The PREDICT Registry for DCIS Patients With DCISionRT Testing

DCIS Clinical Trial

— PREDICT  

Official title:

A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients With DCIS Following Breast Conserving Therapy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03448926
• Other study ID #: 20172841
• Status: Suspended
• Start date: February 27, 2018
• Est. completion date: November 2035

Study information

• Verified date: October 2022
• Source: PreludeDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective cohort study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast.

Description:

This is a prospective cohort study conducted within the medical network of the participating investigators and institutions. Patients meeting the eligibility criteria outlined above will be eligible for participation and the investigators will obtain written informed consent. A central Institutional Review Board (IRB) will approve the protocol and each participating institution.

After diagnosis of DCIS, the most representative tissue block (or 10 sections mounted on charged slides cut at 3 microns) will be sent to PreludeDx for DCISionRT. The most representative specimen should be selected from tissue collected via direct tumor biopsy (either FNA, core needle or excisional biopsy) as part of routine patient care. Patients must be enrolled in the study and the enrollment and pre-testing data forms must be completed and submitted before the DCISionRT results are reported. Then, after review of the DCISionRT results, the investigators complete and submit the post-testing data form. The patient may then be followed for up to 10 years (or until death) with completion of a yearly follow-up form.

All study data will be stored in an encrypted, HIPAA-compliant database maintained by the coordinating center. Each consented patient will be assigned a unique Study ID number. Study personnel at each institution will maintain an electronic key to link the Study IDs of its own patients to the patients' local medical record number. All personal health information (PHI) will remain at the local institution and only de-identified data will be uploaded to the national registry. No genetic test results that may be used to identify the patient will be included in the database.

This study anticipates the participation of 25 to 100 sites within the United States with each site enrolling between 10 and 100 patients. The study is designed to collect information for up to 2,500 patients.

The purpose of this study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the clinical utility of the DCISionRT™ Test in the management of DCIS, as it is broadly incorporated into clinical practice. The primary objective is to identify a statistically significant difference in physician treatment recommendations for patients diagnosed with DCIS and treated with breast conserving surgery based on availability of the DCISionRT test results. The primary endpoints are treatment recommendations according to standard procedure at each clinical site both pre- and post-DCISionRT results.

Secondary endpoints include the percent of patients for which the recommended treatment before DCISionRT results and after DCISionRT results differ as a function of clinical factors, such as age groups (<40, 40-50 and >50), grade (I, II, III), and tumor size (>1cm, >2.5cm, >4cm). Other analyses involve the identification of key driver(s) of treatment recommendation, such as age, ethnicity, race, family history, presentation (screening/clinical), grade, architecture, necrosis, tumor size, palpability, number of excisions, surgical margin, hormone receptor status, HER2 status; distribution of DCISionRT scores across the cohort; and identification of key driver(s) of treatment recommendation based on geographic region of the investigator.

The study population will be selected from the clinical practices of the participating investigators and institutions. Patients who have been recently diagnosed with DCIS and are being evaluated for the need for further therapy will be screened for eligibility per the following eligibility criteria.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2500
• Est. completion date: November 2035
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion criteria

• 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)

• Patient must have the DCISionRT™ Test ordered during routine patient care

• Patient must be planning to undergo breast conserving surgery

• Patient must be eligible to receive radiation and/or systemic treatment

• Patient must be greater than 25 years old

• Patient must have been diagnosed with DCIS within 120 days of consent

• Patient must be able to provide informed consent

Exclusion criteria

• Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing

• 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

• Patient has been surgically treated with a mastectomy for primary DCIS

• Patient has prior in situ or invasive breast cancer

• Patient is pregnant

• Patient was previously enrolled onto this registry

Related Conditions & MeSH terms

• DCIS

Intervention

Other:
• Treatment Recommendation Surveys
Treatment Recommendation Surveys are completed by the treating physicians before and after receiving results from the DCISionRT test, which is prognostic for risk of recurrence over 10 years and predictive for benefit from radiation therapy.

Locations

Country	Name	City	State
Australia	GenesisCare	Alexandria	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
United States	Cleveland Clinic Akron General	Akron	Ohio
United States	Summa Health	Akron	Ohio
United States	AdventHealth Hematology & Oncology	Altamonte Springs	Florida
United States	University of Colorado Denver	Aurora	Colorado
United States	MedStar Health Research Institute	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	St Luke's University Health Network Bethlehem	Bethlehem	Pennsylvania
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Maimonides Cancer Center	Brooklyn	New York
United States	MD Anderson Cancer Center at Cooper	Camden	New Jersey
United States	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa
United States	UnityPoint Health	Cedar Rapids	Iowa
United States	Erlanger Radiation Oncology - Baroness Campus	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation Taussig Cancer Institute	Cleveland	Ohio
United States	UC Health - Memorial Hospital, Colorado Springs	Colorado Springs	Colorado
United States	The Ohio State University	Columbus	Ohio
United States	Dallas Surgical Group	Dallas	Texas
United States	Shaw Cancer Center	Edwards	Colorado
United States	Alexian Brothers Medical Center (AMITA Health)	Elk Grove Village	Illinois
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Regional Breast Care	Fort Myers	Florida
United States	Fresno Cancer Center	Fresno	California
United States	The West Clinic	Germantown	Tennessee
United States	Bon Secours St Francis Cancer Center	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Elizabeth Bonefas, MD	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Southwest Surgical Associates	Houston	Texas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Knoxville Comprehensive Breast Center	Knoxville	Tennessee
United States	Northwell Health	Lake Success	New York
United States	Good Samaritan Hospital	Los Gatos	California
United States	WellStar Health System	Marietta	Georgia
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	Bon Secours Virginia Breast Center	Midlothian	Virginia
United States	Memorial Medical Center Sutter Health	Modesto	California
United States	Atlantic Health Care Morristown Medical Center	Morristown	New Jersey
United States	Naples Community Hospital Center for Breast Health	Naples	Florida
United States	Southwest Florida Breast Surgery	Naples	Florida
United States	Nashville Breast Center	Nashville	Tennessee
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Advocate Health Care	Park Ridge	Illinois
United States	Arizona Center for Cancer Care	Phoenix	Arizona
United States	UPMC Hillman Cancer Center Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Adventist Healthcare	Rockville	Maryland
United States	Beaumont Health Royal Oak	Royal Oak	Michigan
United States	Pam Benitez MD	Royal Oak	Michigan
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Mills-Peninsula Medical Center	San Mateo	California
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Ironwood Cancer and Research Centers	Scottsdale	Arizona
United States	Grand View Health	Sellersville	Pennsylvania
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Dana-Farber/Brigham and Women's Cancer Center at South Shore	South Weymouth	Massachusetts
United States	Summit Cancer Centers	Spokane Valley	Washington
United States	St. Joseph's Hospital Tampa	Tampa	Florida
United States	USF Breast Health Program	Tampa	Florida
United States	Comprehensive Breast Care	Troy	Michigan
United States	Aspirus Regional Cancer Center	Wausau	Wisconsin
United States	21st Century Oncology	Wellington	Florida
United States	Northwestern Medicine Central DuPage Hospital	Winfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
PreludeDx	University of South Florida

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Bremer et al. Cancer Research. Feb 2017. Vol 77 Issue 4 Supp. SABCS16-S5-0.1

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Distribution of DCISionRT scores across the cohort	Each patient will receive the following results from the DCISionRT test: Risk Score (0 - 10.0), Risk Category Low (<=3.0) or Elevated (>3.0), Risk Prognosis with Breast Conserving Therapy Alone (0 - 40%) and Risk Prognosis with Breast Conserving Therapy and Radiation (0 - 40%).	5 years
Other	Function of Geographic Region	Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of the geographic region of the investigator.	5 years
Primary	Percent of Cases with Changes in Treatment Recommendation	The study will collect details on physician treatment recommendations before and after availability of the genomic test (DCISionRT) results. The data elements include type of surgery (lumpectomy, therapeutic mastectomy, contralateral prophylactic mastectomy), type of radiation therapy (none, IORT, APBI, whole breast RT) and endocrine therapy (yes, no). The main measure will be percent of cases in which treatment recommendations are changed after the test results become available.	5 years
Secondary	Function of Demographic Factors	Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of demographic factors (age groups <40, 40-50 and >50; ethnicity; family history)	5 years
Secondary	Function of Tumor Factors	Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of tumor factors (tumor size, grade, architecture, necrosis, palpability, surgical margins, hormone receptor status).	5 years