ID

39884

Beschreibung

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

Stichworte

Versionen (1)
  1. 27.02.20 27.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

Englisch

Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Pancreatic carcinoma

Datentyp

boolean

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

Age

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Distant metastasis

Datentyp

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,
Beschreibung

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

Datentyp

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
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

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

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Prior radiation therapy Area Planned Therapeutic radiology procedure

Datentyp

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.
Beschreibung

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

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Communicable Disease

Datentyp

boolean

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

CORTICOSTEROIDS FOR SYSTEMIC USE High dose Planned

Datentyp

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.
Beschreibung

Cancer treatment | Systemic therapy | Therapeutic radiology procedure

Datentyp

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.
Beschreibung

Immunotherapy | Monoclonal Antibodies

Datentyp

boolean

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

Therapeutic immunosuppression | Steroid therapy | Cyclosporine

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0149783
UMLS CUI [3]
C0010592
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Ähnliche Modelle

Eligibility Histological or Cytological Diagnosis of Pancreatic Carcinoma NCT01985958

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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