Clinical trial NCT04375150: Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Official title: Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma (RCC)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 355
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with RCC

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With First Line Treatment Regimen
timeFrame: At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months
measure: Number of Participants With Monotherapy and Combination Therapy
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Time to First Line Therapy
timeFrame: From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months
measure: Duration of Treatment According to Each Line of Therapy
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants With Treatment Continuation
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants With Treatment Interruption
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Time to Treatment Interruption
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants With Treatment Switch or Augmentation
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants According to Lines of Therapy
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Number of Participants According to Their Status at End of Follow-up
timeFrame: At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)
measure: Time to Treatment Failure (TTF)
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Percentage of Participants With Treatment Discontinuation
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
measure: Percentage of Participants Alive at 3 Months
timeFrame: At 3 months (data collected and observed retrospectively over 35 months)
measure: Percentage of Participants Alive at 6 Months
timeFrame: At 3 months (data collected and observed retrospectively over 35 months)
measure: Percentage of Participants Alive at 12 Months
timeFrame: At 3 months (data collected and observed retrospectively over 35 months)
measure: Overall Survival
timeFrame: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer INC
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: