ID

40819

Beschrijving

Molecular Phenotype Changes and Personalized Treatment for CRPC; ODM derived from: https://clinicaltrials.gov/show/NCT02208583

Link

https://clinicaltrials.gov/show/NCT02208583

Trefwoorden

Versies (1)
  1. 19-05-20 19-05-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 mei 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
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Eligibility Hormone Refractory Prostate Cancer NCT02208583

Engels

Eligibility Hormone Refractory Prostate Cancer NCT02208583

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18 years and older;
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with crpc according to european association of urology diagnostic criteria ;
Beschrijving

Prostatic Cancer, Castration-Resistant

Datatype

boolean

Alias
UMLS CUI [1]
C3658266
3. vital organs functions including bone marrow, heart, liver, kidney are normal;
Beschrijving

Organ function | Bone Marrow function | Cardiac function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232164
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0232804
4. complete pathological specimens including newly diagnosed with prostate cancer and disease progress to crpc: ① biopsies or surgical specimens (tissue bank or wax block preserved specimens) at diagnosis ; ② re-biopsy specimens,transurethral prostatectomy (turp) specimens, metastases palliative surgical specimens (tissue bank or wax block preserved specimens) after progress to crpc; ③ amount sufficient sample for dna extraction and quality control by up to standard (a) sample type: none rna degradation and pollution-free dna samples; (b) the amount of the sample (single): ≥
Beschrijving

|

Datatype

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600139
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1328504
UMLS CUI [3]
C0005558
UMLS CUI [4]
C1647891
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C0205341
UMLS CUI [5,3]
C0370003
UMLS CUI [6,1]
C0040771
UMLS CUI [6,2]
C0370003
UMLS CUI [7,1]
C0027627
UMLS CUI [7,2]
C1647891
UMLS CUI [7,3]
C1285530
UMLS CUI [8,1]
C0370003
UMLS CUI [8,2]
C3839098
UMLS CUI [9]
C1561524
UMLS CUI [10,1]
C1257756
UMLS CUI [10,2]
C0370003
UMLS CUI [10,3]
C0332197
UMLS CUI [11,1]
C0332197
UMLS CUI [11,2]
C0012854
UMLS CUI [11,3]
C0370003
UMLS CUI [12,1]
C1265611
UMLS CUI [12,2]
C0370003
250ng (using agilent liquid platform); (c) sample concentration: ≥ 50 ng / μl (using agilent liquid platform); (d) sample purity: od 260/280 = 1.8 ~ 2.0 );
Beschrijving

Sample Concentration measurement | Sample Purity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1446561
UMLS CUI [2,1]
C0370003
UMLS CUI [2,2]
C1882508
5. then we perform following tests when patients meet the above criteria: ①histological analysis: hematoxylin-eosin(he) staining ②immunohistochemistry(ihc) staining ③ 48 carcinomas associated exon sequencing
Beschrijving

Hematoxylin and eosin stain method | Immunohistochemistry | Sequencing of exon of gene

Datatype

boolean

Alias
UMLS CUI [1]
C0523207
UMLS CUI [2]
C0021044
UMLS CUI [3]
C2733343
6. after performing the above test, enter treatment group ① docetaxel & prednisone(dp) : with high psa and no gene mutation; ② dp + targeted drugs: with high psa and gene mutations; ③ cisplatin & etoposide(ep) : low psa and no gene mutation; ④ ep +
Beschrijving

Treatment Group | docetaxel | Prednisone | PSA High | Gene Mutation Absent | Treatment Group | docetaxel | Prednisone | Drugs Targeted | PSA High | Gene Mutation | Treatment Group | Cisplatin | Etoposide | PSA low | Gene Mutation Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0441833
UMLS CUI [2]
C0246415
UMLS CUI [3]
C0032952
UMLS CUI [4,1]
C0138741
UMLS CUI [4,2]
C0205250
UMLS CUI [5,1]
C0596611
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0441833
UMLS CUI [7]
C0246415
UMLS CUI [8]
C0032952
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C1521840
UMLS CUI [10,1]
C0138741
UMLS CUI [10,2]
C0205250
UMLS CUI [11]
C0596611
UMLS CUI [12,1]
C0087111
UMLS CUI [12,2]
C0441833
UMLS CUI [13]
C0008838
UMLS CUI [14]
C0015133
UMLS CUI [15,1]
C0138741
UMLS CUI [15,2]
C0205251
UMLS CUI [16,1]
C0596611
UMLS CUI [16,2]
C0332197
targeted drug: low psa and gene mutations.
Beschrijving

Treatment Group | Etoposide | Drugs Targeted | PSA low | Gene Mutation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0441833
UMLS CUI [2]
C0015133
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1521840
UMLS CUI [4,1]
C0138741
UMLS CUI [4,2]
C0205251
UMLS CUI [5]
C0596611
7. all patients enrolled in draw peripheral blood samples 7.5ml and detect circulating tumor cells (ctc) , monitoring efficacy.
Beschrijving

Peripheral blood Sample | Circulating Neoplastic Cells

Datatype

boolean

Alias
UMLS CUI [1,1]
C0229664
UMLS CUI [1,2]
C0370003
UMLS CUI [2]
C0027625
8. willing and able to comply with the program during the study period. 9 before entering clinical trials to provide written informed consent form, and the patient has to know you can withdraw from the study at any time in the study, and without any loss.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
10. agrees to provide blood and tissue specimens. 11 expected survival of> 6 months 12.karnofsky performance status (kps)> 60; eastern cooperative oncology group(ecog) score 0-2 13 signed informed consent form
Beschrijving

Availability of Blood specimen | Availability of Tissue specimen | Life Expectancy | Karnofsky Performance Status | ECOG performance status | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0178913
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1292533
UMLS CUI [3]
C0023671
UMLS CUI [4]
C0206065
UMLS CUI [5]
C1520224
UMLS CUI [6]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other cancers
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
2. cognitive inability and mental abnormalities
Beschrijving

Impaired cognition | Mental handicap

Datatype

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C1306341
3. other serious disease or condition
Beschrijving

Disease Serious | Condition Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0205404
severe, uncontrolled internal medicine and infectious diseases
Beschrijving

Internal medicine Disease Severe Uncontrolled | Communicable Disease Severe Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021782
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205082
UMLS CUI [1,4]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205318
severe digestive disorder can not control
Beschrijving

Digestive System Disorder Severe Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012242
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
severe electrolyte imbalance
Beschrijving

Electrolyte imbalance Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0342579
UMLS CUI [1,2]
C0205082
active disseminated intravascular coagulation
Beschrijving

Disseminated Intravascular Coagulation

Datatype

boolean

Alias
UMLS CUI [1]
C0012739
major organ failure, such as decompensated heart, lung, liver, kidney failure
Beschrijving

Organ Major Failure | Decompensated cardiac failure | Pulmonary failure Decompensated | Liver Failure Decompensated | Kidney Failure Decompensated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0178784
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C0231174
UMLS CUI [2]
C0581377
UMLS CUI [3,1]
C0948755
UMLS CUI [3,2]
C0205434
UMLS CUI [4,1]
C0085605
UMLS CUI [4,2]
C0205434
UMLS CUI [5,1]
C0035078
UMLS CUI [5,2]
C0205434
peripheral neuropathy symptoms, nci grade> ⅱ degree
Beschrijving

Peripheral Neuropathy Symptoms CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1516728
4. can not tolerate chemotherapy or refuse chemotherapy
Beschrijving

Intolerance Chemotherapy | Chemotherapy Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0392920
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1705116
5. using the other test drug or participate other clinical trials
Beschrijving

Investigational New Drugs | Study Subject Participation Status | Clinical Trial

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0008976
6. can not oral drugs
Beschrijving

Lacking Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0175795
7. receiving chemotherapy, biological therapy, or other anti-cancer medicine intervals less than 4 weeks
Beschrijving

Chemotherapy | Biological treatment | Cancer treatment | Treatment Interval

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0920425
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C1272706
8. researchers believe patients unsuitable (compliance, we should not follow-up)
Beschrijving

Study Subject Participation Status Inappropriate | Compliance behavior Lacking

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
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Similar models

Eligibility Hormone Refractory Prostate Cancer NCT02208583

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. 18 years and older;
boolean
C0001779 (UMLS CUI [1])
Prostatic Cancer, Castration-Resistant
Item
2. patients with crpc according to european association of urology diagnostic criteria ;
boolean
C3658266 (UMLS CUI [1])
Organ function | Bone Marrow function | Cardiac function | Liver function | Renal function
Item
3. vital organs functions including bone marrow, heart, liver, kidney are normal;
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232164 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
Specimen Complete Prostate carcinoma | Specimen Complete Hormone refractory prostate cancer | Biopsy | Surgical specimen | Biopsy Repeated Specimen | Transurethral Resection of Prostate Specimen | Neoplasm Metastasis Surgical specimen Palliative | Sample Deoxyribonucleic acid extraction | Quality Control Specimen | RNA Degradation Sample Absent | Absence DNA Sample | Amount Sample
Item
4. complete pathological specimens including newly diagnosed with prostate cancer and disease progress to crpc: ① biopsies or surgical specimens (tissue bank or wax block preserved specimens) at diagnosis ; ② re-biopsy specimens,transurethral prostatectomy (turp) specimens, metastases palliative surgical specimens (tissue bank or wax block preserved specimens) after progress to crpc; ③ amount sufficient sample for dna extraction and quality control by up to standard (a) sample type: none rna degradation and pollution-free dna samples; (b) the amount of the sample (single): ≥
boolean
C0370003 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
C0370003 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1328504 (UMLS CUI [2,3])
C0005558 (UMLS CUI [3])
C1647891 (UMLS CUI [4])
C0005558 (UMLS CUI [5,1])
C0205341 (UMLS CUI [5,2])
C0370003 (UMLS CUI [5,3])
C0040771 (UMLS CUI [6,1])
C0370003 (UMLS CUI [6,2])
C0027627 (UMLS CUI [7,1])
C1647891 (UMLS CUI [7,2])
C1285530 (UMLS CUI [7,3])
C0370003 (UMLS CUI [8,1])
C3839098 (UMLS CUI [8,2])
C1561524 (UMLS CUI [9])
C1257756 (UMLS CUI [10,1])
C0370003 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
C0332197 (UMLS CUI [11,1])
C0012854 (UMLS CUI [11,2])
C0370003 (UMLS CUI [11,3])
C1265611 (UMLS CUI [12,1])
C0370003 (UMLS CUI [12,2])
Sample Concentration measurement | Sample Purity
Item
250ng (using agilent liquid platform); (c) sample concentration: ≥ 50 ng / μl (using agilent liquid platform); (d) sample purity: od 260/280 = 1.8 ~ 2.0 );
boolean
C0370003 (UMLS CUI [1,1])
C1446561 (UMLS CUI [1,2])
C0370003 (UMLS CUI [2,1])
C1882508 (UMLS CUI [2,2])
Hematoxylin and eosin stain method | Immunohistochemistry | Sequencing of exon of gene
Item
5. then we perform following tests when patients meet the above criteria: ①histological analysis: hematoxylin-eosin(he) staining ②immunohistochemistry(ihc) staining ③ 48 carcinomas associated exon sequencing
boolean
C0523207 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C2733343 (UMLS CUI [3])
Treatment Group | docetaxel | Prednisone | PSA High | Gene Mutation Absent | Treatment Group | docetaxel | Prednisone | Drugs Targeted | PSA High | Gene Mutation | Treatment Group | Cisplatin | Etoposide | PSA low | Gene Mutation Absent
Item
6. after performing the above test, enter treatment group ① docetaxel & prednisone(dp) : with high psa and no gene mutation; ② dp + targeted drugs: with high psa and gene mutations; ③ cisplatin & etoposide(ep) : low psa and no gene mutation; ④ ep +
boolean
C0087111 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0246415 (UMLS CUI [2])
C0032952 (UMLS CUI [3])
C0138741 (UMLS CUI [4,1])
C0205250 (UMLS CUI [4,2])
C0596611 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0441833 (UMLS CUI [6,2])
C0246415 (UMLS CUI [7])
C0032952 (UMLS CUI [8])
C0013227 (UMLS CUI [9,1])
C1521840 (UMLS CUI [9,2])
C0138741 (UMLS CUI [10,1])
C0205250 (UMLS CUI [10,2])
C0596611 (UMLS CUI [11])
C0087111 (UMLS CUI [12,1])
C0441833 (UMLS CUI [12,2])
C0008838 (UMLS CUI [13])
C0015133 (UMLS CUI [14])
C0138741 (UMLS CUI [15,1])
C0205251 (UMLS CUI [15,2])
C0596611 (UMLS CUI [16,1])
C0332197 (UMLS CUI [16,2])
Treatment Group | Etoposide | Drugs Targeted | PSA low | Gene Mutation
Item
targeted drug: low psa and gene mutations.
boolean
C0087111 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0015133 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0138741 (UMLS CUI [4,1])
C0205251 (UMLS CUI [4,2])
C0596611 (UMLS CUI [5])
Peripheral blood Sample | Circulating Neoplastic Cells
Item
7. all patients enrolled in draw peripheral blood samples 7.5ml and detect circulating tumor cells (ctc) , monitoring efficacy.
boolean
C0229664 (UMLS CUI [1,1])
C0370003 (UMLS CUI [1,2])
C0027625 (UMLS CUI [2])
Protocol Compliance | Informed Consent
Item
8. willing and able to comply with the program during the study period. 9 before entering clinical trials to provide written informed consent form, and the patient has to know you can withdraw from the study at any time in the study, and without any loss.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Availability of Blood specimen | Availability of Tissue specimen | Life Expectancy | Karnofsky Performance Status | ECOG performance status | Informed Consent
Item
10. agrees to provide blood and tissue specimens. 11 expected survival of> 6 months 12.karnofsky performance status (kps)> 60; eastern cooperative oncology group(ecog) score 0-2 13 signed informed consent form
boolean
C0470187 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
C0206065 (UMLS CUI [4])
C1520224 (UMLS CUI [5])
C0021430 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
1. other cancers
boolean
C1707251 (UMLS CUI [1])
Impaired cognition | Mental handicap
Item
2. cognitive inability and mental abnormalities
boolean
C0338656 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
Disease Serious | Condition Serious
Item
3. other serious disease or condition
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Internal medicine Disease Severe Uncontrolled | Communicable Disease Severe Uncontrolled
Item
severe, uncontrolled internal medicine and infectious diseases
boolean
C0021782 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0205318 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
Digestive System Disorder Severe Uncontrolled
Item
severe digestive disorder can not control
boolean
C0012242 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Electrolyte imbalance Severe
Item
severe electrolyte imbalance
boolean
C0342579 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Disseminated Intravascular Coagulation
Item
active disseminated intravascular coagulation
boolean
C0012739 (UMLS CUI [1])
Organ Major Failure | Decompensated cardiac failure | Pulmonary failure Decompensated | Liver Failure Decompensated | Kidney Failure Decompensated
Item
major organ failure, such as decompensated heart, lung, liver, kidney failure
boolean
C0178784 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0231174 (UMLS CUI [1,3])
C0581377 (UMLS CUI [2])
C0948755 (UMLS CUI [3,1])
C0205434 (UMLS CUI [3,2])
C0085605 (UMLS CUI [4,1])
C0205434 (UMLS CUI [4,2])
C0035078 (UMLS CUI [5,1])
C0205434 (UMLS CUI [5,2])
Peripheral Neuropathy Symptoms CTCAE Grades
Item
peripheral neuropathy symptoms, nci grade> ⅱ degree
boolean
C0031117 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Intolerance Chemotherapy | Chemotherapy Refused
Item
4. can not tolerate chemotherapy or refuse chemotherapy
boolean
C0231199 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Investigational New Drugs | Study Subject Participation Status | Clinical Trial
Item
5. using the other test drug or participate other clinical trials
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
Lacking Able to swallow Oral medication
Item
6. can not oral drugs
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [1,3])
Chemotherapy | Biological treatment | Cancer treatment | Treatment Interval
Item
7. receiving chemotherapy, biological therapy, or other anti-cancer medicine intervals less than 4 weeks
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
C0087111 (UMLS CUI [4,1])
C1272706 (UMLS CUI [4,2])
Study Subject Participation Status Inappropriate | Compliance behavior Lacking
Item
8. researchers believe patients unsuitable (compliance, we should not follow-up)
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
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