ID

44233

Description

Prediction of Everolimus-induced Interstitial Lung Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01978171

Link

https://clinicaltrials.gov/show/NCT01978171

Keywords

Versions (2)
  1. 2/14/19 2/14/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01978171

English

Eligibility Breast Neoplasms NCT01978171

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
Description

Adult | Gender | Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0346993
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C3495949
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1511562
UMLS CUI [5,1]
C0346993
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C1522449
UMLS CUI [5,4]
C1276305
UMLS CUI [6,1]
C3495949
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C1522449
UMLS CUI [6,4]
C1276305
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
Description

Oestrogen receptor positive breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C2938924
postmenopausal women
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment
Description

Recurrence | Disease Progression | Systemic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0034897
UMLS CUI [2]
C0242656
UMLS CUI [3]
C1515119
resistance to treatment with a non-steroidal aromatase inhibitor
Description

Resistant to Non-Steroidal Aromatase Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0332325
UMLS CUI [1,2]
C1518386
serum platelets ≥ 100x10e9/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
everolimus dose adjustment is recommended for patients with hepatic impairment (child-pugh a/b/c)
Description

Everolimus Dose Adjustment Recommended | Hepatic impairment Child-Pugh Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0541315
UMLS CUI [1,2]
C2826232
UMLS CUI [1,3]
C0034866
UMLS CUI [2,1]
C0948807
UMLS CUI [2,2]
C4050412
performance status ecog 0 - 2 (karnofsky index: 60 - 100)
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a her2-overexpressing tumor
Description

Neoplasm HER2 Overexpression

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1514559
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
Description

Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1515672
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0072980
patients with a known history of hiv seropositivity or hepatitis b or c
Description

HIV Seropositivity | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
uncontrolled diabetes mellitus
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Description

Impaired gastrointestinal system function | Gastrointestinal Disease Changing Absorption Investigational New Drugs | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
UMLS CUI [3]
C0041582
UMLS CUI [4,1]
C0027497
UMLS CUI [4,2]
C0205318
UMLS CUI [5]
C0042963
UMLS CUI [6]
C0011991
UMLS CUI [7]
C0024523
patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cyp3a
Description

CYP3A Inhibitors | CYP3A Inducers

Data type

boolean

Alias
UMLS CUI [1]
C3850056
UMLS CUI [2]
C3850044
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Similar models

Eligibility Breast Neoplasms NCT01978171

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative
Item
adult women with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0346993 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1511562 (UMLS CUI [4,3])
C0346993 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C3495949 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C1522449 (UMLS CUI [6,3])
C1276305 (UMLS CUI [6,4])
Oestrogen receptor positive breast cancer
Item
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Recurrence | Disease Progression | Systemic therapy
Item
radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment
boolean
C0034897 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C1515119 (UMLS CUI [3])
Resistant to Non-Steroidal Aromatase Inhibitor
Item
resistance to treatment with a non-steroidal aromatase inhibitor
boolean
C0332325 (UMLS CUI [1,1])
C1518386 (UMLS CUI [1,2])
Platelet Count measurement
Item
serum platelets ≥ 100x10e9/l
boolean
C0032181 (UMLS CUI [1])
Everolimus Dose Adjustment Recommended | Hepatic impairment Child-Pugh Classification
Item
everolimus dose adjustment is recommended for patients with hepatic impairment (child-pugh a/b/c)
boolean
C0541315 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
C0034866 (UMLS CUI [1,3])
C0948807 (UMLS CUI [2,1])
C4050412 (UMLS CUI [2,2])
ECOG performance status | Karnofsky Performance Status
Item
performance status ecog 0 - 2 (karnofsky index: 60 - 100)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Neoplasm HER2 Overexpression
Item
patients with a her2-overexpressing tumor
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C1515672 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
HIV Seropositivity | Hepatitis B | Hepatitis C
Item
patients with a known history of hiv seropositivity or hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Impaired gastrointestinal system function | Gastrointestinal Disease Changing Absorption Investigational New Drugs | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome
Item
impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0041582 (UMLS CUI [3])
C0027497 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042963 (UMLS CUI [5])
C0011991 (UMLS CUI [6])
C0024523 (UMLS CUI [7])
CYP3A Inhibitors | CYP3A Inducers
Item
patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cyp3a
boolean
C3850056 (UMLS CUI [1])
C3850044 (UMLS CUI [2])
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