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OpenTrials
Completed

NCT Number: NCT04375150

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

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

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer INC

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tyrosine kinase inhibitor (TKI)

Drug

TKIs

Immuno-oncology (IO)

Drug

IOs

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 5, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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