Clinical trial NCT05196087: Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)
Official title: Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Melanoma
Gastrointestinal Neuroendocrine Tumor
Keywords: Molecular Profiling
Minimal Residual Disease
Liquid Biopsy
Circulating Tumor DNA
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2022-01-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early stage or locally advanced disease that is planned for or have undergone curative treatment.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

Primary outcomes:
measure: Change from Baseline in ctDNA collected from biospecimens
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Number of participants that are identified as high risk of clinical relapse with artificial intelligence (AI) and machine learning algorithms
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Lillian Siu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Philippe Bedard, MD
role: PRINCIPAL_INVESTIGATOR
References: