Kidney CancerNCT04472663
Participant Reported Outcomes and Treatment Experiences in Kidney Cancer
An observational study of Kidney Cancer, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 9 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be included if they have primary diagnosis of aRCC, age ≥18 years, with medical history available from date of aRCC diagnosis to most recent or current therapy. For Cohort 1, patients will be eligible if they had initiated 1LOT between April 2018 - March 2020. For Cohort 2, patients will be eligible if they are about to initiate 1LOT, must be willing to sign the informed consent form (ICF), where required, and complete the humanistic burden assessment at baseline and subsequent follow-ups.
Who may be able to join
- Cohort 1
- Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC
- Medical history must be available from date of aRCC diagnosis
- Initiated 1LOT between April 2018 - March 2020
- Cohort 2:
- Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC Stage III unresectable) or metastatic RCC (AJCC Stage IV).
- Medical history must be available from date of aRCC diagnosis.
- Initiate 1LOT.
Who cannot join
- Currently enrolled in a clinical trial for treatment of aRCC
- Any prior malignancy active within the previous 3 year, except for locally curable cancers that have been cured
- Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant therapy (Cohort 2 only)
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)
The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating first-line systemic therapy.
- Conditions
- Kidney Cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Retrospective Long-term Chart Review | |
| Cohort 2 | Prospective-Retrospective Chart Review and Humanistic Burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 36 months
Disease-related symptoms as measured by change from baseline in FKSI-DRS
Measured: Up to 36 months
Secondary outcomes (17)
Demographic characteristics of aRCC patients as measured by continuous statistics: Age
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by categorical statistics: Gender
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Height
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC
Measured: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)
Measured: Up to 36 months
Sequence of therapy events including treatment modalities
Measured: Up to 36 months
Time to therapy initiation of LOT
Measured: Up to 36 months
Rationale for therapy selection
Measured: Up to 36 months
Switching and/or discontinuation rate
Measured: Up to 36 months
Drug use characteristics including dosing regimens: Drugs included in each course of therapy
Measured: Up to 36 months
Drug use characteristics including dosing regimens : Formulations
Measured: Up to 36 months
Drug use characteristics including dosing regimens : Dose
Measured: Up to 36 months
Drug use characteristics including dosing regimens : Frequency of administration
Measured: Up to 36 months
Drug use characteristics including dosing regimens: Duration of therapy
Measured: Up to 36 months
Drug use characteristics including dosing regimens : Number of cycles planned and administered
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start6 Jul 2020
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472663
- Sponsor's protocol ID
- CA209-7DK
- Status last verified
- Jan 2022
- First submitted
- 14 Jul 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)
- ClinicalTrials.gov ID
- NCT04472663
- Acronym / sponsor ID
- CA209-7DK
- Conditions
- Kidney Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating first-line systemic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Retrospective Long-term Chart Review |
| Cohort 2 | – | –Prospective-Retrospective Chart Review and Humanistic Burden |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be included if they have primary diagnosis of aRCC, age ≥18 years, with medical history available from date of aRCC diagnosis to most recent or current therapy. For Cohort 1, patients will be eligible if they had initiated 1LOT between April 2018 - March 2020. For Cohort 2, patients will be eligible if they are about to initiate 1LOT, must be willing to sign the informed consent form (ICF), where required, and complete the humanistic burden assessment at baseline and subsequent follow-ups.
Key inclusion criteria (8 listed)
- Cohort 1
- Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC
- Medical history must be available from date of aRCC diagnosis
- Initiated 1LOT between April 2018 - March 2020
- Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC Stage III unresectable) or metastatic RCC (AJCC Stage IV).
Key exclusion criteria (4 listed)
- Currently enrolled in a clinical trial for treatment of aRCC
- Any prior malignancy active within the previous 3 year, except for locally curable cancers that have been cured
- Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant therapy (Cohort 2 only)
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: Up to 36 months
Disease-related symptoms as measured by change from baseline in FKSI-DRS
Time frame: Up to 36 months
17 secondary outcomes
Demographic characteristics of aRCC patients as measured by continuous statistics: Age
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by categorical statistics: Gender
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Height
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC
Time frame: Up to 36 months
Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)
Time frame: Up to 36 months
Sequence of therapy events including treatment modalities
Time frame: Up to 36 months
Time to therapy initiation of LOT
Time frame: Up to 36 months
Rationale for therapy selection
Time frame: Up to 36 months
Switching and/or discontinuation rate
Time frame: Up to 36 months
Drug use characteristics including dosing regimens: Drugs included in each course of therapy
Time frame: Up to 36 months
Drug use characteristics including dosing regimens : Formulations
Time frame: Up to 36 months
Drug use characteristics including dosing regimens : Dose
Time frame: Up to 36 months
Drug use characteristics including dosing regimens : Frequency of administration
Time frame: Up to 36 months
Drug use characteristics including dosing regimens: Duration of therapy
Time frame: Up to 36 months
Drug use characteristics including dosing regimens : Number of cycles planned and administered
Time frame: Up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Cancer, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.