and 2. obtain fresh tumor biopsies and serial blood samples to investigate the clonal evolution of tumors under the selection pressure of ICIs.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age \> 18 years.
. Histological or cytological proof of metastatic solid tumors.
. Currently receiving immune checkpoint inhibitors or other immunologic therapies of interest (to be determined by study principal investigators).
. Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion criteria

. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
. Any contraindication to undergoing a venepuncture.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: The detection of new mutations from circulating tumor DNA (ctDNA) analyses or change in the frequency of mutations found in archival tumor Whole Exome Sequencing (WES) analyses.

Timeframe: 5 years

Part 2: Concordance between WES analyses of serial tumor biopsies.

Timeframe: 5 years

Trial details

NCT IDNCT02724488

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01

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