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A REGISTRY TO COLLECT CHARACTERISTICS AND OUTCOMES FROM PATIENTS WITH SOLID TUMORS PROFILED WITH A NEXT-GENERATION SEQUENCING TEST (WAYFIND-R)
Current status:
Approved
|
Date registered:
15/04/2024
Trial version(s)
History: 25/06/2022
History: 25/06/2022
History: 25/06/2022
History: 25/06/2022
History: 25/06/2022
History: 25/06/2022
Current: 25/06/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022105085
Protocol number
MX39897
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Not Applicable - The Registry will be conducted in several countries worldwide including EU countries like France
Type of registration
Prospective
Date of registration in national regulatory agency
27/08/2020
Primary sponsor
F. Hoffmann-La Roche Ltd
Primary sponsor: Country of origin
Switzerland
Public title
A REGISTRY TO COLLECT CHARACTERISTICS AND OUTCOMES FROM PATIENTS WITH SOLID TUMORS PROFILED WITH A NEXT-GENERATION SEQUENCING TEST (WAYFIND-R)
Acronym
WAYFIND-R
Scientific title
A REGISTRY TO COLLECT CHARACTERISTICS AND OUTCOMES FROM PATIENTS WITH SOLID TUMORS PROFILED WITH A NEXT-GENERATION SEQUENCING TEST (WAYFIND-R)
Acronym
WAYFIND-R
Brief summary of the study: English
This is an observational, non-interventional, prospective, multinational and multicenter solid tumor cancers registry. Patients with any type of malignant solid tumor will be targeted for enrolment. Patients who have undergone NGS testing no more than 3 months prior to the enrolment date will be included, irrespective of the availability of test results. All medicinal products used to treat solid tumor cancers (all oncology treatments) are considered studied medicinal products for this registry. The study has several objectives, the most prominent of which are: -To provide a platform to support the design and conduct of clinical and epidemiological research -To develop an evidence-generation platform to better understand health outcomes and cancer care processes -To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing Participants’ data will be abstracted from the medical records collected by the registry treating physician or medical staff and recorded on electronic case report forms (eCRFs). Data from participant medical records and notes should be entered on the eCRFs as soon as they become available, or at regular intervals and for all visits that occurred within every 6 months from the enrolment or previous visit until participant withdrawal or discontinuation of the site or the registry, whichever occurs first. Data on pregnancy should be reported using the paper pregnancy reporting form provided by the Sponsor. Additionally, at the time of the patient’s enrolment visit two baseline information forms will be collected: -A baseline physician information form on rationale/reason for ordering NGS testing and the reimbursement for the test (for each patient enrolled in the registry) -A baseline patient information form to collect, risk factors, confounders and effect modifiers including comorbidities and sociodemographic information that may not be present or well completed in patient medical records Due to the nature of this registry, it is currently not possible to determine the exact sample size; however, we aim to enroll around ≥15,000 patients by 2026 and beyond based on enrolment rate.
Brief summary of the study: Arabic
هذه الدراسة هي عبارة عن دراسة تسجيل رصدية غير تدخلية استطلاعية متعددة الجنسيات ومتعددة المراكز على الأورام السرطانية الصلبة. سيتم استهداف المرضى ممن يعانون من أي نوع من الأورام الصلبة الخبيثة. سيتم تضمين المرضى الذين خضعوا لاختبار تسلسل الجيل التَّالي قبل ما لا يزيد عن 3 أشهر من تاريخ التسجيل، بصرف النظر عن توفر نتائج الاختبار. تعتبر جميع المنتجات الدوائية المستخدمة لعلاج الأورام السرطانية الصلبة (جميع علاجات الأورام) منتجات طبية خاضعة للدراسة في دراسة التسجيل. للدراسة عدة أهداف، أبرز عناوينها هي: -توفير منصة لدعم تصميم وإجراء البحوث السريرية والوبائية -استحداث منصة لتوليد الأدلة لفهم النتائج الصحية وعمليات رعاية مرضى السرطان بشكل أفضل -توصيف العلاجات والمسار السريري للأورام السرطانية الصلبة في المرضى الذين خضعوا لاختبار تسلسل الجيل التَّالي سيتم استخراج بيانات المشاركين من السجلات الطبية التي جمعها الطبيب المعالج أو الطاقم الطبي بدراسة التسجيل والمسجلة في نماذج تقرير الحالة الإلكترونية (eCRFs). يجب إدخال البيانات المأخوذة من السجلات الطبية والملاحظات الخاصة بالمشاركين في نماذج تقرير الحالة الإلكترونية بمجرد توفرها، أو على فترات منتظمة ولجميع الزيارات التي حدثت خلال كل 6 أشهر من وقت التسجيل أو الزيارة السابقة حتى انسحاب المشارك أو توقف الموقع أو دراسة التسجيل، أيهم يحدث أولًا. يجب الإبلاغ عن البيانات المتعلقة بالحمل باستخدام النموذج الورقي للإبلاغ عن الحمل المُقَدَّم من الشركة الرَّاعية. بالإضافة إلى ذلك، في وقت زيارة تسجيل المريض، سيتم جمع نموذجي المعلومات الخاصين ببدء الدراسة: -نموذج معلومات الطبيب عند بدء الدراسة حول الأساس المنطقي/سبب طلب اختبار تسلسل الجيل التَّالي وسداد تكاليف الاختبار (لكل مريض مسجل في دراسة التسجيل) -نموذج معلومات المريض الخاص ببدء الدراسة لجمع عوامل الخطورة والعوامل المربكة ومُحَوِّرَات التأثير ومن ضمنها الأمراض المصاحبة والمعلومات الاجتماعية الديموجرافية التي قد لا تكون موجودة أو مكتملة بشكل جيد في السجلات الطبية للمريض نظرًا لطبيعة دراسة التسجيل هذه، لا يمكن حاليًّا تحديد حجم العينة بدقة؛ ومع ذلك، نهدف إلى تسجيل نحو ≥ 15000 مريض بحلول عام 2026 وما بعده بناءً على معدل التسجيل.
Health conditions/problem studied: Specify
The registry population will include adult patients who are diagnosed with solid tumor cancers (at any anatomical location) and at any stage of the disease.
Interventions: Specify
Non-interventional study
Key inclusion and exclusion criteria: Inclusion criteria
Patients must meet the following criteria for enrolment in this registry: - Patient is an adult (according to age of majority as defined by local regulations) - Patient is currently diagnosed with any type of solid tumor cancer, at any stage of the disease, at the enrolment date (informed consent date) - Patient has undergone NGS testing, no longer than 3 months prior to the enrolment date, irrespective of the availability of test results - Informed consent has been obtained from the patient or legally authorized representative, as per local regulations
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 the below exclusion criterion at the time of enrolment will not be enrolled in this registry: - Patient has a prior or current diagnosis of hematological malignancy
Type of Study
Type
Observational
Study model
Other
Study model: Specify model
Registry
Study model: Explain model
This is an observational, non-interventional, prospective, multinational and multicenter solid tumor cancers registry. As per the EMA discussion paper, a patient registry is an organized data collection system that uses observational methods to collect uniform data on a patient population that is followed over time (EMA 2018). Patients enrolled in this registry might be already enrolled in a clinical trial or might be offered participation in a clinical trial at the same time, as applicable per inclusion/exclusion criteria of the clinical trial. This registry will not be a product registry, as it aims to collect data on patients who are undergoing a variety of treatments for diverse solid tumors that are not predefined. Instead, enrolment is subject to the prescription of NGS within clinical practice, irrespective of the availability of test results.
Time perspective
Prospective
Time perspective: Explain time perspective
Observation Period for the participant: The term “observation period” is defined as the period spanning from the date of consent until the date of death, loss to follow-up, withdrawal of consent, registry closure by Sponsor or site withdrawal from the registry, whichever occurs first.
Target follow-up duration
2
Target follow-up duration: Unit
years
Number of groups/cohorts
1
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
15000
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
15/11/2022
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2024
Recruitment status
Pending
Date of completion
31/12/2024
IPD sharing statement plan
Yes
IPD sharing statement description
The Sponsor maintains confidentiality standards by coding each participant enrolled in the registry through assignment of a unique participant identification number. This means that participant names or other direct identifiers are not included in datasets that are transmitted to any Sponsor location. Data protection and privacy regulations will be followed in capturing, processing, storing and sharing participant data, in accordance with local applicable privacy and confidentiality requirements. An external anonymized data sharing plan that aligns with national regulations and EU GDPR (2016) (General Data Protection Regulation) will be developed. This will outline the mechanism of data sharing with relevant research parties who are interested in utilizing the data collected in this registry for conducting SDU studies. The data will be stored in a data warehouse after closing the registry. Participant medical information obtained by this registry is confidential and may be disclosed to third parties only as permitted by the ICF (or separate authorization for use and disclosure of personal health information) signed by the participant, unless permitted or required by law. Medical information may be given to a participant’s personal treating physician or other appropriate medical personnel responsible for the subject’s welfare, for treatment purposes. Data collected by this registry must be available for inspection upon request by representatives of national and local health authorities, Sponsor monitors, representatives, collaborators and the IRB/EC for each registry site, as appropriate.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Sources of Monetary or Material Support
Name
F. HOFFMANN-LA ROCHE LTD
Secondary Sponsors
Name
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hampig
Kourie
Hotel Dieu De France - ALFRED NACCACHE STREET 20631111 Beirut
Lebanon
01604000
hampig.kourie@hotmail.com
Hotel Dieu De France
Scientific
Hampig
Kourie
Hotel Dieu De France - ALFRED NACCACHE STREET 20631111 Beirut
Lebanon
01604000
hampig.kourie@hotmail.com
Hotel Dieu De France
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr. Hamig Kourie
Hematologist-Oncologist & Oncogeneticist
Approved
American University of Beirut
Dr. Hazem Assi
Oncologist
Approved
Hammoud University Hospital
Dr. Fadi Farhat
Oncologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
31/05/2022
Professor Sami Richa
cue@usj.edu.lb
+961-1-421 229
American University of Beirut Medical Center
06/03/2023
American University of Beirut IRB
irb@aub.edu.lb
+961 1 35 00 00 – Ext 5445
Hammoud Hospital University Medical Center
11/09/2023
Hammoud Hospital IRB
info@hhumc.org.lb
+961 7 723111
Countries of Recruitment
Name
Lebanon
Argentina
Austria
Brazil
Canada
Colombia
France
Greece
Hungary
Ireland
Mexico
Portugal
Spain
Thailand
Turkey
United Kingdom
Germany
Estonia
Philippines
Republic of Serbia
Slovenia
Viet Nam
Taiwan
Chile
Slovakia
India
South Africa
Poland
Egypt
United Arab Emirates
Saudi Arabia
Health Conditions or Problems Studied
Condition
Code
Keyword
Solid Tumors
Neoplasm of uncertain or unknown behaviour, unspecified (D48.9)
ALL SOLID TUMORS
Interventions
Intervention
Description
Keyword
Non-Interventional Study (Registry)
NA
NA
Primary Outcomes
Name
Time points
Measure
To provide a platform to support the design and conduct of clinical and epidemiological research
NA being that it's a registry
- Collect data that can inform future trial design and facilitate identification of potential trial populations - Provide a resource to identify, develop and qualify biomarkers, novel assessment tools and clinical endpoints - Provide a resource to support the conduct of disease-modeling studies
To develop an evidence-generation platform to better understand health outcomes and cancer care processes
NA being that it's a registry
- Provide a resource to inform how precision medicine tools are used and how they affect patient care in the real world - Provide a resource to generate evidence that can support clinical, regulatory and access decision-making - Provide a resource to identify and assess clinical practices that can improve the healthcare of affected individuals
To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing
NA being that it's a registry
- Collect data that describes the history of patients undergoing NGS testing - Collect data that can help identify the complex genomic landscape affecting the diagnosis and prognosis of solid tumor cancers and deepen the understanding of underlying biologic pathways - Collect data that can help identify sub-populations that may best benefit from precision medicine tools
Key Secondary Outcomes
Name
Time points
Measure
NA - It's a registry
NA
NA
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
Regarding the submission for the Wayfind R study, we have updated the "Centers/Hospitals Involved in the Study" and "Ethics Review" sections to reflect the approved site participating in the study. We have added approvals for Hotel Dieu de France and AUBMC for Protocol Amendment v4.0. The package was previously approved on LBCTR for the initial submission at Hammoud Hospital. For HDF, we received the initial approval with ICFs v2.1, and then a minor amendment was made to this version of the ICF, which was submitted for v2.2. For AUB, we received approval on ICF v2.2 and baseline patient information v2.1, which also underwent minor changes.
08/04/2024
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