Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC

May 14, 2024 updated by: Pfizer

Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.

The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10017
        • Pfizer Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with RCC

Description

Inclusion Criteria:

  • Age 20 years or older in the year of the index first line therapy prescription.

    • 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.
    • 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)
    • Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.
    • Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data

Exclusion Criteria:

  • Received advanced treatment prior to the study index date.

    • Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.
    • Only one RCC diagnosis in the 12 months prior or one mont post index date.
    • Patients with data for analysis (< 3 months post index date)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with advanced renal cell carcinoma (RCC)
Drug: Tyrosine kinase inhibitor (TKI)
TKIs
Drug: Immuno-oncology (IO)
IOs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With First Line Treatment Regimen
Time Frame: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
Number of Participants With Monotherapy and Combination Therapy
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Time to First Line Therapy
Time Frame: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months
Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.
From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months
Duration of Treatment According to Each Line of Therapy
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants With Treatment Continuation
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Treatment continuation was considered when there was no more than (>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants With Treatment Interruption
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Time to Treatment Interruption
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Time from index medication to treatment discontinuation for those within treatment interruptions (>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants With Treatment Switch or Augmentation
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants According to Lines of Therapy
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Number of Participants According to Their Status at End of Follow-up
Time Frame: At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)
Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.
At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)
Time to Treatment Failure (TTF)
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Percentage of Participants With Treatment Discontinuation
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Percentage of Participants Alive at 3 Months
Time Frame: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 3 months is reported in this outcome measure.
At 3 months (data collected and observed retrospectively over 35 months)
Percentage of Participants Alive at 6 Months
Time Frame: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 6 months is reported in this outcome measure.
At 3 months (data collected and observed retrospectively over 35 months)
Percentage of Participants Alive at 12 Months
Time Frame: At 3 months (data collected and observed retrospectively over 35 months)
Percentage of participants who were alive at 12 months is reported in this outcome measure.
At 3 months (data collected and observed retrospectively over 35 months)
Overall Survival
Time Frame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.
From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6181232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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