ID

16193

Description

Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00080756

Link

https://clinicaltrials.gov/show/NCT00080756

Keywords

Versions (1)
  1. 7/4/16 7/4/16 -
Uploaded on

July 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility brca1 Mutation Carrier NCT00080756

English

Eligibility brca1 Mutation Carrier NCT00080756

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must generally be in good health with lab values and physical examination within normal limits
Description

General health good | Laboratory Results Normal | Physical Examination Normal

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0205307
known high risk of breast cancer due to brca mutation or empiric risk > 30% lifetime by the claus model
Description

At high risk for breast cancer Due to brca gene Mutation | Lifetime Risk Empiric Claus Model

Data type

boolean

Alias
UMLS CUI [1,1]
C4047809
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0596223
UMLS CUI [1,4]
C0026882
UMLS CUI [2,1]
C1517878
UMLS CUI [2,2]
C1880496
UMLS CUI [2,3]
C1707405
no evidence or history of pervious cancer, except non-melanoma skin cancer
Description

Malignant Neoplasms No evidence | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332125
UMLS CUI [2]
C0699893
premenopausal women planning risk reduction mastectomy in 6 months or more (group 1) or continued surveillance (group 2)
Description

Premenopausal Planning bilateral mastectomy for risk reduction | Premenopausal Continuous Surveillance

Data type

boolean

Alias
UMLS CUI [1,1]
C0279752
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C3838456
UMLS CUI [2,1]
C0279752
UMLS CUI [2,2]
C1999123
prior tubal ligation or willing to use a non-hormonal barrier method of contraception
Description

Tubal Ligation | Female barrier contraception method Willing

Data type

boolean

Alias
UMLS CUI [1]
C0520483
UMLS CUI [2,1]
C0558251
UMLS CUI [2,2]
C0600109
signed the informed consent form document for this study in accordance with all federal, state and institutional regulations
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
must be current non-smoker
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
gnrha treatment within 12 months of study entry
Description

gonadotropin releasing hormone agonists

Data type

boolean

Alias
UMLS CUI [1]
C2012324
nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
Description

Nasal Polyps | Rhinitis, Atrophic | Allergic rhinitis Severe | Vasomotor Rhinitis Severe | Sinusitis Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0027430
UMLS CUI [2]
C0035459
UMLS CUI [3,1]
C2607914
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0035460
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0037199
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0087111
concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, decadron, deltasone, hydrocortisone, hydrocortone, medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (at least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as norplant)
Description

Pharmaceutical Preparations | Adrenal Cortex Hormones | Prednisone | prednisolone | cortisone acetate | Decadron | Deltasone | Hydrocortisone | Hydrocortone | Medrol | Estrogens | Progestins | Androgens | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Norplant

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0032952
UMLS CUI [4]
C0032950
UMLS CUI [5]
C0056391
UMLS CUI [6]
C0740057
UMLS CUI [7]
C0740144
UMLS CUI [8]
C0020268
UMLS CUI [9]
C0699396
UMLS CUI [10]
C0699458
UMLS CUI [11]
C0014939
UMLS CUI [12]
C0033306
UMLS CUI [13]
C0002844
UMLS CUI [14]
C0009905
UMLS CUI [15]
C1657106
UMLS CUI [16]
C1656586
UMLS CUI [17]
C1145675
pregnant or breast-feeding or have been so in the last six months
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
immeasurable breast density on mammogram
Description

Mammography Breast Density Non-Measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0024671
UMLS CUI [1,2]
C1659543
UMLS CUI [1,3]
C1518373
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Similar models

Eligibility brca1 Mutation Carrier NCT00080756

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
General health good | Laboratory Results Normal | Physical Examination Normal
Item
patients must generally be in good health with lab values and physical examination within normal limits
boolean
C1277245 (UMLS CUI [1])
C1254595 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
At high risk for breast cancer Due to brca gene Mutation | Lifetime Risk Empiric Claus Model
Item
known high risk of breast cancer due to brca mutation or empiric risk > 30% lifetime by the claus model
boolean
C4047809 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0596223 (UMLS CUI [1,3])
C0026882 (UMLS CUI [1,4])
C1517878 (UMLS CUI [2,1])
C1880496 (UMLS CUI [2,2])
C1707405 (UMLS CUI [2,3])
Malignant Neoplasms No evidence | Skin carcinoma
Item
no evidence or history of pervious cancer, except non-melanoma skin cancer
boolean
C0006826 (UMLS CUI [1,1])
C0332125 (UMLS CUI [1,2])
C0699893 (UMLS CUI [2])
Premenopausal Planning bilateral mastectomy for risk reduction | Premenopausal Continuous Surveillance
Item
premenopausal women planning risk reduction mastectomy in 6 months or more (group 1) or continued surveillance (group 2)
boolean
C0279752 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3838456 (UMLS CUI [1,3])
C0279752 (UMLS CUI [2,1])
C1999123 (UMLS CUI [2,2])
Tubal Ligation | Female barrier contraception method Willing
Item
prior tubal ligation or willing to use a non-hormonal barrier method of contraception
boolean
C0520483 (UMLS CUI [1])
C0558251 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed consent
Item
signed the informed consent form document for this study in accordance with all federal, state and institutional regulations
boolean
C0021430 (UMLS CUI [1])
Non-smoker
Item
must be current non-smoker
boolean
C0337672 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
gonadotropin releasing hormone agonists
Item
gnrha treatment within 12 months of study entry
boolean
C2012324 (UMLS CUI [1])
Nasal Polyps | Rhinitis, Atrophic | Allergic rhinitis Severe | Vasomotor Rhinitis Severe | Sinusitis Requirement Therapeutic procedure
Item
nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year
boolean
C0027430 (UMLS CUI [1])
C0035459 (UMLS CUI [2])
C2607914 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0035460 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0037199 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0087111 (UMLS CUI [5,3])
Pharmaceutical Preparations | Adrenal Cortex Hormones | Prednisone | prednisolone | cortisone acetate | Decadron | Deltasone | Hydrocortisone | Hydrocortone | Medrol | Estrogens | Progestins | Androgens | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Norplant
Item
concurrent medications including: corticosteroids (prednisone, prednisolone, cortisone acetate, decadron, deltasone, hydrocortisone, hydrocortone, medrol), estrogens, progestins or androgens, including oral, implanted, or injected contraceptive; (at least 6 months must have elapsed since the last use of an implanted or injected contraceptive such as norplant)
boolean
C0013227 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0032952 (UMLS CUI [3])
C0032950 (UMLS CUI [4])
C0056391 (UMLS CUI [5])
C0740057 (UMLS CUI [6])
C0740144 (UMLS CUI [7])
C0020268 (UMLS CUI [8])
C0699396 (UMLS CUI [9])
C0699458 (UMLS CUI [10])
C0014939 (UMLS CUI [11])
C0033306 (UMLS CUI [12])
C0002844 (UMLS CUI [13])
C0009905 (UMLS CUI [14])
C1657106 (UMLS CUI [15])
C1656586 (UMLS CUI [16])
C1145675 (UMLS CUI [17])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding or have been so in the last six months
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mammography Breast Density Non-Measurable
Item
immeasurable breast density on mammogram
boolean
C0024671 (UMLS CUI [1,1])
C1659543 (UMLS CUI [1,2])
C1518373 (UMLS CUI [1,3])
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