ID

27384

Beschrijving

Anatomical Relationship of Level IB Lymph Nodes to the Submandibular Gland in Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00728130

Link

https://clinicaltrials.gov/show/NCT00728130

Trefwoorden

Versies (1)
  1. 2017-11-10 2017-11-10 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Carcinoma NCT00728130

Engels

Eligibility Carcinoma NCT00728130

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00728130
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically or cytologically confirmed carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
Beschrijving

Oral Cavity Carcinoma | Oropharyngeal Carcinoma | Carcinoma of larynx | Hypopharyngeal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0151546
UMLS CUI [2]
C2349952
UMLS CUI [3]
C0595989
UMLS CUI [4]
C1368404
treatment of the regional lymph nodes to include neck dissection performed as the primary modality
Beschrijving

Therapeutic procedure Regional group of lymph nodes | Neck Dissection Modality Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1179441
UMLS CUI [2,1]
C0398395
UMLS CUI [2,2]
C0695347
UMLS CUI [2,3]
C0205225
no previous treatment to the neck
Beschrijving

Prior Therapy Absent Neck

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0027530
no previous treatment for the index cancer (surgery, chemotherapy, radiation or biological therapy)
Beschrijving

Prior Therapy Absent Malignant Neoplasm Involved | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Biological treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C1314939
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C1531518
no known distant metastatic disease
Beschrijving

Distant metastasis Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0332197
age >/= 18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
the ability to understand and willingness to sign a study-specific written informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
protocol treatment must begin </= 8 weeks of diagnostic biopsy
Beschrijving

Study Protocol Therapeutic procedure Started

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1272689
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous or concurrent head and neck primaries
Beschrijving

Primary tumor Head | Primary tumor Neck

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0018670
UMLS CUI [2,1]
C0677930
UMLS CUI [2,2]
C0027530
prior surgery to study site other than biopsy
Beschrijving

Prior surgery Site Involved | Exception Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0455610
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1314939
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0005558
patients receiving any other treatment for cancer within 30 days previously
Beschrijving

Cancer treatment Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
Beschrijving

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | Social situation Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C1321605
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C1321605
UMLS CUI [7,3]
C0439801
known allergy to lymphazurin®
Beschrijving

Hypersensitivity Lymphazurin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0126378
pregnant or breast feeding females
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Carcinoma NCT00728130

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Carcinoma NCT00728130
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Oral Cavity Carcinoma | Oropharyngeal Carcinoma | Carcinoma of larynx | Hypopharyngeal Carcinoma
Item
patients must have histologically or cytologically confirmed carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
boolean
C0151546 (UMLS CUI [1])
C2349952 (UMLS CUI [2])
C0595989 (UMLS CUI [3])
C1368404 (UMLS CUI [4])
Therapeutic procedure Regional group of lymph nodes | Neck Dissection Modality Primary
Item
treatment of the regional lymph nodes to include neck dissection performed as the primary modality
boolean
C0087111 (UMLS CUI [1,1])
C1179441 (UMLS CUI [1,2])
C0398395 (UMLS CUI [2,1])
C0695347 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Prior Therapy Absent Neck
Item
no previous treatment to the neck
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027530 (UMLS CUI [1,3])
Prior Therapy Absent Malignant Neoplasm Involved | Operative Surgical Procedures | Chemotherapy | Therapeutic radiology procedure | Biological treatment
Item
no previous treatment for the index cancer (surgery, chemotherapy, radiation or biological therapy)
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C1531518 (UMLS CUI [5])
Distant metastasis Absent
Item
no known distant metastatic disease
boolean
C1269798 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age >/= 18
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
the ability to understand and willingness to sign a study-specific written informed consent form
boolean
C0021430 (UMLS CUI [1])
Study Protocol Therapeutic procedure Started
Item
protocol treatment must begin </= 8 weeks of diagnostic biopsy
boolean
C2348563 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1272689 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Primary tumor Head | Primary tumor Neck
Item
previous or concurrent head and neck primaries
boolean
C0677930 (UMLS CUI [1,1])
C0018670 (UMLS CUI [1,2])
C0677930 (UMLS CUI [2,1])
C0027530 (UMLS CUI [2,2])
Prior surgery Site Involved | Exception Biopsy
Item
prior surgery to study site other than biopsy
boolean
C0455610 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Cancer treatment Other
Item
patients receiving any other treatment for cancer within 30 days previously
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Compliance behavior Limited | Social situation Compliance behavior Limited
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C1321605 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C1321605 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Hypersensitivity Lymphazurin
Item
known allergy to lymphazurin®
boolean
C0020517 (UMLS CUI [1,1])
C0126378 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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