Treatment Patterns in Metastatic Prostate Cancer
2018년 1월 24일 업데이트: Bayer
Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives).
Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective).
The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
연구 개요
연구 유형
관찰
등록 (실제)
565
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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New Jersey
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Whippany, New Jersey, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
45년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
샘플링 방법
비확률 샘플
연구 인구
Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
설명
Inclusion Criteria:
- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:
- At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
- At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.
Exclusion Criteria:
- Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
- Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
- Patients who had a SRE in the 12-month pre-index period.
- Subjects without continuous enrollment for at least 12 months before the index date.
- Subjects without continuous eligibility for at least 6 months after the index date.
- Subjects that are female.
- Subjects that have negative costs.
- Subjects that are less than 45 years of age on the index date.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Treatment patterns, healthcare resource utilization and costs
Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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Mortality
Part 2 - Assessment of mortality.
The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population.
The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.
All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period.
Additionally, all subjects must be continuously enrolled for at least 12 months before the index date.
Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).
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Retrospective claims analysis.
Descriptive analyses of treatment patterns.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Distribution of treatment types among lines of therapy
기간: Up to 6 months
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Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Time to treatment (days)
기간: Up to 6 months
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Up to 6 months
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Duration of treatment (days)
기간: Up to 6 months
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Up to 6 months
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Number of patients on each drug or drug combination
기간: Up to 6 months
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Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
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Up to 6 months
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Number of inpatient visits per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Length of hospital stay (days) among those with an inpatient visit
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of outpatient visits per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of emergency room (ER) visits per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of physician office visits per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of medication prescriptions per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of patients by provider type
기간: Upto 6 month post index period
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Upto 6 month post index period
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Number of claims per patient
기간: Upto 6 month post index period
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Upto 6 month post index period
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Total costs of healthcare
기간: Upto 6 month post index period
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Upto 6 month post index period
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Medical costs of healthcare
기간: Upto 6 month post index period
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Upto 6 month post index period
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Pharmacy costs of healthcare
기간: Upto 6 month post index period
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Upto 6 month post index period
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Per-patient-per-month (PPPM)) costs of healthcare
기간: Upto 6 month post index period
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Upto 6 month post index period
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Mortality rate
기간: Up to 6 months
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Up to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Opioid/analgesic use among lines of therapy(Y/N)
기간: Up to 6 months
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Opioid and analgesics use among lines of therapy (e.g.
1st, 2nd, 3rd)
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Up to 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 10월 31일
기본 완료 (실제)
2017년 1월 19일
연구 완료 (실제)
2017년 1월 19일
연구 등록 날짜
최초 제출
2016년 3월 16일
QC 기준을 충족하는 최초 제출
2016년 3월 31일
처음 게시됨 (추정)
2016년 4월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 1월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 1월 24일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 18695
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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