ID

16509

Beschreibung

Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary; ODM derived from: https://clinicaltrials.gov/show/NCT00126269

Link

https://clinicaltrials.gov/show/NCT00126269

Stichworte

Versionen (1)
  1. 21.07.16 21.07.16 -
Hochgeladen am

21. Juli 2016

DOI

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Creative Commons BY 4.0
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Eligibility Carcinoma NCT00126269

Englisch

Eligibility Carcinoma NCT00126269

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00126269
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients older than 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
evidence of cup based on histologic examination
Beschreibung

Carcinoma of unknown primary Evidence of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220647
UMLS CUI [1,2]
C0332120
negative search for the primary tumor site using recommended guidelines
Beschreibung

Primary tumor site Search Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0475447
UMLS CUI [1,2]
C1706202
UMLS CUI [1,3]
C0205160
disease classified as good prognosis according to the french classification criteria:
Beschreibung

Disease Prognosis good

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0278250
*performance status >2 and *normal serum ldh
Beschreibung

performance status | Serum lactate dehydrogenase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2]
C1278052
no prior chemotherapy
Beschreibung

Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
no previous carcinoma, except basal-cell carcinoma of the skin
Beschreibung

Carcinoma | Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0007097
UMLS CUI [2]
C0007117
adequate renal function: measured or calculated creatinine clearance > 60 ml/min
Beschreibung

Renal function | Creatinine clearance, ml/min | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0151280
UMLS CUI [3]
C0373595
absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
Beschreibung

Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C1278039
signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients infected by the human immunodeficiency virus (hiv)
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
cup belonging to one of the following subgroups: 1) axillary lymph node of an adenocarcinoma in a woman; 2) serous adenocarcinoma of the peritoneum in a woman; 3) undifferentiated carcinoma of the middle line in a young man; 4)squamous-cell carcinoma; 5) neuroendocrine carcinoma; 6) bone metastases with elevated serum prostate specific antigen (psa) in a man
Beschreibung

Carcinoma of unknown primary | Gender | Adenocarcinoma Axillary lymph nodes | Primary Peritoneal Serous Adenocarcinoma | NUT Midline Carcinoma | Squamous cell carcinoma | Carcinoma, Neuroendocrine | Secondary malignant neoplasm of bone | Serum Prostate Specific Antigen Increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0220647
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0001418
UMLS CUI [3,2]
C0729594
UMLS CUI [4]
C1514429
UMLS CUI [5]
C1707291
UMLS CUI [6]
C0007137
UMLS CUI [7]
C0206695
UMLS CUI [8]
C0153690
UMLS CUI [9]
C1883014
patients who do not fit inclusion criteria.
Beschreibung

Inclusion criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
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Ähnliche Modelle

Eligibility Carcinoma NCT00126269

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00126269
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients older than 18 years
boolean
C0001779 (UMLS CUI [1])
Carcinoma of unknown primary Evidence of
Item
evidence of cup based on histologic examination
boolean
C0220647 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Primary tumor site Search Negative
Item
negative search for the primary tumor site using recommended guidelines
boolean
C0475447 (UMLS CUI [1,1])
C1706202 (UMLS CUI [1,2])
C0205160 (UMLS CUI [1,3])
Disease Prognosis good
Item
disease classified as good prognosis according to the french classification criteria:
boolean
C0012634 (UMLS CUI [1,1])
C0278250 (UMLS CUI [1,2])
performance status | Serum lactate dehydrogenase measurement
Item
*performance status >2 and *normal serum ldh
boolean
C1518965 (UMLS CUI [1])
C1278052 (UMLS CUI [2])
Prior Chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Carcinoma | Basal cell carcinoma
Item
no previous carcinoma, except basal-cell carcinoma of the skin
boolean
C0007097 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Renal function | Creatinine clearance, ml/min | Creatinine clearance measurement
Item
adequate renal function: measured or calculated creatinine clearance > 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0151280 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement
Item
absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infection
Item
patients infected by the human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Carcinoma of unknown primary | Gender | Adenocarcinoma Axillary lymph nodes | Primary Peritoneal Serous Adenocarcinoma | NUT Midline Carcinoma | Squamous cell carcinoma | Carcinoma, Neuroendocrine | Secondary malignant neoplasm of bone | Serum Prostate Specific Antigen Increased
Item
cup belonging to one of the following subgroups: 1) axillary lymph node of an adenocarcinoma in a woman; 2) serous adenocarcinoma of the peritoneum in a woman; 3) undifferentiated carcinoma of the middle line in a young man; 4)squamous-cell carcinoma; 5) neuroendocrine carcinoma; 6) bone metastases with elevated serum prostate specific antigen (psa) in a man
boolean
C0220647 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001418 (UMLS CUI [3,1])
C0729594 (UMLS CUI [3,2])
C1514429 (UMLS CUI [4])
C1707291 (UMLS CUI [5])
C0007137 (UMLS CUI [6])
C0206695 (UMLS CUI [7])
C0153690 (UMLS CUI [8])
C1883014 (UMLS CUI [9])
Inclusion criteria Fulfill
Item
patients who do not fit inclusion criteria.
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
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