An observational study in Breast Cancer, Stage 0, sponsored by University of Washington. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Washington · Observational
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Among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States — 31 open to participants now, 51 under way, 6 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · United States.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, this one is the 18th largest by enrollment of the 38 observational ones that give a count, is one of 10 that started in 2018, is one of 38 observational ones, reaches primary completion later than 6 of the 50 other live ones, and was the 154th registered.
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
Browse Carcinoma, Intraductal, Noninfiltrating studies →31 of the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States are open now. Recruiting first, the newest first:
Providence Health & Services · Sites in United States
Ages 18+
HeroSupport SA · Sites in United States
Ages 40+ · Women only
University of Florida · Sites in United States
Ages 18+
Barbara Ann Karmanos Cancer Institute · Sites in United States
Ages 18+ · Women only
National Cancer Institute (NCI) · Sites in United States
Ages 45–74 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years to 80 Years · female.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
210 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 68 · Phase 3 15 · Phase 4 1
First in 1991; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 122 is below the median of 201 across 59 observational studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Median enrollment 51 across the 171 interventional studies, 109 across the 38 observational. Of the 140 that completed or were terminated, 59 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 210 have an industry lead sponsor. The 10 most frequent:
University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
University of Washington has 3 studies filed under Carcinoma, Intraductal, Noninfiltrating — fewer than ten, so there is no comparison to draw.
15 of the studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04722692Phase 3Uppsala UniversityDelayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ | 2026-12-30 |
| NCT03546972M.D. Anderson Cancer CenterDiabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants | 2026-11-30 |
| NCT03909282Stanford UniversitySurgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma | 2026-12 |
| NCT03448926PreludeDxThe PREDICT Registry: | 2026-12 |
| NCT05340673City of Hope Medical CenterComparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer | 2026-12-15 |
Add all 15 to your calendar (.ics) → With an account.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).
The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.
The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.
The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).
286 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 55 are open to participants now.
This study's enrollment of 122 is below the median of 201 across 59 observational studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Carcinoma In Situ. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).
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.
Exclusion Criteria for Both Cohorts:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing.
Diagnostic Test: Breast MRI · Other: Laboratory Biomarker Analysis
Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing.
Diagnostic Test: Breast MRI · Other: Laboratory Biomarker Analysis
Quantitative, multiparametric breast MRI
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Also known as: Oncotype Dx
Fractional perfusion (f)
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Time frame: 3.5 years
Tissue diffusion (Dt)
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Time frame: 3.5 years
Transfer constant (Ktrans)
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
Time frame: 3.5 years
Signal enhancement ratio (SER)
Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Time frame: 3.5 years
Apparent diffusion coefficient (ADC)
Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Time frame: 3.5 years
Oncotype DCIS Score
Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score\<39)
Time frame: 3.5 years
Transfer constant (Ktrans)
Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
Time frame: 3.5 years
Fractional perfusion (f)
Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
Time frame: 3.5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2018 to primary completion in Apr 2023, 60 months.
Of 28 non-industry observational studies under Carcinoma, Intraductal, Noninfiltrating, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 86. This study's 60 months is close to that.
Counting every sponsor, half of 30 studies reached it within 60 months; a quarter within 46 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Intraductal, Noninfiltrating →