Prevalence of HRR-related Genes Mutations and Prognosis in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients in Real World Setting
NCT ID: NCT04425200
Last Updated: 2021-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
205 participants
OBSERVATIONAL
2020-07-29
2020-12-18
Brief Summary
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\<Methods\> Study design: multi-center, prospective cohort study
Data Source(s):
In this study, 155 patients (expected recruitment patients: maximum 205 patients) will be enrolled from approximately 20\~30 sites in Japan. Study Population: mCRPC patients who diagnosed between 2014 and 2018. Exposure(s): N.A Outcome(s): Prevalence of tissue HRR-related gene mutations, clinical outcomes such as Over survival and PSA-PFS, Treatment pattern
Sample Size Estimations:
The target population is 155 patients based on the prevalence of HRR-related genes (BRCA1, BRCA2 and ATM) which is reported in previous global study (PROfound study).
Statistical Analysis:
This study is not intended to verify specific hypotheses, and the results are evaluated descriptively. There is no plan of interim analyses before the final analysis.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients who provided informed consent. If the patient has died, opt-out will be applicable.
* Patients who are diagnosed as mCRPC between January 1st in 2014 and December 31st in 2018.
* Patients who have a FFPE tumor sample (primary or metastatic) with Formalin Neutral Buffer Solution.
* Patients which the investigator judges to secure the enough amount of tumor samples for future laboratory test.
Exclusion Criteria
* Patients who have an only FFPE primary tumor sample (primary or metastatic) with unbuffered formalin including acidic formalin.
* Patients who have taken an investigational medical product for prostate cancer from Jan 1st , 2014 to Dec 31st 2020.
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki, Aomori, Japan
Jikei University Kashiwa Hospital
Kashiwa, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
National Hospital Organization Kure Medical Center
Kure, Hiroshima, Japan
Hakodate Goryoukaku Hospital
Hakodate, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Hiragi, Kagawa-ken, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Tottori University Hospital
Yonago, Tottori, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Chiba University Hospital
Chiba, , Japan
Gifu University Hospital
Gifu, , Japan
Kyoto Prefectural University of Medicine
Kyoto, , Japan
University of Miyazaki Hospital
Miyazaki, , Japan
Okayama University Hospital
Okayama, , Japan
Countries
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Related Links
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Other Identifiers
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D081LR00002
Identifier Type: -
Identifier Source: org_study_id
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