ID

45760

Description

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.

Link

dbGaP-study=phs001141

Keywords

Versions (1)
  1. 6/16/23 6/16/23 - Chiara Middel
Copyright Holder

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

Uploaded on

June 16, 2023

DOI

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License

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

English

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 forms  
  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
Description

pht005599

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

SUBJECT_ID

Data type

string

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

CONSENT

Data type

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]
Description

SUBJECT_SOURCE

Data type

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
Description

SOURCE_SUBJECT_ID

Data type

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
Description

AFFECTION_STATUS

Data type

text

Alias
UMLS CUI [1,1]
C3274646 (Participant Case or Control Status)
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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 forms
  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
Type
Description | Question | Decode (Coded Value)
Data type
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)
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