ID

15862

Beskrivning

Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139; ODM derived from: https://clinicaltrials.gov/show/NCT02362464

Länk

https://clinicaltrials.gov/show/NCT02362464

Nyckelord

Versioner (1)
  1. 2016-06-16 2016-06-16 -
Uppladdad den

16 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostatic Neoplams NCT02362464

Engelsk

Eligibility Prostatic Neoplams NCT02362464

1 Formulär  
Criteria
Beskrivning

Criteria

males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
Beskrivning

Gender | Age | Adenocarcinoma of prostate

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0007112
prior enrollment in nci protocol 09-c-0139 with receipt of at least 5 doses of tarp peptide vaccine (i.e. completion of primary vaccination series).
Beskrivning

Study Subject Participation Status | TARP Peptide Vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0960676
UMLS CUI [2,2]
C0599934
performance status: ecog 0-1, life expectancy of greater than or equal to 1 year.
Beskrivning

ECOG performance status | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
hemoglobin greater than or equal to 10.0 gm/dl, wbc greater than or equal to 2,500/mm3, alc greater than or equal to 500/mm3, anc greater than or equal to 1,000/mm3, platelet count greater than or equal to 100,000/mm3.
Beskrivning

Hemoglobin | White Blood Cell Count procedure | Absolute lymphocyte count | Absolute neutrophil count | Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0023508
UMLS CUI [3]
C3544087
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
pt/ptt less than or equal to 1.5x uln unless receiving clinically indicated anticoagulant therapy.
Beskrivning

Prothrombin time | Partial Thromboplastin Time measurement | Anticoagulant therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0030605
UMLS CUI [3]
C0150457
sgot/sgpt less than or equal to 2.5x uln, total bilirubin less than or equal to 1.5x uln, cr less than or equal to 1.5x uln, estimated gfr (egfr) greater than or equal to 60 ml/min.
Beskrivning

Aspartate Transaminase | Alanine Transaminase | Bilirubin, total measurement | Creatinine measurement | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1]
C0004002
UMLS CUI [2]
C0001899
UMLS CUI [3]
C0201913
UMLS CUI [4]
C0201975
UMLS CUI [5]
C3811844
hepatitis b and c negative, unless the result is consistent with prior vaccination or prior infection with full recovery.
Beskrivning

Hepatitis B test negative | Hepatitis C test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C1619717
hiv negative
Beskrivning

HIV negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0481430
no use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including ivig) within 8 weeks of study entry. note: use of topical, inhaled and intranasal steroid therapy is permitted.
Beskrivning

Investigational New Drugs Not used | Immunosuppressive Agents | Biological Response Modifiers | Immunoglobulins, Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0445107
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0005525
UMLS CUI [4]
C0085297
greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy.
Beskrivning

Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1522449
standard of care medical management of current prostate cancer disease status by the patient s local oncologist, e.g. androgen deprivation therapy is allowed.
Beskrivning

Prostate carcinoma | Standard of Care | Antiandrogen therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0600139
UMLS CUI [2]
C2936643
UMLS CUI [3]
C0279492
able to understand and provide informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
must be able and willing to adhere to protocol requirements, visits and vaccination
Beskrivning

Compliance behavior Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C2348563
timeline.
Beskrivning

Timeline

Datatyp

boolean

Alias
UMLS CUI [1]
C1705821
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a second malignancy requiring active treatment.
Beskrivning

Neoplasms, Second Primary Requirement Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085183
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
patients with an active infection.
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
patients on immunosuppressive therapy including:
Beskrivning

Therapeutic immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1]
C0021079
-systemic corticosteroid therapy for any reason. patients receiving inhaled, intranasal or topical corticosteroids may participate.
Beskrivning

Steroid therapy Systemic | inhaled steroids | Adrenal Cortex Hormones Intranasal | Topical corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C2065041
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0001560
UMLS CUI [4]
C0304604
other significant or uncontrolled medical illness. patients with a remote history of or active mild asthma may participate.
Beskrivning

Illness Significant | Illness Uncontrolled | Mild asthma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0581124
patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:
Beskrivning

Problem Medical | Psychosocial problem

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033213
UMLS CUI [1,2]
C0205476
UMLS CUI [2]
C0740697
other serious non-malignancy-associated medical conditions that may be
Beskrivning

medical condition Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0205404
expected to limit life expectancy to less than 2 years.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Prostatic Neoplams NCT02362464

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Gender | Age | Adenocarcinoma of prostate
Item
males greater than or equal to 18 years of age with histologically confirmed adenocarcinoma of the prostate.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0007112 (UMLS CUI [3])
Study Subject Participation Status | TARP Peptide Vaccine
Item
prior enrollment in nci protocol 09-c-0139 with receipt of at least 5 doses of tarp peptide vaccine (i.e. completion of primary vaccination series).
boolean
C2348568 (UMLS CUI [1])
C0960676 (UMLS CUI [2,1])
C0599934 (UMLS CUI [2,2])
ECOG performance status | Life Expectancy
Item
performance status: ecog 0-1, life expectancy of greater than or equal to 1 year.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Hemoglobin | White Blood Cell Count procedure | Absolute lymphocyte count | Absolute neutrophil count | Platelet Count measurement
Item
hemoglobin greater than or equal to 10.0 gm/dl, wbc greater than or equal to 2,500/mm3, alc greater than or equal to 500/mm3, anc greater than or equal to 1,000/mm3, platelet count greater than or equal to 100,000/mm3.
boolean
C0019046 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C3544087 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Prothrombin time | Partial Thromboplastin Time measurement | Anticoagulant therapy
Item
pt/ptt less than or equal to 1.5x uln unless receiving clinically indicated anticoagulant therapy.
boolean
C0033707 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
C0150457 (UMLS CUI [3])
Aspartate Transaminase | Alanine Transaminase | Bilirubin, total measurement | Creatinine measurement | Estimated Glomerular Filtration Rate
Item
sgot/sgpt less than or equal to 2.5x uln, total bilirubin less than or equal to 1.5x uln, cr less than or equal to 1.5x uln, estimated gfr (egfr) greater than or equal to 60 ml/min.
boolean
C0004002 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
C0201913 (UMLS CUI [3])
C0201975 (UMLS CUI [4])
C3811844 (UMLS CUI [5])
Hepatitis B test negative | Hepatitis C test negative
Item
hepatitis b and c negative, unless the result is consistent with prior vaccination or prior infection with full recovery.
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
HIV negative
Item
hiv negative
boolean
C0481430 (UMLS CUI [1])
Investigational New Drugs Not used | Immunosuppressive Agents | Biological Response Modifiers | Immunoglobulins, Intravenous
Item
no use of investigational agents within 4 weeks of study enrollment or use of immunosuppressive or immunomodulating agents (including ivig) within 8 weeks of study entry. note: use of topical, inhaled and intranasal steroid therapy is permitted.
boolean
C0013230 (UMLS CUI [1,1])
C0445107 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
C0005525 (UMLS CUI [3])
C0085297 (UMLS CUI [4])
Chemotherapy | Therapeutic radiology procedure
Item
greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy.
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Prostate carcinoma | Standard of Care | Antiandrogen therapy
Item
standard of care medical management of current prostate cancer disease status by the patient s local oncologist, e.g. androgen deprivation therapy is allowed.
boolean
C0600139 (UMLS CUI [1])
C2936643 (UMLS CUI [2])
C0279492 (UMLS CUI [3])
Informed Consent
Item
able to understand and provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Study Protocol
Item
must be able and willing to adhere to protocol requirements, visits and vaccination
boolean
C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Timeline
Item
timeline.
boolean
C1705821 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasms, Second Primary Requirement Therapeutic procedure
Item
patients with a second malignancy requiring active treatment.
boolean
C0085183 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Communicable Diseases
Item
patients with an active infection.
boolean
C0009450 (UMLS CUI [1])
Therapeutic immunosuppression
Item
patients on immunosuppressive therapy including:
boolean
C0021079 (UMLS CUI [1])
Steroid therapy Systemic | inhaled steroids | Adrenal Cortex Hormones Intranasal | Topical corticosteroids
Item
-systemic corticosteroid therapy for any reason. patients receiving inhaled, intranasal or topical corticosteroids may participate.
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C0001560 (UMLS CUI [3,2])
C0304604 (UMLS CUI [4])
Illness Significant | Illness Uncontrolled | Mild asthma
Item
other significant or uncontrolled medical illness. patients with a remote history of or active mild asthma may participate.
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0581124 (UMLS CUI [3])
Problem Medical | Psychosocial problem
Item
patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:
boolean
C0033213 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0740697 (UMLS CUI [2])
medical condition Serious
Item
other serious non-malignancy-associated medical conditions that may be
boolean
C1699700 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Life Expectancy
Item
expected to limit life expectancy to less than 2 years.
boolean
C0023671 (UMLS CUI [1])
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