Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000695808
Ethics application status
Approved
Date submitted
15/03/2021
Date registered
7/06/2021
Date last updated
29/10/2021
Date data sharing statement initially provided
7/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with Ductal Carcinoma In Situ (DCIS) Following Breast Conserving Therapy to Determine the Clinical Utility of the DCISionRT Test in the Management of DCIS
Scientific title
A Prospective Registry Study to Evaluate the Clinical Utility of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy
Secondary ID [1] 303682 0
Nil
Universal Trial Number (UTN)
U1111-1266-0439
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ductal carcinoma in situ (DCIS) of the breast 321079 0
Condition category
Condition code
Cancer 318885 318885 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
After diagnosis of DCIS, sites will send the most representative tissue block (or sections mounted on charged slides) to PreludeDx for genetic testing using the DCISionRT test. 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 with completion of a follow-up form. Data captured pre and post-test will be captured in the registry along with follow up information and contribute to further hypothesis generation.

Participants will be provided with an patient information consent form as well as DCISionRT brochure and verbal information from their treating doctor.

The informed consent process and registry specific activities involving the participants will be carried out face-to-face by breast cancer surgeons and/or radiation oncologists depending on site processes.

The DCISionRT test will be ordered and carried out once only for each participant. This will be done at private or public breast cancer and radiation oncology clinics.

Routine Care Procedures (not part of the research):
1. Diagnosis of DCIS will be performed according to the standard of care at the participating institution and/or its referring clinical facilities.
2. The DCISionRT test will be ordered by completing the standard requisition form. The most representative tissue specimen will be selected by collaboration between the PreludeDx lab and local pathology lab as specified by work instructions for block selection and slide preparation as usual.
3. The PreludeDx lab will perform testing and reporting using the same protocols as for non-research samples, except for the addition of a study ID as defined below.

Study-Specific Procedures:
The sponsor and/or its agents will provide training to each participating center.

1. Investigators and/or study staff will pre-screen patients who have had DCISionRT testing ordered (or are in the process of being ordered) and select patients for possible enrollment. During pre-screening, existing patient medical records will be examined only to the extent necessary to determine whether the patient meets the eligibility criteria. No additional testing outside of routine clinical care is required to determine patient eligibility.

2. Informed consent will be carried out according to the local institutional policies. Once the informed consent has been provided by the patient, the patient is considered enrolled and there are no additional screening procedures or study-specific visits required.

3. Once the patient has provided informed consent, study staff will obtain a unique Study ID from the online registry and record this on the screening and enrollment log. Patients found to meet any exclusion criteria at any time will be excluded from the study.

4. A link between the Study ID and the patient’s identity must be maintained locally, preferably using the screening and enrollment log.

5. Study staff will either write the Study ID on the DCISionRT requisition form or notify the PreludeDx clinical lab that the patient is enrolled in the study so that the Study ID can be associated with the patient in the lab information system (LIS).

6. The Enrollment and Demographics (CRF1) and Pre-DCISionRT Treatment Recommendations Form (CRF2) will be completed with patient enrollment information and the treating physician or tumor board pre-test treatment recommendation, before the DCISionRT results are reported to the treating physician and study staff

7. In addition to routine reporting of DCISionRT results (either by fax or the PreludeDx online portal), DCISionRT results will be automatically transmitted to the de-identified online registry.

The treating physician or tumor board will complete the Post-test Treatment Recommendations Form (CRF3) as soon as possible after the DCISionRT results have been reported.
Intervention code [1] 319977 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326831 0
Percent of Cases with Changes in Treatment Recommendation


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.

Treatment recommendations will be determined based on source notes created by the investigators for this study.
Timepoint [1] 326831 0
Treatment recommendations are collected at enrolment (within 120 days of surgery) and once DCISionRT test results are available (approximately 1 week after sample is sent to to the testing laboratory).
Secondary outcome [1] 392833 0
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)

Demographic factors and changes in treatment recommendations will be determined based on source notes created by the investigators for this study.
Timepoint [1] 392833 0
Demographic factors and initial treatment recommendations will be captured at enrolment (within 120 days of surgery), Final treatment recommendations will be captured once test results are received (approximately 1 week after sample is sent to to the testing laboratory).
Secondary outcome [2] 394057 0
Function of Patient and Tumor Factors:
Percent of patients for which the recommended treatments change after DCISionRT results are known as a function of patient and tumor factors (Patient Age, tumor size, grade, architecture, necrosis, palpability, surgical margins, hormone receptor status, Histology, Multifocal, Family History, Genetic Testing Results, Patient Co-morbidities).

This outcome will be assessed by investigators documenting their three main reasons for the recommendation they have recorded.
Timepoint [2] 394057 0
Collected at enrolment (within 120 days of surgery) and once DCISionRT test results are available (approximately 1 week after sample is sent to to the testing laboratory).
Secondary outcome [3] 394058 0
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%).
Timepoint [3] 394058 0
At availability of the DCISionRT test results (approximately 1 week after sample is sent to to the testing laboratory).
Secondary outcome [4] 394059 0
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.

The geographic region is determined by the investigator's site address. Changes in treatment recommendations will be determined based on source notes created by the investigators for this study.
Timepoint [4] 394059 0
Treatment recommendations will be collected at enrolment (within 120 days of surgery) and once DCISionRT test results are available (approximately 1 week after sample is sent to to the testing laboratory)..

Eligibility
Key inclusion criteria
1. A clinical decision has been made to order the DCISionRT™ Test as part of routine patient care
2. 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)
3. Patient must be consented within 120 days after surgery
4. Patient must be eligible for, or have already received breast conserving surgery
5. Patient must be eligible to receive radiation and/or systemic treatment
6. Patient must be female and greater than 25 years old
7. Patient must be able to provide informed consent
Minimum age
26 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 invasive breast cancer or evidence in the ipsilateral or contralateral breast of invasive breast cancer, including microinvasion, lymph node involvement, or Paget’s disease of the nipple
3. Patient has already been surgically treated with a mastectomy for primary DCIS
4. Patient has prior in situ or invasive breast cancer
5. Patient is pregnant

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The PREDICT Registry is a non-interventional (non-randomized, observational), single-arm, multicenter study with the main objective of creating a de-identified database of patients, clinico-pathologic features, test results, treatment decisions and actual treatments with outcomes that can be queried to determine the clinical utility of the DCISionRT test in the diagnosis and treatment of DCIS. As such, the registry is designed to be hypothesis-generating, rather than focusing on a specific hypothesis that would define the sample size. Our main objective is to accumulate a large but affordable sample size (1,500) that could accommodate future hypotheses based on subsets of the general population of DCIS patients across the country.

Simple statistical analysis will be performed by calculating “rates of change” with appropriate confidence intervals for changes in pre-and post-testing treatment recommendations. Summary statistics will be used to present the treatment recommendation pre- and post- incorporation of Prelude DCISionRT test results and secondary analyses.

For instance, in order to assess the impact of DCISionRT results on recommendations for adjuvant RT, the percentage change in physician treatment recommendations will be calculated, and McNemar’s test for paired data will be used to assess the change in physician RT recommendations pre-test versus post-test. Recommendation change will be calculated as those patients who were initially recommended RT pre-test and then had a recommendation to omit RT post-test, and those patients initially recommended to omit RT pre-test and then had a recommendation to receive RT post-test. The percentage of patients who are initially recommended RT pre-test and are then recommended to omit RT post-test will also be calculated. Likewise, the percentage of patients who are initially recommended to omit radiation therapy pre-test and are then recommended to receive RT post-test will be calculated.

Multivariate logistic regression analyses will be used to assess the odds ratios (OR) of factors leading to the pre-test and the post-test RT recommendations. Pre-test covariates will include age, grade, tumor size, ethnicity, race, family history, necrosis, palpability, hormone receptor status, margin status, and patient preference as well as clinician specialty. Post-test covariates will also include the DCISionRT test results. Statistical analyses will be performed using R (https://www.r-project.org) or SAS.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2021
Actual
1/07/2021
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
1/05/2034
Actual
Sample size
Target
1500
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 18892 0
GenesisCare – Wembley - Wembley
Recruitment hospital [2] 18893 0
Genesis Cancer Care - Southport - Southport
Recruitment hospital [3] 18894 0
Genesis Cancer Care - Tugun - Tugun
Recruitment hospital [4] 18895 0
Genesis Cancer Care - Wesley - Auchenflower
Recruitment hospital [5] 18896 0
Genesis Cancer Care - Chermside - Chermside
Recruitment hospital [6] 18897 0
Genesis Cancer Care - Gateshead
Recruitment hospital [7] 18898 0
Genesis Cancer Care - Nambour - Nambour
Recruitment hospital [8] 18899 0
GenesisCare – Shenton House - Joondalup
Recruitment hospital [9] 18900 0
GenesisCare St Leonards - St Leonards
Recruitment postcode(s) [1] 33399 0
6014 - Wembley
Recruitment postcode(s) [2] 33400 0
4215 - Southport
Recruitment postcode(s) [3] 33401 0
4224 - Tugun
Recruitment postcode(s) [4] 33402 0
4066 - Auchenflower
Recruitment postcode(s) [5] 33403 0
4032 - Chermside
Recruitment postcode(s) [6] 33404 0
2290 - Gateshead
Recruitment postcode(s) [7] 33405 0
4560 - Nambour
Recruitment postcode(s) [8] 33406 0
6027 - Joondalup
Recruitment postcode(s) [9] 33407 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 308100 0
Commercial sector/Industry
Name [1] 308100 0
PreludeDx
Country [1] 308100 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Prelude Australia Pty Limited
Address
Level 13, 41 Exhibition Street, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 308853 0
None
Name [1] 308853 0
None
Address [1] 308853 0
Country [1] 308853 0
Other collaborator category [1] 281687 0
Commercial sector/Industry
Name [1] 281687 0
GenesisCare Clinical CRO
Address [1] 281687 0
Building 1&11, The Mill, 41-43 Bourke Rd, Alexandria NSW 2015
Country [1] 281687 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308086 0
North Shore Local Health District Human Research Ethics Committee
Ethics committee address [1] 308086 0
Ethics committee country [1] 308086 0
Australia
Date submitted for ethics approval [1] 308086 0
31/03/2021
Approval date [1] 308086 0
29/04/2021
Ethics approval number [1] 308086 0
2021/ETH00597

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109482 0
Dr Yvonne Zissiadis
Address 109482 0
GenesisCare, 24 Salvado Rd, Wembley WA 6014
Country 109482 0
Australia
Phone 109482 0
+61 8 9381 5655
Fax 109482 0
Email 109482 0
[email protected]
Contact person for public queries
Name 109483 0
Tracy Pearce
Address 109483 0
GenesisCare, 126 Wellington Parade, East Melbourne VIC
Country 109483 0
Australia
Phone 109483 0
+61 3 94276500
Fax 109483 0
Email 109483 0
[email protected]
Contact person for scientific queries
Name 109484 0
Tracy Pearce
Address 109484 0
GenesisCare, 126 Wellington Parade, East Melbourne VIC
Country 109484 0
Australia
Phone 109484 0
+61 3 94276500
Fax 109484 0
Email 109484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study documents and data generated are confidential. Results will be published in relevant journals and/or conferences.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe PREDICT registry Australia: A prospective registry study to evaluate the clinical utility of the DCISionRT test on treatment decisions in patients with DCIS following breast conserving surgery.2022https://dx.doi.org/10.1158/1538-7445.SABCS21-OT1-11-01
EmbaseThe PREDICT Registry Australia: A prospective registry to evaluate the clinical utility of a 7-gene predictive biosignature on treatment decisions in patients with ductal carcinoma in situ.2023https://dx.doi.org/10.1158/1538-7445.SABCS22-OT3-11-03
N.B. These documents automatically identified may not have been verified by the study sponsor.