Observational Study for Ductal Breast Carcinoma In Situ
The PREDICT Registry:
Recruiting
Observational Study
DCISStage 0 Breast CancerDuctal Breast Carcinoma In Situ
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 85
Sex
Female
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
PreludeDx · Industry
Who this trial is looking for
This trial is looking for women with ductal carcinoma in situ (DCIS) in one breast. Participants will be asked to give consent and may undergo a specific test as part of their routine care.
Are You a Good Fit for This Trial?
You may be able to join if
I have ductal carcinoma in situ (DCIS) in one breast.
I am between 30 and 85 years old.
I have a tumor size of less than 6 cm.
I was diagnosed with DCIS within the last 120 days.
I can have breast-conserving surgery.
I can receive radiation or systemic treatment.
I have the DCISionRT test ordered during my care.
You may not be able to join if
I have invasive breast cancer or suspicious findings.
I have had a mastectomy for DCIS.
I have had any prior DCIS or invasive breast cancer.
I have had prior radiation in the same breast.
I have had systemic endocrine or chemotherapy before testing.
I am pregnant.
I do not have enough tissue for the test.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each pa…
This is a prospective, non-interventional (observational) cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria (see below) will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB), WCG IRB, will approve the protocol and each participating institution.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion criteria
1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
2. Patient must have the DCISionRT test ordered during routine patient…
Inclusion criteria
1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable).
2. Patient must have the DCISionRT test ordered during routine patient care.
3. Patient must be eligible for or have recently completed breast conserving surgery.
4. Patient must be eligible to receive radiation and/or systemic treatment.
5. Patient must be 30 to 85 years old.
6. Patient must have tumor size of less than 6 cm.
7. Patient must have been diagnosed with DCIS within 120 days of consent.
Exclusion criteria
1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing.
2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget's disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast.
3. Patient has been surgically treated with an ipsilateral mastectomy for primary DCIS.
4. Patient has had any prior ipsilateral or contralateral breast DCIS or invasive breast cancer.
5. Patient has a prior history of in-field radiation in the ipsilateral breast.
6. Patient has had prior systemic endocrine or chemotherapy prior to testing.
7. Patient is pregnant.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.