ID

43786

Beschreibung

Carboplatin in Castration-resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02311764

Link

https://clinicaltrials.gov/show/NCT02311764

Stichworte

Versionen (2)
  1. 17.06.16 17.06.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostatic Neoplasm NCT02311764

Englisch

Eligibility Prostatic Neoplasm NCT02311764

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. written informed consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. adult patients with histological diagnosis of adenocarcinoma of the prostate.
Beschreibung

Adult | Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0007112
3. metastatic castration-resistant prostate cancer (mcrpc)
Beschreibung

Male Castration Resistant Metastatic Prostate Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007347
UMLS CUI [1,2]
C0332325
UMLS CUI [1,3]
C0936223
4. progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (cyp17 inhibitor or a new generation aa like enzalutamide).
Beschreibung

Chemotherapy taxane | Disease Progression | Medical contraindication taxane | Therapeutic procedure Hormone preparation | Cytochrome P450 17A1 Inhibitor | Amino Acids | enzalutamide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0215136
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0215136
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0019932
UMLS CUI [5]
C3160096
UMLS CUI [6]
C0002520
UMLS CUI [7]
C3496793
5. loss of pten by ihc (h-scores ≤ 30) and/or evidence of dna repair defects by ngs
Beschreibung

PTEN Loss | Immunohistochemistry | Score Histologic | Defect in DNA repair | Next Generation Sequencing

Datentyp

boolean

Alias
UMLS CUI [1]
C3272693
UMLS CUI [2]
C0021044
UMLS CUI [3,1]
C0449820
UMLS CUI [3,2]
C0205462
UMLS CUI [4]
C3278814
UMLS CUI [5]
C2936622
6. eastern cooperative oncology group (ecog) performance status (ps) 0 - 2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
7. progression of disease by any of the criteria listed here:
Beschreibung

Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
psa utilizing pcwg 2 criteria
Beschreibung

Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
bone scan
Beschreibung

Radioisotope scan of bone

Datentyp

boolean

Alias
UMLS CUI [1]
C0203668
recist 1.1
Beschreibung

RECIST

Datentyp

boolean

Alias
UMLS CUI [1]
C1709926
8. adequate organ and bone marrow function as evidenced by:
Beschreibung

organ function | Bone Marrow physiological aspects

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
haemoglobin ≥8.0 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count ≥1.5 x 109/l
Beschreibung

Absolute neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100 x 109/l
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
ast and/or alt < 2.5 x uln, in the presence of liver metastases: ast ≥5 x uln, alt <5 x uln
Beschreibung

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datentyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
total bilirubin < 2.0 x uln (except for patients with gilbert's disease)
Beschreibung

Bilirubin, total measurement | Gilbert Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0017551
creatinine clearance ≥30ml/min
Beschreibung

Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0373595
9. patient must agree in the biomarker studies including the fresh tumour biopsies
Beschreibung

Agree Biological Markers Clinical study | Malignant Neoplasm Biopsy Fresh Specimen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3641827
UMLS CUI [1,2]
C0005516
UMLS CUI [1,3]
C0008972
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C2827486
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product carboplatin
Beschreibung

Medical contraindication Class of Trial Agent | Hypersensitivity Class of Trial Agent | Hypersensitivity Carboplatin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2983595
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2983595
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0079083
2. prior treatment with any prior platinum based chemotherapy,
Beschreibung

Prior Therapy | Prior Chemotherapy Platinum-Based

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
3. major surgery within 4 weeks prior to planned start of treatment
Beschreibung

major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
4. known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
Beschreibung

Brain Involvement with | Leptomeninges Involvement with | Stable status Clinical | Steroids Dosage Stable status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C1314939
UMLS CUI [2,1]
C0228126
UMLS CUI [2,2]
C1314939
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0205210
UMLS CUI [4,1]
C0038317
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
5. inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Beschreibung

Study Protocol Compliance behavior Unable | problem; language | Mental disorders | Dementia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C1405458
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0497327
6. previous enrolment into the current study
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
7. active secondary malignancy that requires systemic therapy.
Beschreibung

Secondary Malignant Neoplasm Requirement systemic therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3266877
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
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Ähnliche Modelle

Eligibility Prostatic Neoplasm NCT02311764

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. written informed consent
boolean
C0021430 (UMLS CUI [1])
Adult | Adenocarcinoma of prostate
Item
2. adult patients with histological diagnosis of adenocarcinoma of the prostate.
boolean
C0001675 (UMLS CUI [1])
C0007112 (UMLS CUI [2])
Male Castration Resistant Metastatic Prostate Carcinoma
Item
3. metastatic castration-resistant prostate cancer (mcrpc)
boolean
C0007347 (UMLS CUI [1,1])
C0332325 (UMLS CUI [1,2])
C0936223 (UMLS CUI [1,3])
Chemotherapy taxane | Disease Progression | Medical contraindication taxane | Therapeutic procedure Hormone preparation | Cytochrome P450 17A1 Inhibitor | Amino Acids | enzalutamide
Item
4. progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (cyp17 inhibitor or a new generation aa like enzalutamide).
boolean
C0392920 (UMLS CUI [1,1])
C0215136 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0019932 (UMLS CUI [4,2])
C3160096 (UMLS CUI [5])
C0002520 (UMLS CUI [6])
C3496793 (UMLS CUI [7])
PTEN Loss | Immunohistochemistry | Score Histologic | Defect in DNA repair | Next Generation Sequencing
Item
5. loss of pten by ihc (h-scores ≤ 30) and/or evidence of dna repair defects by ngs
boolean
C3272693 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0449820 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
C3278814 (UMLS CUI [4])
C2936622 (UMLS CUI [5])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) performance status (ps) 0 - 2
boolean
C1520224 (UMLS CUI [1])
Disease Progression
Item
7. progression of disease by any of the criteria listed here:
boolean
C0242656 (UMLS CUI [1])
Prostate specific antigen measurement
Item
psa utilizing pcwg 2 criteria
boolean
C0201544 (UMLS CUI [1])
Radioisotope scan of bone
Item
bone scan
boolean
C0203668 (UMLS CUI [1])
RECIST
Item
recist 1.1
boolean
C1709926 (UMLS CUI [1])
organ function | Bone Marrow physiological aspects
Item
8. adequate organ and bone marrow function as evidenced by:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Hemoglobin measurement
Item
haemoglobin ≥8.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count ≥1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
ast and/or alt < 2.5 x uln, in the presence of liver metastases: ast ≥5 x uln, alt <5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Bilirubin, total measurement | Gilbert Disease
Item
total bilirubin < 2.0 x uln (except for patients with gilbert's disease)
boolean
C0201913 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance ≥30ml/min
boolean
C0373595 (UMLS CUI [1])
Agree Biological Markers Clinical study | Malignant Neoplasm Biopsy Fresh Specimen
Item
9. patient must agree in the biomarker studies including the fresh tumour biopsies
boolean
C3641827 (UMLS CUI [1,1])
C0005516 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C2827486 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Class of Trial Agent | Hypersensitivity Class of Trial Agent | Hypersensitivity Carboplatin
Item
1. contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product carboplatin
boolean
C1301624 (UMLS CUI [1,1])
C2983595 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2983595 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
Prior Therapy | Prior Chemotherapy Platinum-Based
Item
2. prior treatment with any prior platinum based chemotherapy,
boolean
C1514463 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
major surgery
Item
3. major surgery within 4 weeks prior to planned start of treatment
boolean
C0679637 (UMLS CUI [1])
Brain Involvement with | Leptomeninges Involvement with | Stable status Clinical | Steroids Dosage Stable status
Item
4. known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
boolean
C0006104 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0228126 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0205360 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Study Protocol Compliance behavior Unable | problem; language | Mental disorders | Dementia
Item
5. inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
boolean
C2348563 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1405458 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
Study Subject Participation Status
Item
6. previous enrolment into the current study
boolean
C2348568 (UMLS CUI [1])
Secondary Malignant Neoplasm Requirement systemic therapy
Item
7. active secondary malignancy that requires systemic therapy.
boolean
C3266877 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
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