ID

42490

Description

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02007200

Link

https://clinicaltrials.gov/show/NCT02007200

Keywords

Versions (1)
  1. 7/28/21 7/28/21 -
Copyright Holder

National Cancer Institute (NCI)

Uploaded on

July 28, 2021

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02007200

English

Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02007200

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
Description

Pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx

Data type

boolean

Alias
UMLS CUI [1,1]
C0007137
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C0226896
UMLS CUI [1,4]
C1514888
UMLS CUI [2,1]
C0007137
UMLS CUI [2,2]
C0679557
UMLS CUI [2,3]
C1280659
UMLS CUI [2,4]
C1514888
UMLS CUI [3,1]
C0007137
UMLS CUI [3,2]
C0679557
UMLS CUI [3,3]
C0020629
UMLS CUI [3,4]
C1514888
UMLS CUI [4,1]
C0007137
UMLS CUI [4,2]
C0679557
UMLS CUI [4,3]
C0023078
UMLS CUI [4,4]
C1514888
disease must be stage i, ii, iii or iva
Description

Diagnostic Neoplasm Staging

Data type

boolean

Alias
UMLS CUI [1]
C0027646
tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
Description

Neoplasm surgically resectable | Curable with conventional surgery | Curable with radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1514888
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C1276305
UMLS CUI [2,4]
C0332149
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C1276305
UMLS CUI [3,4]
C0332149
eastern cooperative oncology group (ecog) performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must give documented informed consent to participate in this study
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
documented evidence of distant metastases
Description

Evidence of distant metastases

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
Description

Acute serious commorbidity that would preclude surgical resection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205178
UMLS CUI [1,3]
C0205404
UMLS CUI [1,4]
C0543467
UMLS CUI [1,5]
C1299582
pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
Description

Patients of childbearing potential must be willing to use Hormonal contraceptives or Barriere method of contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0009905
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C0600109
a medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
Description

Comorbidity which could interfere with patient's protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
patients residing in prison
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
any patient with a history of breast or ovarian cancer
Description

Medical history of breast cancer | Medical history of ovarian cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0029925
UMLS CUI [2,2]
C0262926
allergy to soy products
Description

Hypersensitivity to soy products

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1532456
Back to the top of the page

Similar models

Eligibility Recurrent Hypopharyngeal Squamous Cell Carcinoma NCT02007200

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
Item
patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
boolean
C0007137 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C0226896 (UMLS CUI [1,3])
C1514888 (UMLS CUI [1,4])
C0007137 (UMLS CUI [2,1])
C0679557 (UMLS CUI [2,2])
C1280659 (UMLS CUI [2,3])
C1514888 (UMLS CUI [2,4])
C0007137 (UMLS CUI [3,1])
C0679557 (UMLS CUI [3,2])
C0020629 (UMLS CUI [3,3])
C1514888 (UMLS CUI [3,4])
C0007137 (UMLS CUI [4,1])
C0679557 (UMLS CUI [4,2])
C0023078 (UMLS CUI [4,3])
C1514888 (UMLS CUI [4,4])
Diagnostic Neoplasm Staging
Item
disease must be stage i, ii, iii or iva
boolean
C0027646 (UMLS CUI [1])
Neoplasm surgically resectable | Curable with conventional surgery | Curable with radiation therapy
Item
tumor must be potentially surgically resectable and curable with conventional surgery and radiation therapy
boolean
C0027651 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C1276305 (UMLS CUI [2,3])
C0332149 (UMLS CUI [2,4])
C0027651 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C0332149 (UMLS CUI [3,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Informed consent
Item
patients must give documented informed consent to participate in this study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Evidence of distant metastases
Item
documented evidence of distant metastases
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Acute serious commorbidity that would preclude surgical resection
Item
ongoing acute medical condition such as uncontrolled coronary artery disease, emphysema, or diabetes mellitus that would preclude surgical resection
boolean
C0009488 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C1299582 (UMLS CUI [1,5])
Patients of childbearing potential must be willing to use Hormonal contraceptives or Barriere method of contraception
Item
pregnancy or lactation; patients of child bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of soy administration
boolean
C3831118 (UMLS CUI [1,1])
C0009905 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Comorbidity which could interfere with patient's protocol compliance
Item
a medical or psychiatric illness which would compromise the patient's ability to tolerate this treatment or comply with administration of study drug
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Prisoners
Item
patients residing in prison
boolean
C0033167 (UMLS CUI [1])
Medical history of breast cancer | Medical history of ovarian cancer
Item
any patient with a history of breast or ovarian cancer
boolean
C0678222 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0029925 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
Hypersensitivity to soy products
Item
allergy to soy products
boolean
C0020517 (UMLS CUI [1,1])
C1532456 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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