ID

19021

Beskrivning

Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00292045

Länk

https://clinicaltrials.gov/show/NCT00292045

Nyckelord

Versioner (1)
  1. 2016-11-30 2016-11-30 -
Uppladdad den

30 november 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00004011 NCT00292045

Engelsk

Eligibility Prostate Cancer NCT00292045

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have high-risk stage d1 or metastatic prostate cancer (d2), confirmed by review of histology.
Beskrivning

Prostate carcinoma Whitmore-Jewett staging system | Secondary malignant neoplasm of prostate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C1520141
UMLS CUI [2]
C0347001
2. patients must have fully recovered from surgery.
Beskrivning

Operative Surgical Procedure Patients Recovered

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0521108
3. patients must show stable or progressive disease as assessed by x-ray, ultrasound, and/or ct scans under hormonal and/or chemotherapeutic treatment, that had been administered for at least three months.
Beskrivning

Stable Disease | Progressive Disease | Radiography | Ultrasonography | X-Ray Computed Tomography | Hormone Therapy | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2]
C1335499
UMLS CUI [3]
C0034571
UMLS CUI [4]
C0041618
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0279025
UMLS CUI [7]
C0392920
4. any pretreatment with chemo- or radiotherapy must have been discontinued for at least four weeks prior to first dose of study agent. hormone therapy is allowed before and throughout the study.
Beskrivning

Chemotherapy Pretreatment Discontinued | Therapeutic radiology procedure Pretreatment Discontinued | Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C3539075
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C3539075
UMLS CUI [2,3]
C1444662
UMLS CUI [3]
C0279025
5. patients must have an expected survival of at least three months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. patients must have a karnofsky performance status of 70% or more.
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
7. within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
Beskrivning

Laboratory Results Normal Range

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0086715
leukocytes >3.000/ul
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
lymphocytes >700/ul
Beskrivning

Lymphocyte Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200635
platelets >100.000/ul
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine <2.5 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
alt, ast, and total bilirubin all < 2.5 x uln
Beskrivning

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C1278039
8. age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
9. able to give valid written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinically significant heart disease (nyha class iii or iv).
Beskrivning

Heart Disease Clinical Significance New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1275491
2. other serious illnesses, eg, active infections requiring antibiotics, bleeding disorders.
Beskrivning

Illness Serious | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [3]
C0005779
3. concomitant systemic treatment with corticosteroids. topical or inhalational steroids are permitted.
Beskrivning

systemic steroids | topical steroids | Steroids Inhalation

Datatyp

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C2064827
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0205535
4. metastatic disease to the central nervous system.
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
5. mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
Beskrivning

Mental impairment Limiting Informed Consent | Mental impairment Limiting Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0683322
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
6. lack of availability for immunological and clinical follow-up assessments.
Beskrivning

Follow-up immunological Availability Lack | Follow-up Clinical Availability Lack

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C0205470
UMLS CUI [1,3]
C0470187
UMLS CUI [1,4]
C0332268
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C0470187
UMLS CUI [2,4]
C0332268
7. participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
Beskrivning

Study Subject Participation Status | Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0013230
8. being a recipient of an organ or bone marrow allograft. having an autoimmune disease other than vitiligo, such as, but not limited to, inflammatory bowel disease or multiple sclerosis.
Beskrivning

Recipient organ | Recipient Bone Marrow Allograft | Autoimmune Diseases | Vitiligo | Inflammatory Bowel Diseases | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1709854
UMLS CUI [1,2]
C0524930
UMLS CUI [2,1]
C1709854
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0450127
UMLS CUI [3]
C0004364
UMLS CUI [4]
C0042900
UMLS CUI [5]
C0021390
UMLS CUI [6]
C0026769
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Similar models

Eligibility Prostate Cancer NCT00292045

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma Whitmore-Jewett staging system | Secondary malignant neoplasm of prostate
Item
1. patients must have high-risk stage d1 or metastatic prostate cancer (d2), confirmed by review of histology.
boolean
C0600139 (UMLS CUI [1,1])
C1520141 (UMLS CUI [1,2])
C0347001 (UMLS CUI [2])
Operative Surgical Procedure Patients Recovered
Item
2. patients must have fully recovered from surgery.
boolean
C0543467 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0521108 (UMLS CUI [1,3])
Stable Disease | Progressive Disease | Radiography | Ultrasonography | X-Ray Computed Tomography | Hormone Therapy | Chemotherapy
Item
3. patients must show stable or progressive disease as assessed by x-ray, ultrasound, and/or ct scans under hormonal and/or chemotherapeutic treatment, that had been administered for at least three months.
boolean
C0677946 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0034571 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
Chemotherapy Pretreatment Discontinued | Therapeutic radiology procedure Pretreatment Discontinued | Hormone Therapy
Item
4. any pretreatment with chemo- or radiotherapy must have been discontinued for at least four weeks prior to first dose of study agent. hormone therapy is allowed before and throughout the study.
boolean
C0392920 (UMLS CUI [1,1])
C3539075 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C3539075 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0279025 (UMLS CUI [3])
Life Expectancy
Item
5. patients must have an expected survival of at least three months.
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status
Item
6. patients must have a karnofsky performance status of 70% or more.
boolean
C0206065 (UMLS CUI [1])
Laboratory Results Normal Range
Item
7. within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
leukocytes >3.000/ul
boolean
C0023508 (UMLS CUI [1])
Lymphocyte Count measurement
Item
lymphocytes >700/ul
boolean
C0200635 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >100.000/ul
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
alt, ast, and total bilirubin all < 2.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Age
Item
8. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
9. able to give valid written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Heart Disease Clinical Significance New York Heart Association Classification
Item
1. clinically significant heart disease (nyha class iii or iv).
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Illness Serious | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders
Item
2. other serious illnesses, eg, active infections requiring antibiotics, bleeding disorders.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C0005779 (UMLS CUI [3])
systemic steroids | topical steroids | Steroids Inhalation
Item
3. concomitant systemic treatment with corticosteroids. topical or inhalational steroids are permitted.
boolean
C2825233 (UMLS CUI [1])
C2064827 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
CNS metastases
Item
4. metastatic disease to the central nervous system.
boolean
C0686377 (UMLS CUI [1])
Mental impairment Limiting Informed Consent | Mental impairment Limiting Protocol Compliance
Item
5. mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
boolean
C0683322 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0683322 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Follow-up immunological Availability Lack | Follow-up Clinical Availability Lack
Item
6. lack of availability for immunological and clinical follow-up assessments.
boolean
C3274571 (UMLS CUI [1,1])
C0205470 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C3274571 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Study Subject Participation Status | Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
7. participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
boolean
C2348568 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Recipient organ | Recipient Bone Marrow Allograft | Autoimmune Diseases | Vitiligo | Inflammatory Bowel Diseases | Multiple Sclerosis
Item
8. being a recipient of an organ or bone marrow allograft. having an autoimmune disease other than vitiligo, such as, but not limited to, inflammatory bowel disease or multiple sclerosis.
boolean
C1709854 (UMLS CUI [1,1])
C0524930 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0450127 (UMLS CUI [2,3])
C0004364 (UMLS CUI [3])
C0042900 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0026769 (UMLS CUI [6])
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