ID

16382

Beschreibung

Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00427245

Link

https://clinicaltrials.gov/show/NCT00427245

Stichworte

Versionen (1)
  1. 14.07.16 14.07.16 -
Hochgeladen am

14. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00427245

Englisch

Eligibility Breast Cancer NCT00427245

1 Formulare  
Criteria
Beschreibung

Criteria

histologically confirmed invasive breast cancer
Beschreibung

Invasive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
stages i-iiib with node-positive or -negative disease (n0-2)
Beschreibung

TNM clinical staging | Node-positive breast cancer | Node-negative breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C3160887
UMLS CUI [3]
C3160889
operable disease
Beschreibung

Disease Operable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205188
must meet 1 of the following criteria:
Beschreibung

criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
Beschreibung

Mastectomy | Breast-Conserving Surgery | Complete excision primary tumor

Datentyp

boolean

Alias
UMLS CUI [1]
C0024881
UMLS CUI [2]
C0917927
UMLS CUI [3,1]
C0015250
UMLS CUI [3,2]
C0677930
scheduled to receive neoadjuvant chemotherapy
Beschreibung

Neoadjuvant Chemotherapy Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1301732
no metastatic breast cancer, including supraclavicular fossa metastases
Beschreibung

Carcinoma breast stage IV | Neoplasm Metastasis Fossa supraclavicular

Datentyp

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0836913
UMLS CUI [2,3]
C0446461
hormone receptor status meeting 1 of the following criteria:
Beschreibung

Hormone Receptor Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
estrogen receptor (er) and progesterone receptor poor or negative and not a candidate for adjuvant endocrine therapy
Beschreibung

Estrogen Receptors Poor | Progesterone Receptors Poor | Estrogen receptor negative | progesterone receptor negative | Indication Hormone Therapy Adjuvant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0542537
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C0542537
UMLS CUI [3]
C0279756
UMLS CUI [4]
C0279766
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0279025
UMLS CUI [5,3]
C1522673
er positive and no requirement for ovarian suppression as a necessary part of treatment
Beschreibung

Estrogen receptor positive Requirement Ovarian suppression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279754
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0677922
patient characteristics:
Beschreibung

patient characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
premenopausal with regular menses in the 12 months preceding surgery
Beschreibung

Premenopausal | Normal menstruation Before Operative Surgical Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0279752
UMLS CUI [2,1]
C0559892
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0543467
no other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Beschreibung

Malignant Neoplasms Invasive | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0553723
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
UMLS CUI [4,1]
C0851140
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C0205411
suitable fitness status for chemotherapy
Beschreibung

Fitness suitable Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031812
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C0392920
adequate hepatic, renal, and bone marrow function
Beschreibung

Liver function | Renal function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C0031843
not pregnant or nursing
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
fertile patients must use effective contraception
Beschreibung

Fertility Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
prior concurrent therapy:
Beschreibung

concurrent therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0009429
see disease characteristics
Beschreibung

disease characteristic

Datentyp

boolean

Alias
UMLS CUI [1]
C0599878
no prior chemotherapy or endocrine therapy
Beschreibung

Prior Chemotherapy | Prior Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1514460
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Ähnliche Modelle

Eligibility Breast Cancer NCT00427245

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Invasive carcinoma of breast
Item
histologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
TNM clinical staging | Node-positive breast cancer | Node-negative breast cancer
Item
stages i-iiib with node-positive or -negative disease (n0-2)
boolean
C3258246 (UMLS CUI [1])
C3160887 (UMLS CUI [2])
C3160889 (UMLS CUI [3])
Disease Operable
Item
operable disease
boolean
C0012634 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
criteria Fulfill
Item
must meet 1 of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Mastectomy | Breast-Conserving Surgery | Complete excision primary tumor
Item
has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
boolean
C0024881 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
C0015250 (UMLS CUI [3,1])
C0677930 (UMLS CUI [3,2])
Neoadjuvant Chemotherapy Planned
Item
scheduled to receive neoadjuvant chemotherapy
boolean
C0600558 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Carcinoma breast stage IV | Neoplasm Metastasis Fossa supraclavicular
Item
no metastatic breast cancer, including supraclavicular fossa metastases
boolean
C0278488 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0836913 (UMLS CUI [2,2])
C0446461 (UMLS CUI [2,3])
Hormone Receptor Status
Item
hormone receptor status meeting 1 of the following criteria:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Estrogen Receptors Poor | Progesterone Receptors Poor | Estrogen receptor negative | progesterone receptor negative | Indication Hormone Therapy Adjuvant
Item
estrogen receptor (er) and progesterone receptor poor or negative and not a candidate for adjuvant endocrine therapy
boolean
C0034804 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0034833 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0279756 (UMLS CUI [3])
C0279766 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0279025 (UMLS CUI [5,2])
C1522673 (UMLS CUI [5,3])
Estrogen receptor positive Requirement Ovarian suppression
Item
er positive and no requirement for ovarian suppression as a necessary part of treatment
boolean
C0279754 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0677922 (UMLS CUI [1,3])
patient characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Premenopausal | Normal menstruation Before Operative Surgical Procedure
Item
premenopausal with regular menses in the 12 months preceding surgery
boolean
C0279752 (UMLS CUI [1])
C0559892 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Malignant Neoplasms Invasive | Basal cell carcinoma Treated Adequate | Squamous cell carcinoma of skin Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
no other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0553723 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
C0851140 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0205411 (UMLS CUI [4,3])
Fitness suitable Chemotherapy
Item
suitable fitness status for chemotherapy
boolean
C0031812 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Liver function | Renal function | Bone Marrow function
Item
adequate hepatic, renal, and bone marrow function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
concurrent therapy
Item
prior concurrent therapy:
boolean
C0009429 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
Prior Chemotherapy | Prior Hormone Therapy
Item
no prior chemotherapy or endocrine therapy
boolean
C1514457 (UMLS CUI [1])
C1514460 (UMLS CUI [2])
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