ID

15862

Descripción

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

Link

https://clinicaltrials.gov/show/NCT02362464

Palabras clave

Versiones (1)
  1. 16/6/16 16/6/16 -
Subido en

16 de junio de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Prostatic Neoplams NCT02362464

Inglés

Eligibility Prostatic Neoplams NCT02362464

1 formularios  
Criteria
Descripción

Criteria

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

Gender | Age | Adenocarcinoma of prostate

Tipo de datos

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).
Descripción

Study Subject Participation Status | TARP Peptide Vaccine

Tipo de datos

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.
Descripción

ECOG performance status | Life Expectancy

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Prothrombin time | Partial Thromboplastin Time measurement | Anticoagulant therapy

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Hepatitis B test negative | Hepatitis C test negative

Tipo de datos

boolean

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

HIV negative

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Chemotherapy | Therapeutic radiology procedure

Tipo de datos

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.
Descripción

Prostate carcinoma | Standard of Care | Antiandrogen therapy

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

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

Compliance behavior Study Protocol

Tipo de datos

boolean

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

Timeline

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705821
Exclusion Criteria
Descripción

Exclusion Criteria

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

Neoplasms, Second Primary Requirement Therapeutic procedure

Tipo de datos

boolean

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

Communicable Diseases

Tipo de datos

boolean

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

Therapeutic immunosuppression

Tipo de datos

boolean

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

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

Tipo de datos

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.
Descripción

Illness Significant | Illness Uncontrolled | Mild asthma

Tipo de datos

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:
Descripción

Problem Medical | Psychosocial problem

Tipo de datos

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
Descripción

medical condition Serious

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Volver a la parte superior de la página

Similar models

Eligibility Prostatic Neoplams NCT02362464

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial