ID

39884

Descrição

A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas; ODM derived from: https://clinicaltrials.gov/show/NCT01985958

Link

https://clinicaltrials.gov/show/NCT01985958

Palavras-chave

Versões (1)
  1. 27/02/2020 27/02/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

27 de fevereiro de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

Inglês

Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological diagnosis of pancreatic carcinoma
Descrição

Pancreatic carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235974
patients ≥ 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status 0,1,or 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
patients must have distant metastatic disease (stage 4)
Descrição

Distant metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269798
satisfactory organ and bone marrow function as defined by: absolute neutrophil count> 1,000/ul, platelets > 75,000ul hemoglobin > 9 bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
Descrição

Organ function | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Exception Secondary to Cholestasis | Cholestasis Due to Tumor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
UMLS CUI [6]
C1278039
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0175668
UMLS CUI [7,3]
C0008370
UMLS CUI [8,1]
C0008370
UMLS CUI [8,2]
C0678226
UMLS CUI [8,3]
C0027651
creatinine ≤ 1.5x the institutional normal upper limit
Descrição

Creatinine measurement, serum

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 5x the institutional normal upper limit.
Descrição

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
a clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
Descrição

Recommendation Therapeutic radiology procedure Primary Lesion | Recommendation Therapeutic radiology procedure Metastatic Lesion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0034866
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1402294
UMLS CUI [2,1]
C0034866
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C1513183
must be able to provide informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior radiation to the area planned for radiotherapy
Descrição

Prior radiation therapy Area Planned Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C1522449
active invasive cancer other than pancreatic adenocarcinoma. non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with psa level < 1.0 are not excluded.
Descrição

Invasive cancer | Exception Adenocarcinoma of pancreas | Exception Skin carcinoma | Exception Superficial cervix carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma PSA Level

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0281361
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0302592
UMLS CUI [4,3]
C0205124
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1336527
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0600139
UMLS CUI [6,3]
C4086720
known hiv, hcv and/or hbv positive (by patient report/medical record)
Descrição

HIV Seropositivity | Hepatitis C Virus Positive | Hepatitis B Virus Positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C4330254
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C1514241
patients with ongoing or active infection
Descrição

Communicable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
planned concurrent treatment with systemic high dose corticosteroids.
Descrição

CORTICOSTEROIDS FOR SYSTEMIC USE High dose Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C1301732
received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
Descrição

Cancer treatment | Systemic therapy | Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C1515119
UMLS CUI [3]
C1522449
immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
Descrição

Immunotherapy | Monoclonal Antibodies

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0003250
immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
Descrição

Therapeutic immunosuppression | Steroid therapy | Cyclosporine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0010592
Voltar ao início da página

Similar models

Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Pancreatic carcinoma
Item
histological or cytological diagnosis of pancreatic carcinoma
boolean
C0235974 (UMLS CUI [1])
Age
Item
patients ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0,1,or 2
boolean
C1520224 (UMLS CUI [1])
Distant metastasis
Item
patients must have distant metastatic disease (stage 4)
boolean
C1269798 (UMLS CUI [1])
Organ function | Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Exception Secondary to Cholestasis | Cholestasis Due to Tumor
Item
satisfactory organ and bone marrow function as defined by: absolute neutrophil count> 1,000/ul, platelets > 75,000ul hemoglobin > 9 bilirubin ≤ 2.0x the institutional normal upper limit unless secondary to bile duct obstruction by tumor,
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0175668 (UMLS CUI [7,2])
C0008370 (UMLS CUI [7,3])
C0008370 (UMLS CUI [8,1])
C0678226 (UMLS CUI [8,2])
C0027651 (UMLS CUI [8,3])
Creatinine measurement, serum
Item
creatinine ≤ 1.5x the institutional normal upper limit
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 5x the institutional normal upper limit.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Recommendation Therapeutic radiology procedure Primary Lesion | Recommendation Therapeutic radiology procedure Metastatic Lesion
Item
a clinical recommendation for radiotherapy to the primary or a metastatic lesion had been made.
boolean
C0034866 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1402294 (UMLS CUI [1,3])
C0034866 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1513183 (UMLS CUI [2,3])
Informed Consent
Item
must be able to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy Area Planned Therapeutic radiology procedure
Item
no prior radiation to the area planned for radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Invasive cancer | Exception Adenocarcinoma of pancreas | Exception Skin carcinoma | Exception Superficial cervix carcinoma | Exception Superficial carcinoma of urinary bladder | Exception Prostate carcinoma PSA Level
Item
active invasive cancer other than pancreatic adenocarcinoma. non-melanoma skin cancer, superficial cervical or bladder cancer and prostate cancer with psa level < 1.0 are not excluded.
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0281361 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0302592 (UMLS CUI [4,2])
C0205124 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0600139 (UMLS CUI [6,2])
C4086720 (UMLS CUI [6,3])
HIV Seropositivity | Hepatitis C Virus Positive | Hepatitis B Virus Positive
Item
known hiv, hcv and/or hbv positive (by patient report/medical record)
boolean
C0019699 (UMLS CUI [1])
C4330254 (UMLS CUI [2])
C0019169 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Communicable Disease
Item
patients with ongoing or active infection
boolean
C0009450 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE High dose Planned
Item
planned concurrent treatment with systemic high dose corticosteroids.
boolean
C3653708 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Cancer treatment | Systemic therapy | Therapeutic radiology procedure
Item
received an anticancer treatment (systemic therapy or radiation therapy)within 21 days prior to enrollment.
boolean
C0920425 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Immunotherapy | Monoclonal Antibodies
Item
immunotherapy (e.g. monoclonal antibodies)within 21 days prior to enrollment.
boolean
C0021083 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
Therapeutic immunosuppression | Steroid therapy | Cyclosporine
Item
immunosuppressive therapies (e.g. steroids, cyclosporine) are not permitted.
boolean
C0021079 (UMLS CUI [1])
C0149783 (UMLS CUI [2])
C0010592 (UMLS CUI [3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

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