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Trial details
A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma
Current status:
Approved
|
Date registered:
17/07/2020
|
Date last updated:
17/07/2020
Trial version(s)
History: 10/07/2020
Current: 10/07/2020
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Main Information
Primary registry identifying number
LBCTR2020074518
Protocol number
OPERA2020
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
10/07/2020
Primary sponsor
Pfizer
Primary sponsor: Country of origin
United Arab Emirates
Public title
A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma
Acronym
OPERA
Scientific title
A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma
Acronym
OPERA
Brief summary of the study: English
Background and objective: Renal cell carcinoma (RCC), the eighth most common malignancy affecting adults, accounts for around 4% of new cancer cases in the United States. It is the seventh most common cancer in men and the ninth most common in women. The targeted therapies with Tyrosine Kinase inhibitors (TKI) and immune-based treatments are important components of treatment for advanced kidney cancer. This study will be conducted to describe the pattern of use of TKI and/or immunotherapy treatment options whether as monotherapy or in combination regimen and to assess the potency of the therapy sequence in routine clinical practice. Methods: This is a regional, multicenter observational prospective study, to gather routine clinical practice data on the usage patterns and outcomes of immunotherapy and/or TKI, for metastatic RCC. One hundred eighty-five patients diagnosed with metastatic renal cell carcinoma and will be on immunotherapy and/or TKI in this observational study will be enrolled over three years. Assessment: Efficacy parameters include response to treatment, duration of progression-free survival, duration of overall survival, partial response, time to response, Karnofski Performance Status, and tumor assessment. Safety parameters will include laboratory data, ECG, adverse events, and serious adverse events as pruritus, diarrhea, and organ toxicity as liver, lungs, kidneys, thyroid, and neurologic. Data will be recorded at different at baseline, during treatment at 3, 6,12, and 36 months, and at every follow-up once yearly after the last administration of immunotherapy and TKI until the last follow-up.
Brief summary of the study: Arabic
الخلفية والهدف: سرطان الخلايا الكلوية (RCC) : انه ثامن أكثر الأورام الخبيثة شيوعًا التي تصيب البالغين ، يمثل حوالي 4 ٪ من حالات السرطان الجديدة في الولايات المتحدة. وهو سابع أكثر أنواع السرطان شيوعًا بين الرجال والتاسع الأكثر شيوعًا بين النساء. تعد العلاجات المستهدفة باستخدام مثبطات التيروزين كيناز (TKI) و العلاجات القائمة على المناعة مكونات مهمة لعلاج سرطان الكلى المتقدم. سيتم إجراء هذه الدراسة لوصف نمط استخدام TKI و / أو خيارات العلاج المناعي سواء كعلاج وحيد أو في نظام مشترك لتقييم فعالية تسلسل العلاج في الممارسة السريرية الروتينية. الطرق: هذه دراسة استطلاعية رصدية إقليمية متعددة المراكز لجمع بيانات الممارسة السريرية الروتينية حول أنماط ونتائج استخدام العلاج المناعي و / أو TKI لـ سرطان الخلايا الكلوية المنتشر. مائة وخمسة وثمانون مريضا تم تشخيصهم بسرطان الخلايا الكلوية المنتشر ويخضعون للعلاج المناعي و / أو TKI في هذه الدراسة المستقبلية سيتم تسجيلهم على مدى ثلاث سنوات. التقييم: تشمل معلمات الفعالية الاستجابة للعلاج ، ومدة البقاء على قيد الحياة الخالية من التقدم ، ومدة البقاء الكلي ، والاستجابة الجزئية ، ووقت الاستجابة ، وحالة أداء Karnofski ، وتقييم الورم. تشمل معايير الأمان بيانات المختبر ، وتخطيط القلب ، والأحداث السلبية ، والأحداث السلبية الخطيرة مثل الحكة ، والإسهال ، وتسمم الأعضاء مثل الكبد والرئتين والكلى والغدة الدرقية والعصبية. سيتم تسجيل البيانات بشكل مختلف عند خط الأساس ، وأثناء العلاج في 3 و 6 و 12 و 36 شهرًا ، وفي كل متابعة مرة واحدة سنويًا بعد آخر إدارة للعلاج المناعي و TKI حتى آخر متابعة.
Health conditions/problem studied: Specify
Patients with: - histologically confirmed metastatic renal cell cancer - treated by immunotherapy and/or TKI
Interventions: Specify
Any immunotherapy and TKI prescribed for the management of mRCC as per FDA/EMA approval
Key inclusion and exclusion criteria: Inclusion criteria
- Patients ≥ 18 years old - Histologically confirmed metastatic renal cell cancer - Patients treated by immunotherapy and/or TKI - Signed informed consent form obtained prior to study entry only for living patients
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
80
Key inclusion and exclusion criteria: Exclusion criteria
- History of another malignancy within the past 5 years except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix - Pregnancy - Current participation in another clinical trial
Type of Study
Type
Observational
Study model
Case-Only
Study model: Explain model
Pure observational study
Time perspective
Prospective
Time perspective: Explain time perspective
- First Patient in: 01 July 2020 - Last Patient in: 30 June 2023 - Last Patient out: 01 January 2024 - Estimated enrolment duration: 3 years - Estimated follow-up duration: Until death, loss to follow-up, or study termination. - Database lock planned date: 01 January 2024
Target follow-up duration
6
Target follow-up duration: Unit
months
Number of groups/cohorts
4
Biospecimen retention
Samples without DNA
Biospecimen description
Metastatic Cell Carcinoma
Target sample size
185
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/07/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
01/01/2024
Recruitment status
Pending
Date of completion
01/01/2024
IPD sharing statement plan
No
IPD sharing statement description
Summary Results Reporting
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
NA
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Marwan
Ghosn
Hotel Dieu
Lebanon
01613395
marwan.ghosn@usj.edu.lb
Principle Investigator
Scientific
Marwan
Ghosn
Hotel Dieu
Lebanon
01613395
marwan.ghosn@usj.edu.lb
Principle Investigator
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu de France, Beirut
Prof. Marwan Ghosn
Oncology/ Hematology
Approved
Hammoud Hospital University Medical Center, Saida
Prof. Fadi Farhat
Oncology/ Hematology
NA
Sheikh Khalifa Specialty Hospital ( SKSH )-Ras al Khaimah
Dr. Hassan Jaafar
Oncology/ Hematology
NA
King Faisal Specialty Hospital- Jeddah
Prof. Jamal Zekri
Medical Oncology
NA
King Saud bin Abdul Aziz -Jeddah
Prof. Mubarak Mansour
Medical Oncology
NA
Kuwait Cancer Control Center
Dr. Ehab Abdou
Medical Oncology
NA
King Hussein Cancer Center - KHCC
Dr. Samer Salah
Medical Oncology
NA
Cairo University Hospitals
Prof. Emad Hamada
Medical Oncology
NA
Kasr Al Aini Hospital
Prof. Hamdy Abdel Azim
Medical Oncology
NA
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
30/06/2020
Nancy Alam
nancy.alam@usj.edu.lb
01421229
Countries of Recruitment
Name
Lebanon
Saudi Arabia
United Arab Emirates
Egypt
Kuwait
Jordan
Health Conditions or Problems Studied
Condition
Code
Keyword
renal cell carcinoma
Carcinoma in situ of other specified sites (D09.7)
renal cell carcinoma
Interventions
Intervention
Description
Keyword
Immunotherapy and/or TKI
This is a regional, multicenter observational prospective study, to obtain routine clinical practice data on the usage patterns and outcomes (safety and effectiveness) of immunotherapy and/or TKI, for metastatic renal cell carcinoma in real-life practice
Immunotherapy and/or TKI
Primary Outcomes
Name
Time points
Measure
To describe the efficacy of immunotherapy and/or TKI alone for the treatment of metastatic renal cell carcinoma in terms of progression-free survival (PFS) and overall survival (OS)
one and three years
Progression-free survival and duration of overall survival
Assess the potency of the sequence therapy in terms of first, second, and third line therapy with the current real-world clinical practice
one and three years
Overall response rate, time to response and tumor assessment
Key Secondary Outcomes
Name
Time points
Measure
To describe the safety and toxicity profile of immunotherapy and/or TKI for fatigue, rash, nausea, pruritus and diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic
one, three, six, twelve, and 36 months post treatment, and at 1st relapse
Lab data, ECG, Adverse events and serious adverse events
To compare patients’ profile if the therapy is administered as first, second, or third line treatment options at one, three, six, twelve, and 36 months post treatment, and at 1st relapse
one, three, six, twelve, and 36 months post treatment, and at 1st relapse
Serious Adverse Events as pruritus, diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic examination
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
Download as PDF
Save a PDF copy of the summary of the trial