ClinicalTrials.gg
RecruitingNCT05196087NIP IT!Updated Sep 28, 2026

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

An observational study in Breast Cancer, Melanoma and Gastrointestinal Neuroendocrine Tumor, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by University Health Network, Toronto · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 3 months later.
Updated Sep 28, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 66 studies in Breast Neoplasms by University Health Network, Toronto — 18 open to participants now, 22 under way, 1 of them phase 3. Breast Neoplasms · University Health Network, Toronto.

Planned enrollment
5th of 25
800 · median 180
Started
2022
with 3 others
Observational
25 of 66
9 open now
Primary completion
2028-06
later than 16 of 21 live
Registered
53rd of 66
by date

Among the 66 studies in Breast Neoplasms by University Health Network, Toronto, this one is the 5th largest by planned enrollment of the 25 observational ones that give a count, is one of 4 that started in 2022, is one of 25 observational ones, reaches primary completion later than 16 of the 21 other live ones, and was the 53rd registered.

Breast Neoplasms

14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

18 of the 66 studies in Breast Neoplasms by University Health Network, Toronto are open now, in 10 countries. Recruiting first, the newest first:

12 more — sign in →

By country, each count listing its studies:

All 18 open studies →

Who these studies take

Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

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.

03

Conditions studied

  • Breast Cancer
  • Melanoma
  • Gastrointestinal Neuroendocrine Tumor

Keywords

  • Molecular Profiling
  • Minimal Residual Disease
  • Liquid Biopsy
  • Circulating Tumor DNA
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

None

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in ctDNA collected from biospecimens

    Next-generation sequencing based ctDNA analysis

    Time frame: 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

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

07

Study locations

1 of 1 sites recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    Recruiting
    • Celeste Yu · Contactceleste.yu@uhn.ca · 416-946-4501
    • Lillian Siu, MD · Principal investigator
    • Philippe Bedard, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified study data (including genetic data) may be potentially shared with approved research collaborators.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2022 (actual). Primary completion is estimated for Jun 2028, 71 months after the start.

Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's planned 71 months is above that.

Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 28, 2026: primary completion Jun 2027 → Jun 2028 and completion Jun 2027 → Jun 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2021
First posted
Jan 19, 2022
StartActual
Jul 20, 2022
Primary completionEst.
Jun 2028was Jun 2027
CompletionEst.
Jun 2028was Jun 2027
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 2027→Jun 2028
Sep 28, 2026
Study completion
Jun 2027→Jun 2028
Sep 28, 2026
Enrollment
500→800
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Primary completion Jun 2027→Jun 2028
    Study completion Jun 2027→Jun 2028
    Enrollment 500→800
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05196087
Collaborators
Princess Margaret Hospital, Canada
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
Jul 20, 2022
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Celeste Yu, MSc
Contact
celeste.yu@uhn.ca
416-946-4501 ext. 5281
Elizabeth Shah
Contact
elizabeth.shah@uhn.ca
416-946-4501 ext. 3833
Lillian Siu, MD
principal investigator · Princess Margaret Hospital, Canada
Philippe Bedard, MD
principal investigator · Princess Margaret Hospital, Canada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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