A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma

A Prospective Observational study to describe the pattern and effectiveness of the utilization of different treatment options for Metastatic Renal Cell Carcinoma - OPERA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

LBCTR

Registry ID

LBCTR2020074518

Enrollment

185

Registered

2021-11-11

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with: - histologically confirmed metastatic renal cell cancer - treated by immunotherapy and/or TKI renal cell carcinoma

Interventions

Any immunotherapy and TKI prescribed for the management of mRCC as per FDA/EMA approval

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

Immunotherapy and/or TKI

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Name: 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);Timepoints: one and three years;Measure: Progression-free survival and duration of overall survival;Name: Assess the potency of the sequence therapy in terms of first, second, and third line therapy with the current real-world clinical practice;Timepoints: one and three years;Measure: Overall response rate, time to response and tumor assessment	—

Measure

Time frame

Name: 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);Timepoints: one and three years;Measure: Progression-free survival and duration of overall survival;Name: Assess the potency of the sequence therapy in terms of first, second, and third line therapy with the current real-world clinical practice;Timepoints: one and three years;Measure: Overall response rate, time to response and tumor assessment

—

Secondary

Measure	Time frame
Name: 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;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Lab data, ECG, Adverse events and serious adverse events ;Name: 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;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Serious Adverse Events as pruritus, diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic examination	—

Measure

Time frame

Name: 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;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Lab data, ECG, Adverse events and serious adverse events ;Name: 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;Timepoints: one, three, six, twelve, and 36 months post treatment, and at 1st relapse;Measure: Serious Adverse Events as pruritus, diarrhea and organ toxicity as liver, lungs, kidneys, thyroid and neurologic examination

—

Countries

Egypt, Jordan, Kuwait, Lebanon, Saudi Arabia, United Arab Emirates

Contacts

Public ContactMarwan Ghosn

Principle Investigator

marwan.ghosn@usj.edu.lb01613395

Outcome results

None listed

Source: LBCTR (via WHO ICTRP) · Data processed: Feb 7, 2026