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

NCT05196087 | Recruiting

• 1 other identifier: NIP IT!
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Melanoma; Gastrointestinal Neuroendocrine Tumor

Keywords

Molecular Profiling; Minimal Residual Disease; Liquid Biopsy; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in ctDNA collected from biospecimens

  Next-generation sequencing based ctDNA analysis

  Through study completion, an average of 4 years

Secondary Outcomes (1)

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

  Through study completion, an average of 4 years

Study Arms (1)

NIP IT!

Patients with early stage or locally advanced disease that is planned for or have undergone curative treatment will have next-generation sequencing (NGS)-based ctDNA analysis performed on blood samples to determine minimal residual disease (MRD). Blood samples, stool samples, and additional archival/fresh tumor specimens will be collected for banking and future research purposes.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Early stage or locally advanced disease that is planned for or have undergone curative treatment.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival/fresh tumor tissue, blood samples, stool samples

MeSH Terms

Conditions

Breast Neoplasms; Melanoma; Gastro-enteropancreatic neuroendocrine tumor; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lillian Siu, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Philippe Bedard, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celeste Yu, MSc

CONTACT

416-946-4501; celeste.yu@uhn.ca

Elizabeth Shah

CONTACT

416-946-4501; elizabeth.shah@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 19, 2022
• Study Start: July 20, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CA (1)