ID

40826

Beskrivning

Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01422850

Länk

https://clinicaltrials.gov/show/NCT01422850

Nyckelord

Versioner (1)
  1. 2020-05-20 2020-05-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 maj 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hormone-refractory Prostate Cancer NCT01422850

Engelsk

Eligibility Hormone-refractory Prostate Cancer NCT01422850

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
Beskrivning

Castration Levels of Testosterone | Total Testosterone Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C4289828
UMLS CUI [2]
C0202227
2. three consecutive rises of psa minimum 1 week apart, resulting in at least two 50 % increases over the psa nadir.
Beskrivning

Raised PSA Occurrence Quantity | PSA Percent Change From Nadir

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178415
UMLS CUI [1,2]
C2745955
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0138741
UMLS CUI [2,2]
C3272908
3. antiandrogen withdrawal for at least 4 weeks, or psa progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
Beskrivning

Androgen Antagonists Withdrawal | Raised PSA | Hormone manipulation Secondary | Bone lesion Progression | Soft tissue lesion Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002842
UMLS CUI [1,2]
C2349954
UMLS CUI [2]
C0178415
UMLS CUI [3,1]
C0586971
UMLS CUI [3,2]
C0175668
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0449258
UMLS CUI [5,1]
C0410013
UMLS CUI [5,2]
C0449258
4. be over the age of 18 and capable of understanding the information and giving informed consent.
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
5. expected survival time (life expectancy) of over 6 months.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
6. adequate performance status better than 2 (who/ecog performance status score).
Beskrivning

WHO performance status scale | ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
UMLS CUI [2]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. a low blood count (haemoglobin < 6.0 mmol/l).
Beskrivning

Blood Count low | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005771
UMLS CUI [1,2]
C0205251
UMLS CUI [2]
C0518015
2. lymphocyte counts below 0.8 x 109/l.
Beskrivning

Lymphocyte Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0200635
3. positive tests for anti-hiv-1/2; hbsag, anti-hbc (hepatitis b core antigen) and anti-hcv (hepatitis c virus).
Beskrivning

HIV-1 antibody Positive | HIV-2 antibody Positive | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis C antibody positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0369497
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0369500
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0262506
UMLS CUI [5]
C0281863
4. syphilis i.e. being positive in a treponema pallidum test.
Beskrivning

Syphilis | Treponema pallidum test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0039128
UMLS CUI [2]
C2748144
5. uncontrolled serious bacterial, viral, fungal or parasitic infection.
Beskrivning

Bacterial Infection Serious Uncontrolled | Virus Disease Serious Uncontrolled | Mycoses Serious Uncontrolled | Parasitic infection Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0042769
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3,1]
C0026946
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C0205318
UMLS CUI [4,1]
C0747256
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0205318
6. clinically significant autoimmune disorders or conditions of immune suppression.
Beskrivning

Autoimmune Diseases | Immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C4048329
7. treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
Beskrivning

Steroid therapy | Bisphosphonate therapy | Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2]
C4510264
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
8. blood transfusions within 48 hours prior to donation of blood for alecsat production.
Beskrivning

Blood Transfusion | Status pre- Blood Donation ALECSAT

Datatyp

boolean

Alias
UMLS CUI [1]
C0005841
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0005794
UMLS CUI [2,3]
C3827167
9. inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the alecsat clinical trial.
Beskrivning

Study Subject Participation Status | Clinical Trial

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
10. any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of side effects difficult.
Beskrivning

Medical condition Study Subject Participation Status At risk | Medical condition Assessment Side effects Difficult

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0879626
UMLS CUI [2,4]
C0332218
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Similar models

Eligibility Hormone-refractory Prostate Cancer NCT01422850

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Castration Levels of Testosterone | Total Testosterone Measurement
Item
1. serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
boolean
C4289828 (UMLS CUI [1])
C0202227 (UMLS CUI [2])
Raised PSA Occurrence Quantity | PSA Percent Change From Nadir
Item
2. three consecutive rises of psa minimum 1 week apart, resulting in at least two 50 % increases over the psa nadir.
boolean
C0178415 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0138741 (UMLS CUI [2,1])
C3272908 (UMLS CUI [2,2])
Androgen Antagonists Withdrawal | Raised PSA | Hormone manipulation Secondary | Bone lesion Progression | Soft tissue lesion Progression
Item
3. antiandrogen withdrawal for at least 4 weeks, or psa progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
boolean
C0002842 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
C0586971 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0449258 (UMLS CUI [4,2])
C0410013 (UMLS CUI [5,1])
C0449258 (UMLS CUI [5,2])
Age | Informed Consent
Item
4. be over the age of 18 and capable of understanding the information and giving informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Life Expectancy
Item
5. expected survival time (life expectancy) of over 6 months.
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale | ECOG performance status
Item
6. adequate performance status better than 2 (who/ecog performance status score).
boolean
C1298650 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Blood Count low | Hemoglobin measurement
Item
1. a low blood count (haemoglobin < 6.0 mmol/l).
boolean
C0005771 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
Lymphocyte Count measurement
Item
2. lymphocyte counts below 0.8 x 109/l.
boolean
C0200635 (UMLS CUI [1])
HIV-1 antibody Positive | HIV-2 antibody Positive | Hepatitis B surface antigen positive | Hepatitis B core antibody positive | Hepatitis C antibody positive
Item
3. positive tests for anti-hiv-1/2; hbsag, anti-hbc (hepatitis b core antigen) and anti-hcv (hepatitis c virus).
boolean
C0369497 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0369500 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
C0262506 (UMLS CUI [4])
C0281863 (UMLS CUI [5])
Syphilis | Treponema pallidum test positive
Item
4. syphilis i.e. being positive in a treponema pallidum test.
boolean
C0039128 (UMLS CUI [1])
C2748144 (UMLS CUI [2])
Bacterial Infection Serious Uncontrolled | Virus Disease Serious Uncontrolled | Mycoses Serious Uncontrolled | Parasitic infection Serious Uncontrolled
Item
5. uncontrolled serious bacterial, viral, fungal or parasitic infection.
boolean
C0004623 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0042769 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0026946 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0747256 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
Autoimmune Diseases | Immunosuppression
Item
6. clinically significant autoimmune disorders or conditions of immune suppression.
boolean
C0004364 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
Steroid therapy | Bisphosphonate therapy | Chemotherapy | Therapeutic radiology procedure
Item
7. treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in chemotherapy or radiation treatment one month prior to inclusion in the clinical trial.
boolean
C0149783 (UMLS CUI [1])
C4510264 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
Blood Transfusion | Status pre- Blood Donation ALECSAT
Item
8. blood transfusions within 48 hours prior to donation of blood for alecsat production.
boolean
C0005841 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0005794 (UMLS CUI [2,2])
C3827167 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial
Item
9. inclusion in other clinical trials 6 weeks prior to inclusion in the trial or enrolment in other clinical trials during the alecsat clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Medical condition Study Subject Participation Status At risk | Medical condition Assessment Side effects Difficult
Item
10. any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of side effects difficult.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0879626 (UMLS CUI [2,3])
C0332218 (UMLS CUI [2,4])
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