Breast CancerNIP IT!NCT05196087
Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)
An observational study of Breast Cancer and Melanoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Melanoma, Gastrointestinal Neuroendocrine Tumor
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2022to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early stage or locally advanced disease that is planned for or have undergone curative treatment.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Celeste Yu, 416-946-4501 ext. 5281, celeste.yu@uhn.ca
Lillian Siu, MD
About this study
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.
Read the 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.
- Keywords
- Molecular Profiling, Minimal Residual Disease, Liquid Biopsy, Circulating Tumor DNA
- Medical subject headings
- Breast Neoplasms, Melanoma, Gastro-enteropancreatic neuroendocrine tumor, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ctDNA collected from biospecimens
Next-generation sequencing based ctDNA analysis
Measured: 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
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start20 Jul 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, MD, Principal investigator, Princess Margaret Hospital, CanadaPhilippe Bedard, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196087
- Sponsor's protocol ID
- NIP IT!
- Acronym
- NIP IT!
- Status last verified
- Sep 2026
- First submitted
- 13 Dec 2021
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified study data (including genetic data) may be potentially shared with approved research collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Artificial Intelligence-Based Platform MonIToring Program (NIP IT!)
- ClinicalTrials.gov ID
- NCT05196087
- Acronym / sponsor ID
- NIP IT! / NIP IT!
- Keywords
- Molecular Profiling, Minimal Residual Disease, Liquid Biopsy, Circulating Tumor DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early stage or locally advanced disease that is planned for or have undergone curative treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in ctDNA collected from biospecimens
Time frame: Through study completion, an average of 4 years
Next-generation sequencing based ctDNA analysis
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. De-identified study data (including genetic data) may be potentially shared with approved research collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lillian Siu, MD principal investigator
Princess Margaret Hospital, Canada
Philippe Bedard, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Melanoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celeste Yu, MSc (416-946-4501 ext. 5281, celeste.yu@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in ctDNA collected from biospecimens (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.