NCT05168436

Brief Summary

The purpose of this observational study is to determine patients' and professionals' preferences for the characteristics (attributes) of the treatment for Renal cell carcinoma (RCC) in Spain and Portugal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
Last Updated

December 23, 2021

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

October 22, 2021

Last Update Submit

December 8, 2021

Conditions

Keywords

OPDIVO®NivolumabPreferenceRCC

Outcome Measures

Primary Outcomes (2)

  • Utility: Renal cell carcinoma (RCC) participants' preferences

    Utility (preference score) derived for a treatment alternative choice (scenario)

    At Baseline

  • Utility: Oncologists' preferences

    Utility (preference score) derived for a treatment alternative choice (scenario)

    At Baseline

Secondary Outcomes (23)

  • Distribution of socio-demographic characteristics of Renal cell carcinoma (RCC) participants: Age

    At Baseline

  • Distribution of clinical characteristics of RCC participants: Time since RCC diagnosis

    At Baseline

  • Distribution of socio-demographic characteristics of RCC participants: Place of residence

    At Baseline

  • Distribution of socio-demographic characteristics of RCC participants: Gender

    At Baseline

  • Distribution of socio-demographic characteristics of RCC participants: Economic status (income)

    At Baseline

  • +18 more secondary outcomes

Study Arms (2)

Cohort 1

Participants with renal cell carcinoma (RCC) treated with nivolumab

Cohort 2

Oncologists with expertise in renal cancer from Spain and Portugal

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with diagnosis of Renal Cell Carcinoma (RCC) from a total of eight to eleven hospitals (6-8 located in Spain and 2-3 in Portugal) and oncologists with expertise in renal cancer from Spain and Portugal will participate in the study.

You may qualify if:

  • The oncologist is currently working in a Spanish or Portuguese public hospital.
  • The oncologist has at least 2 years of experience in the management of participants with Renal Cell Carcinoma (RCC).
  • The oncologist has agreed to participate in the study.
  • The participant has received or is currently receiving pharmacological treatment for RCC;
  • The participant has provided the informed consent to participate in the study.
  • The participant must be able to read, understand and complete the survey instrument according to the judgment of the responsible physician.

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Castellon, 12071, Spain

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

December 23, 2021

Study Start

August 5, 2019

Primary Completion

July 13, 2020

Study Completion

July 13, 2020

Last Updated

December 23, 2021

Record last verified: 2021-12

Locations