ID

35055

Description

Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02483767

Link

https://clinicaltrials.gov/show/NCT02483767

Keywords

  1. 2/12/19 2/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 12, 2019

DOI

To request one please log in.

License

Creative Commons BY 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.

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 Breast Cancer NCT02483767

Eligibility Breast Cancer NCT02483767

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients signed the written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
histologically proven stage i, ii, or iii breast cancer
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
must be candidates for adjuvant or neoadjuvant chemotherapy,
Description

Patients Appropriate Adjuvant Chemotherapy | Patients Appropriate Chemotherapy Neoadjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0085533
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C1298676
must be premenopausal.
Description

Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (her2) overexpressing tumors.
Description

trastuzumab | Tumor HER2 Overexpression

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0069515
UMLS CUI [2,3]
C1514559
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patients were previous chemotherapy;
Description

Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
evidence of distant metastases;
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
other malignancies in the previous 5 years.
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
the patients were using gnrha, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
Description

Gonadotropin releasing hormone agonists (GNRH-A) | Progesterone | Ovulation Stimulation Drugs | Contraceptives, Oral | Aromatase Inhibitors | Intrauterine Devices Hormonal | Subcutaneous contraceptive | Hormone Therapy Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2012324
UMLS CUI [2]
C0033308
UMLS CUI [3,1]
C0029965
UMLS CUI [3,2]
C1292856
UMLS CUI [3,3]
C0013227
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0593802
UMLS CUI [6,1]
C0021900
UMLS CUI [6,2]
C0458083
UMLS CUI [7]
C0459222
UMLS CUI [8,1]
C0279025
UMLS CUI [8,2]
C0013227
pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Similar models

Eligibility Breast Cancer NCT02483767

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
the patients signed the written informed consent.
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging
Item
histologically proven stage i, ii, or iii breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Patients Appropriate Adjuvant Chemotherapy | Patients Appropriate Chemotherapy Neoadjuvant
Item
must be candidates for adjuvant or neoadjuvant chemotherapy,
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C1298676 (UMLS CUI [2,4])
Premenopausal state
Item
must be premenopausal.
boolean
C0232969 (UMLS CUI [1])
trastuzumab | Tumor HER2 Overexpression
Item
trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (her2) overexpressing tumors.
boolean
C0728747 (UMLS CUI [1])
C0027651 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C1514559 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy
Item
the patients were previous chemotherapy;
boolean
C1514457 (UMLS CUI [1])
Distant metastasis
Item
evidence of distant metastases;
boolean
C1269798 (UMLS CUI [1])
Cancer Other
Item
other malignancies in the previous 5 years.
boolean
C1707251 (UMLS CUI [1])
Gonadotropin releasing hormone agonists (GNRH-A) | Progesterone | Ovulation Stimulation Drugs | Contraceptives, Oral | Aromatase Inhibitors | Intrauterine Devices Hormonal | Subcutaneous contraceptive | Hormone Therapy Drugs
Item
the patients were using gnrha, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
boolean
C2012324 (UMLS CUI [1])
C0033308 (UMLS CUI [2])
C0029965 (UMLS CUI [3,1])
C1292856 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C0021900 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
C0459222 (UMLS CUI [7])
C0279025 (UMLS CUI [8,1])
C0013227 (UMLS CUI [8,2])
Pregnancy | Breast Feeding
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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

Fields marked with * are required.

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