The PREDICT Registry for DCIS Patients With DCISionRT Testing (PREDICT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03448926 |
|
Recruitment Status :
Suspended
(Part 1 of the study reached the original enrollment goal. The protocol is being amended to begin enrollment for Part 2 soon.)
First Posted : February 28, 2018
Last Update Posted : March 13, 2023
|
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | February 16, 2018 | |||||||||
| First Posted Date | February 28, 2018 | |||||||||
| Last Update Posted Date | March 13, 2023 | |||||||||
| Actual Study Start Date | February 27, 2018 | |||||||||
| Estimated Primary Completion Date | November 2025 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Percent of Cases with Changes in Treatment Recommendation [ Time Frame: 5 years ] 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.
|
|||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
|
|||||||||
| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | The PREDICT Registry for DCIS Patients With DCISionRT Testing | |||||||||
| 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 | |||||||||
| Brief 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. | |||||||||
| Detailed 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. |
|||||||||
| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | 10 Years | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | 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. | |||||||||
| Condition | 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.
|
|||||||||
| Study Groups/Cohorts | DCIS
Patients must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast without evidence of invasive cancer (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)
Intervention: Other: Treatment Recommendation Surveys
|
|||||||||
| Publications * | Bremer et al. Cancer Research. Feb 2017. Vol 77 Issue 4 Supp. SABCS16-S5-0.1 | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Suspended | |||||||||
| Estimated Enrollment |
2500 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | November 2035 | |||||||||
| Estimated Primary Completion Date | November 2025 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion criteria
Exclusion criteria
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 25 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Australia, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03448926 | |||||||||
| Other Study ID Numbers | 20172841 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement |
|
|||||||||
| Current Responsible Party | PreludeDx | |||||||||
| Original Responsible Party | Charles Cox, University of South Florida, McCann Foundation Endowed Professor of Breast Surgery | |||||||||
| Current Study Sponsor | PreludeDx | |||||||||
| Original Study Sponsor | University of South Florida | |||||||||
| Collaborators | University of South Florida | |||||||||
| Investigators |
|
|||||||||
| PRS Account | PreludeDx | |||||||||
| Verification Date | October 2022 | |||||||||