ID

23486

Beskrivning

A Biological Sample Collection Protocol of Women With and Without Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00472589

Länk

https://clinicaltrials.gov/show/NCT00472589

Nyckelord

Versioner (1)
  1. 2017-07-07 2017-07-07 -
Uppladdad den

7 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00472589

Engelsk

Eligibility Breast Cancer NCT00472589

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
for women with breast cancer
Beskrivning

Gender | Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0678222
histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
Beskrivning

invasive cancer | Noninfiltrating Intraductal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0007124
preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
Beskrivning

Adjuvant therapy Breast Carcinoma | New therapy Breast cancer recurrent Local | New therapy Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C3242274
UMLS CUI [2,2]
C0278493
UMLS CUI [2,3]
C0205276
UMLS CUI [3,1]
C3242274
UMLS CUI [3,2]
C0346993
female.
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
age > 18 years at the time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent and hipaa authorization for release of personal health information.
Beskrivning

Informed Consent | Authorization for Release of Confidential Health Information

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2346880
for healthy volunteers
Beskrivning

Healthy Volunteers

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
no known history of invasive malignancy or ductal carcinoma in situ. volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. other cancers with low potential for metastasis, such as in situ cancers (e.g., grade 1, ta tcc (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
Beskrivning

invasive cancer Absent | Noninfiltrating Intraductal Carcinoma Absent | Malignant Neoplasms Absent | Basal cell carcinoma | Squamous cell carcinoma of skin | Neoplasm Metastasis Potential low | In situ cancer TNM clinical staging | Carcinoma of bladder TNM clinical staging | Colonic Polyps | Adenocarcinoma of colon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677898
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C0007117
UMLS CUI [5]
C0553723
UMLS CUI [6,1]
C0027627
UMLS CUI [6,2]
C3245505
UMLS CUI [6,3]
C0205251
UMLS CUI [7,1]
C0851135
UMLS CUI [7,2]
C3258246
UMLS CUI [8,1]
C0699885
UMLS CUI [8,2]
C3258246
UMLS CUI [9]
C0009376
UMLS CUI [10]
C0338106
female
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
age > 18 years at the time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent and hipaa authorization for release of personal health information.
Beskrivning

Informed Consent | Authorization for Release of Confidential Health Information

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2346880
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
females must not be pregnant.
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Cancer NCT00472589

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma
Item
for women with breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
invasive cancer | Noninfiltrating Intraductal Carcinoma
Item
histologically or cytologically confirmed invasive malignancy or ductal carcinoma in situ of the breast.
boolean
C0677898 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
Adjuvant therapy Breast Carcinoma | New therapy Breast cancer recurrent Local | New therapy Secondary malignant neoplasm of female breast
Item
preparing to begin a new regimen for breast cancer (adjuvant, locally recurrent, any line metastatic).
boolean
C0677850 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C3242274 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C3242274 (UMLS CUI [3,1])
C0346993 (UMLS CUI [3,2])
Gender
Item
female.
boolean
C0079399 (UMLS CUI [1])
Age
Item
age > 18 years at the time of consent.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Authorization for Release of Confidential Health Information
Item
written informed consent and hipaa authorization for release of personal health information.
boolean
C0021430 (UMLS CUI [1])
C2346880 (UMLS CUI [2])
Healthy Volunteers
Item
for healthy volunteers
boolean
C1708335 (UMLS CUI [1])
invasive cancer Absent | Noninfiltrating Intraductal Carcinoma Absent | Malignant Neoplasms Absent | Basal cell carcinoma | Squamous cell carcinoma of skin | Neoplasm Metastasis Potential low | In situ cancer TNM clinical staging | Carcinoma of bladder TNM clinical staging | Colonic Polyps | Adenocarcinoma of colon
Item
no known history of invasive malignancy or ductal carcinoma in situ. volunteers must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. other cancers with low potential for metastasis, such as in situ cancers (e.g., grade 1, ta tcc (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled as healthy volunteers.
boolean
C0677898 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0007117 (UMLS CUI [4])
C0553723 (UMLS CUI [5])
C0027627 (UMLS CUI [6,1])
C3245505 (UMLS CUI [6,2])
C0205251 (UMLS CUI [6,3])
C0851135 (UMLS CUI [7,1])
C3258246 (UMLS CUI [7,2])
C0699885 (UMLS CUI [8,1])
C3258246 (UMLS CUI [8,2])
C0009376 (UMLS CUI [9])
C0338106 (UMLS CUI [10])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age > 18 years at the time of consent.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Authorization for Release of Confidential Health Information
Item
written informed consent and hipaa authorization for release of personal health information.
boolean
C0021430 (UMLS CUI [1])
C2346880 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
females must not be pregnant.
boolean
C0032961 (UMLS CUI [1])
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