Recruiting

Molecular Residual Disease

Sponsor:

University Health Network, Toronto

Code:

NCT05196087

Conditions

Breast Cancer

Melanoma

Gastrointestinal Neuroendocrine Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05196087

Start date

Jul 20, 2022

Status verified date

Jun, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change from Baseline in ctDNA collected from biospecimens [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts and Locations

Central contacts

Celeste Yu, MSc

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

Elizabeth Shah

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

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Celeste Yu

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

Principal Investigator:

Lillian Siu, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 2, 2025

Last verified

Jun, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-07-02.