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ID

45760

Descrizione

Principal Investigator: Manish Kohli, MD, Mayo Clinic, Rochester, MN, USA MeSH: Prostatic Neoplasms, Castration-Resistant,Prostatic Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001141 The Prostate Cancer Medically Optimized Genome-Enhanced Therapy (PROMOTE) study uses genetic clues in castration-resistant prostate cancer that may identify an individualized treatment approach for men with the disease. Understanding the molecular biology behind castration-resistant prostate cancer has led to more treatment options, but there are still no definite conclusions about which specific drug best treats patients - maximum suppression of cancer growth while minimizing side effects. The PROMOTE study explores the genetic characteristics of each tumor to predict these treatment paradigms for the future, resulting in more effective and less toxic options for patients. Our long-term goal is to improve treatments for men with advanced prostate cancer by using genomic sequencing to increase life span and quality of life. We also will uncover novel vulnerable targets in the cancer genome that may provide new drug therapies. **PARTICIPATION** Eligible participants are men: - With castration-resistant prostate cancer or prostate cancer not responding to hormone treatments - About to begin abiraterone acetate therapy - Agreeable to undergoing two tumor biopsies During the study, participants travel to Mayo Clinic for an initial biopsy (before beginning abiraterone acetate) and a second biopsy approximately three months later. The cell tissue collected is analyzed to identify gene alterations in the tumor that could eventually be targeted with treatments. Tissue is preserved for future research. Participants can continue to be treated by their local cancer care team during this period and beyond. In addition, the Mayo team carefully monitors participants' cancer via follow-up studies and the genetic signature of tumors that were biopsied so that patients may benefit from future treatments.

collegamento

dbGaP-study=phs001141

Keywords

versioni (1)
  1. 16/06/23 16/06/23 - Chiara Middel
Titolare del copyright

Manish Kohli, MD, Mayo Clinic, Rochester, MN, USA

Caricato su

16 giugno 2023

DOI

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Licenza

Creative Commons BY 4.0
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    dbGaP phs001141 PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE)

    Inglese

    Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.

    5 moduli  
    1. StudyEvent: SEV1
      1. Eligibility Criteria
      2. Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      3. Subject ID, sample ID, sample source, source sample ID, and sample use variable obtained from Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      4. Subject ID, age, race, composite endpoint for progression after 12 weeks of abiraterone acetate chemotherapy, and sex of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      5. Sample ID, body site where sample was obtained, analyte type, primary or metastatic tumor, primary tumor location, tumor stage, tumor treatment, treatment post visit, histological type, sequence center, and body site category where sample was collected [bone or tissue] of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    pht005599
    Descrizione

    pht005599

    Alias
    UMLS CUI [1,1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Subject ID
    Descrizione

    SUBJECT_ID

    Tipo di dati

    string

    Alias
    UMLS CUI [1,1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Consent group as determined by DAC
    Descrizione

    CONSENT

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C0441833 (Groups)
    SNOMED
    246261001
    Source repository where subjects originate [Mayo Clinic Cancer Center]
    Descrizione

    SUBJECT_SOURCE

    Tipo di dati

    string

    Alias
    UMLS CUI [1,1]
    C3847505 (Repository)
    LOINC
    LP182360-0
    UMLS CUI [1,2]
    C0449416 (Source)
    SNOMED
    260753009
    LOINC
    LP21212-3
    UMLS CUI [1,3]
    C0681850 (Study Subject)
    Subject ID used in the Source Repository
    Descrizione

    SOURCE_SUBJECT_ID

    Tipo di dati

    string

    Alias
    UMLS CUI [1,1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    UMLS CUI [1,2]
    C3847505 (Repository)
    LOINC
    LP182360-0
    UMLS CUI [1,3]
    C0449416 (Source)
    SNOMED
    260753009
    LOINC
    LP21212-3
    Case control status of the subject
    Descrizione

    AFFECTION_STATUS

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3274646 (Participant Case or Control Status)
    Ritorna all'inizio della pagina

    Similar models

    Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.

    5 moduli
    1. StudyEvent: SEV1
      1. Eligibility Criteria
      2. Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      3. Subject ID, sample ID, sample source, source sample ID, and sample use variable obtained from Subject ID, consent group, subject source, source subject ID, and affection status of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      4. Subject ID, age, race, composite endpoint for progression after 12 weeks of abiraterone acetate chemotherapy, and sex of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
      5. Sample ID, body site where sample was obtained, analyte type, primary or metastatic tumor, primary tumor location, tumor stage, tumor treatment, treatment post visit, histological type, sequence center, and body site category where sample was collected [bone or tissue] of participants with castration resistant prostate cancer and involved in the "PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE) of Castration Resistant Prostate Cancer (CRPC) Patients Treated with Abiraterone Acetate" project.
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    pht005599
    C3846158 (UMLS CUI [1,1])
    SUBJECT_ID
    Item
    Subject ID
    string
    C2348585 (UMLS CUI [1,1])
    Item
    Consent group as determined by DAC
    text
    C0021430 (UMLS CUI [1,1])
    C0441833 (UMLS CUI [1,2])
    CONSENT
    Code List
    Consent group as determined by DAC
    CL Item
    General Research Use (GRU) (1)
    C0021430 (UMLS CUI [1,1])
    C0242481 (UMLS CUI [1,2])
    SUBJECT_SOURCE
    Item
    Source repository where subjects originate [Mayo Clinic Cancer Center]
    string
    C3847505 (UMLS CUI [1,1])
    C0449416 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [1,3])
    SOURCE_SUBJECT_ID
    Item
    Subject ID used in the Source Repository
    string
    C2348585 (UMLS CUI [1,1])
    C3847505 (UMLS CUI [1,2])
    C0449416 (UMLS CUI [1,3])
    Item
    Case control status of the subject
    text
    C3274646 (UMLS CUI [1,1])
    AFFECTION_STATUS
    Code List
    Case control status of the subject
    CL Item
    Control (1)
    C3274648 (UMLS CUI [1,1])
    CL Item
    Case (2)
    C3274647 (UMLS CUI [1,1])
    CL Item
    Other (3)
    Ritorna all'inizio della pagina 

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