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Recruiting

NCT Number: NCT05196087

Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)

Patients who have undergone curative treatment may be at risk of relapse. This study will collect, annotate, and sequence biospecimens (blood, stool, and tissue) from patients across different tumor types to detect molecular residual disease (MRD) before metastases become radiographically or clinically detectable. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Celeste Yu

CONTACT

[email protected]

416-946-4501 ext. 5281

Lillian Siu, MD

PRINCIPAL_INVESTIGATOR

Philippe Bedard, MD

PRINCIPAL_INVESTIGATOR

About this study

The development of anticancer drugs typically starts with patients with advanced cancers who have exhausted standard treatments. Yet even the most active new drugs produce only modest benefits in patients with advanced cancers because of the emergence of resistance, similar to the resistance that bacteria develop when they are repeatedly exposed to antibiotics. In order to achieve larger magnitude gains in survival and make greater impact in the field of cancer, promising drugs must be tested in patients with curable malignancies who have undergone definitive treatment but are at high risk of relapse. Interception is the active intervention of cancers at an early stage, offering an opportunity to eliminate molecular residual disease (MRD) before clinical relapse. MRD describes the situation in which cancer-derived biomarkers are detectable, typically using highly sensitive and specific molecular assays in blood or other body substances that are below the threshold of detection by conventional tests such as CT scans or radiological imaging. Using innovative technologies to monitor patients at high risk of relapse, and applying them to serial samples of their circulating tumor DNA, other body fluids, stool and radiological images, the goal is to develop AI-based models to identify those who are at the highest risk of relapse. This will allow interception studies to be conducted to target microscopic tumor cells in these patients to increase cancer cure rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histological confirmation of a solid tumor.
  • Patients must have early stage or locally advanced disease that is planned for or have undergone curative treatment.
  • Patient must be ≥ 18 years old.
  • All patients must have signed and dated an informed consent form.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Change from Baseline in ctDNA collected from biospecimens

    Time frame: Through study completion, an average of 4 years

    Next-generation sequencing based ctDNA analysis

Secondary outcomes

  1. Number of participants that are identified as high risk of clinical relapse with artificial intelligence (AI) and machine learning algorithms

    Time frame: Through study completion, an average of 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Celeste Yu, MSc

CONTACT

[email protected]

416-946-4501 ext. 5281

Elizabeth Shah

CONTACT

[email protected]

416-946-4501 ext. 3833

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Acronym: NIP IT!

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 19, 2022
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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