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Trial details
Vanessa
Current status:
Approved
|
Date registered:
16/05/2023
Trial version(s)
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
History: 05/12/2021
Current: 05/12/2021
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Main Information
Primary registry identifying number
LBCTR2021124932
Protocol number
MO42921
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Not Applicable
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
F. HOFFMANN-LA ROCHE LTD
Primary sponsor: Country of origin
Switzerland
Public title
Vanessa
Acronym
Vanessa
Scientific title
A MULTI-COUNTRY OBSERVATIONAL RETROSPECTIVE STUDY TO EVALUATE THE PREVALENCE OF PD-L1 AND ITS ROLE IN PATIENTS WITH TNBC TREATED WITH SYSTEMIC THERAPY
Acronym
Vanessa
Brief summary of the study: English
This is an observational, multi-country study with secondary data use (NIS SDU); medical/treatment history data will be retrospectively extracted from medical records and archived tissue samples will be analyzed. Approximately 2,700 patients with a new diagnosis of eTNBC or mTNBC between 1st January 2014 and 31st December 2017 will be considered for inclusion in this study. Treatment choice (systemic therapy) has been made at the discretion of the treating physician/multidisciplinary team as per local guidelines and before the patients' enrollment in this non-interventional study. Thus, the treatment choice was independent of participation in this retrospective study. No study/specific visits are mandated by the study, no additional tests will be performed on patients due to their participation in this study, and no additional tissue samples will be obtained.
Brief summary of the study: Arabic
هذه دراسة رصدية متعددة البلدان باستخدام البيانات الثانوية (NIS SDU) ؛سيتم استخراج بيانات التاريخ الطبي / العلاج بأثر رجعي من السجلات الطبية و سيتم تحليل عينات الأنسجة المؤرشفة. ما يقرب من 2700 مريض جديد بتشخيص eTNBC أو mTNBC بين 1 يناير 2014 و 31 ديسمبر 2017 يتم النظر في إدراجها في هذه الدراسة. تم اختيار العلاج (العلاج الجهازي) وفقًا لتقدير الطبيب المعالج / الفريق متعدد التخصصات وفقًا للإرشادات المحلية وقبل تسجيل المرضى في هذه الدراسة غير التدخلية. وبالتالي ، كان اختيار العلاج مستقلاً عن المشاركة في هذه الدراسة بأثر رجعي. لا تُفرض الدراسة / زيارات محددة من قبل الدراسة ، ولن يتم إجراء اختبارات إضافية على المرضى بسبب مشاركتهم في هذه الدراسة ، ولن يتم الحصول على عينات أنسجة إضافية.
Health conditions/problem studied: Specify
The study population is intended to follow the real-world use of systemic therapy. Eligible patients with either eTNBC or mTNBC will be enrolled consecutively; it is anticipated that sufficient numbers of eTNBC and mTNBC will be achieved with sequential enrollment in as many sites as needed and no stratification will be performed.
Interventions: Specify
Non-interventional study
Key inclusion and exclusion criteria: Inclusion criteria
Patient cases must meet the following criteria for study entry: 1. Signed Informed Consent Form, if and as required, according to local laws and regulations 2. Aged ≥ 18 years at the time of diagnosis 3. Histologically documented TNBC, assessed locally and defined as ER and PR positivity of less than 1% and HER2 IHC0, IHC1+, or IHC2+/ISH-, as determined according to ASCO/CAP guidelines (Allison et al. 2020; Wolff et al. 2018; Wolff et al. 2013) 4- New diagnosis of eTNBC (early or locoregionally advanced TNBC, amenable to treatment with curative intent) or mTNBC (metastatic or locoregionally advanced unresectable TNBC, not amenable to treatment with curative intent) between 1st January 2014 and 31st December 2017 5- Available formalin-fixed paraffin-embedded (FFPE) tumor tissue of good quality based on total and viable tumor content for local and central laboratory PD-L1 testing (see 8.1.1 for detailed requirements) 6- Documentation of tissue source (primary breast cancer, de novo breast cancer, metastatic tumor location), biopsy or resection, tissue size, and tumor content 7- Patients that received any systemic therapy in early-stage disease and/or in metastatic setting Only patients with documented, locally determined PD-L1 status using Ventana PD-L1 (SP142) assay by trained pathologists, will be eligible for central testing and their data will be included in the study analysis.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
Patients who meet any of the following criteria will be excluded from study entry: 1- No available archival tumor tissue for PD-L1 testing 2- Tissue samples of poor quality based on total and viable tumor content and/or bad fixation 3- Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable 4- Patients whose tumor tissue is not evaluable for local and central testing
Type of Study
Type
Observational
Study model
Cohort
Study model: Explain model
This study will evaluate the prevalence of PD-L1 positivity rates in tumors from patients with TNBC. The study population will comprise two cohorts: Cohort 1 will include patients with eTNBC Cohort 2 will include patients with mTNBC
Time perspective
Retrospective
Time perspective: Explain time perspective
This is an observational, multi-country study with secondary data use (NIS SDU); medical/treatment history data will be retrospectively extracted from medical records and archived tissue samples will be analyzed. Approximately 2,700 patients with a new diagnosis of eTNBC or mTNBC between 1st January 2014 and 31st December 2017
Target follow-up duration
1
Target follow-up duration: Unit
year
Number of groups/cohorts
2
Biospecimen retention
Samples with DNA**
Biospecimen description
The main study will only use archival tissue (FFPE samples) samples to test the presence of PD-L1. This is an IHC assay and does not involve any genetic testing. However the Optional Samples for the RBR will be collected from patients who give specific consent to participate in this optional research. RBR samples will be stored, analyzed and used for research purposes, including, but not limited to, research on biomarkers related to cancer treatment or diseases: Additional archival tumor tissue samples (e.g., primary tumor, recurrence, or metastasis) in form of a tissue punch for the generation of a tissue microarray (TMA). & Leftover unstained tissue slides and any derivatives thereof (e.g., DNA, RNA, proteins, peptides). Those samples may be sent to one or more laboratories for analysis of germline or somatic variants via whole genome sequencing (WGS), whole exome sequencing (WES), or other genomic analysis methods.
Target sample size
40
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/02/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2022
Recruitment status
Pending
Date of completion
31/12/2022
IPD sharing statement plan
Yes
IPD sharing statement description
During this study, health and personal information about subjects and archived tissue samples will be collected. This below section describes the protection, use, and sharing of information, which consists of the following: ● Information in the medical record, which is held by the study site ● Information that is extracted during this study ("study data"), which is held by the study site, Roche, Roche affiliates, and Roche's representatives (people and companies who work for Roche) As part of this observational study, the Information will be copied from the medical records and recorded in a way to ensure that the patient Information is kept confidential throughout the observational study and thereafter. The study data will be labeled with a patient identification number (ID) that is unique to the patient and not related to or derived from Information that identifies the patient (such as his/her name, picture, or any other personally identifying information). Roche, Roche affiliates, and Roche's representatives will only have access to study data labeled with a patient ID number, except as described below. Patient's medical record, which includes personal information that can identify the patient, will not be accessed for the purposes of this study, except as described below: To make sure the study is being done properly or to check the quality of the data, the following people and groups of people will be granted direct access to the original medical records (i.e., they may look at and/or copy of the medical and personal information) without violating the confidentiality of patients data: ● Study monitors of Roche and/or IQVIA, a company hired by Roche to perform certain study activities ● The Institutional Review Board or Ethics Committee responsible for protecting the rights and safety of the patients who take part in research studies ● Regulatory authorities (government agencies involved in keeping research safe for people) Roche, Roche affiliates, and Roche's collaborators and licensees (people and companies who partner with Roche) may use study data labeled with patient ID number. Study data may also be shared with independent researchers or government agencies, but only after personal information that can identify the patients have been removed. Study data may be combined with other people's data and/or linked to other data extracted from *patient's medical records. Study data may be used to help better understand why people get diseases and how to best prevent, diagnose, and treat diseases, and to develop and provide access to new medicines, medical devices, and healthcare solutions. If the results from this study are published in a medical journal or presented at a scientific meeting, the patients will not be identified. Information from this study will be retained by the study site for 5 years after the end of the study or for the length of time required by applicable laws, whichever is longer. In addition, Roche will retain the study data for 25 years after the final study results have been reported or for the length of time required by applicable laws, whichever is longer.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Countries of Recruitment
Name
Health Conditions or Problems Studied
Condition
Code
Keyword
Interventions
Intervention
Description
Keyword
Primary Outcomes
Name
Time points
Measure
Key Secondary Outcomes
Name
Time points
Measure
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
With the reference of the Vanessa Study, please find attached the new Blank crf for the study as the previous one was decommissioned.
27/04/2023
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