ID

14906

Description

Neck Dissection Via a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx; ODM derived from: https://clinicaltrials.gov/show/NCT02269020

Link

https://clinicaltrials.gov/show/NCT02269020

Keywords

Versions (1)
  1. 5/6/16 5/6/16 -
Uploaded on

May 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Squamous Cell NCT02269020

English

Eligibility Carcinoma, Squamous Cell NCT02269020

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cancer of the epi-larynx: (i) ranked t1 or t2 in the tnm classification, (ii) supraglottic or glotto-supraglottic location, (iii) cn0 nodal status
Description

Neoplasm of supraglottis | TNM category | Supraglottic space | Lymph nodal status

Data type

boolean

Alias
UMLS CUI [1]
C0345726
UMLS CUI [2]
C0809869
UMLS CUI [3]
C0225574
UMLS CUI [4]
C0449927
absence of distant metastasis (m0)
Description

Absent M0 category

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0445034
decision for unilateral endoscopic axillary neck dissection at lymph node levels iia, iii and iv of the robins classification is retained in a multidisciplinary meeting
Description

Neck Dissection Unilateral Endoscopic approach - access Axilla | Lymph node level value

Data type

boolean

Alias
UMLS CUI [1,1]
C0398395
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0442418
UMLS CUI [1,4]
C0004454
UMLS CUI [2]
C0441893
the patient is available for 6 months of follow-up
Description

Patient Availability Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C1522577
the patient must have given his/her informed and signed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the patient must be insured or beneficiary of a health insurance plan
Description

health insurance plan

Data type

boolean

Alias
UMLS CUI [1]
C0679933
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
adult under judicial protection or any kind of guardianship
Description

Adult | Protection judicial aspects | Guardianship

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C1545588
UMLS CUI [2,2]
C0243116
UMLS CUI [3]
C0870627
refusal to sign the consent
Description

Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
it is impossible to correctly inform the patient
Description

Patient Information Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C1955348
UMLS CUI [1,2]
C1272705
the patient is pregnant, parturient, or breastfeeding
Description

Pregnancy | Birth | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0005615
UMLS CUI [3]
C0006147
preoperative diagnosis of a second location of cancerous disease
Description

Malignant Neoplasms | Location second

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0450429
UMLS CUI [2,2]
C0205436
body mass index > 25
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
history of cervical spine surgery
Description

Cervical spine Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0728985
UMLS CUI [1,2]
C0543467
history of instability of the cervical spine
Description

Cervical spine Instability

Data type

boolean

Alias
UMLS CUI [1,1]
C0728985
UMLS CUI [1,2]
C1444783
history of surgery in the shoulder or pre-pectoral region
Description

Operative procedure on shoulder | Operative Surgical Procedures Anterior chest wall structure

Data type

boolean

Alias
UMLS CUI [1]
C0186321
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0230132
history of ipsilateral neck surgery
Description

Operative Surgical Procedures | Neck Ipsilateral

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0027530
UMLS CUI [2,2]
C0441989
history of cervical radiotherapy
Description

Therapeutic radiology procedure Neck

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0027530
history of breast implants
Description

breast implant procedure

Data type

boolean

Alias
UMLS CUI [1]
C0178391
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Similar models

Eligibility Carcinoma, Squamous Cell NCT02269020

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Neoplasm of supraglottis | TNM category | Supraglottic space | Lymph nodal status
Item
cancer of the epi-larynx: (i) ranked t1 or t2 in the tnm classification, (ii) supraglottic or glotto-supraglottic location, (iii) cn0 nodal status
boolean
C0345726 (UMLS CUI [1])
C0809869 (UMLS CUI [2])
C0225574 (UMLS CUI [3])
C0449927 (UMLS CUI [4])
Absent M0 category
Item
absence of distant metastasis (m0)
boolean
C0332197 (UMLS CUI [1,1])
C0445034 (UMLS CUI [1,2])
Neck Dissection Unilateral Endoscopic approach - access Axilla | Lymph node level value
Item
decision for unilateral endoscopic axillary neck dissection at lymph node levels iia, iii and iv of the robins classification is retained in a multidisciplinary meeting
boolean
C0398395 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0442418 (UMLS CUI [1,3])
C0004454 (UMLS CUI [1,4])
C0441893 (UMLS CUI [2])
Patient Availability Follow-up
Item
the patient is available for 6 months of follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
Informed Consent
Item
the patient must have given his/her informed and signed consent
boolean
C0021430 (UMLS CUI [1])
health insurance plan
Item
the patient must be insured or beneficiary of a health insurance plan
boolean
C0679933 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
patient participating in or having participated in another study within the previous 3 months or currently in an exclusion period determined by a previous study
boolean
C2348568 (UMLS CUI [1])
Adult | Protection judicial aspects | Guardianship
Item
adult under judicial protection or any kind of guardianship
boolean
C0001675 (UMLS CUI [1])
C1545588 (UMLS CUI [2,1])
C0243116 (UMLS CUI [2,2])
C0870627 (UMLS CUI [3])
Informed Consent Refused
Item
refusal to sign the consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Patient Information Unsuccessful
Item
it is impossible to correctly inform the patient
boolean
C1955348 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Pregnancy | Birth | Breast Feeding
Item
the patient is pregnant, parturient, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0005615 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Malignant Neoplasms | Location second
Item
preoperative diagnosis of a second location of cancerous disease
boolean
C0006826 (UMLS CUI [1])
C0450429 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Body mass index
Item
body mass index > 25
boolean
C1305855 (UMLS CUI [1])
Cervical spine Operative Surgical Procedures
Item
history of cervical spine surgery
boolean
C0728985 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Cervical spine Instability
Item
history of instability of the cervical spine
boolean
C0728985 (UMLS CUI [1,1])
C1444783 (UMLS CUI [1,2])
Operative procedure on shoulder | Operative Surgical Procedures Anterior chest wall structure
Item
history of surgery in the shoulder or pre-pectoral region
boolean
C0186321 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0230132 (UMLS CUI [2,2])
Operative Surgical Procedures | Neck Ipsilateral
Item
history of ipsilateral neck surgery
boolean
C0543467 (UMLS CUI [1])
C0027530 (UMLS CUI [2,1])
C0441989 (UMLS CUI [2,2])
Therapeutic radiology procedure Neck
Item
history of cervical radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C0027530 (UMLS CUI [1,2])
breast implant procedure
Item
history of breast implants
boolean
C0178391 (UMLS CUI [1])
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