ID

38080

Description

Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01612871

Link

https://clinicaltrials.gov/show/NCT01612871

Keywords

Versions (1)
  1. 9/16/19 9/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01612871

English

Eligibility Breast Cancer NCT01612871

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women of more than 18 years old (menopausal or not)
Description

Gender | Age | Menopausal state | Menopausal state Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0025320
UMLS CUI [4,1]
C0025320
UMLS CUI [4,2]
C0332197
2. women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase
Description

Gender | Invasive carcinoma of breast metastatic | Locally advanced breast cancer | Surgery Plan Absent | Indication Tamoxifen | Indication Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
UMLS CUI [3]
C3495949
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C1301732
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0039286
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C0593802
+/- lh-rh agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens).
Description

In addition to LH-RH Agonist | LH-RH Agonist Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0332287
UMLS CUI [1,2]
C1518041
UMLS CUI [2,1]
C1518041
UMLS CUI [2,2]
C0332197
3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (>= 10% of tumor cells by ihc technique).
Description

Tumor Hormone Expression Estrogen Receptor | Tumor Hormone Expression Progesterone Receptor | Tumor Cell Percentage Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0019932
UMLS CUI [1,3]
C0017262
UMLS CUI [1,4]
C0034804
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0019932
UMLS CUI [2,3]
C0017262
UMLS CUI [2,4]
C0034833
UMLS CUI [3,1]
C0597032
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0021044
cancer her2 negative.
Description

Neoplasm HER2 Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C2348908
4. evaluable disease (measurable according recist criteria or not)
Description

Evaluable Disease | Measurable Disease | Non-Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
UMLS CUI [3]
C1334988
5. any previous adjuvant hormone therapy should be discontinued for at least 21 days.
Description

Hormone Therapy Adjuvant To be stopped

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [1,3]
C1272691
6. one or two prior metastatic lines of chemotherapy are allowed
Description

Chemotherapy Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
7. general status who 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
8. the women of childbearing age must use an effective contraception for the duration of the study
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
9. informed consent obtained and signed before any specific study procedure
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
10. patient member in a national insurance scheme
Description

Patient Member National Health Insurance

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0680022
UMLS CUI [1,3]
C0027452
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
Description

Hormone Therapy Pre-existing | Lacking Discontinuation Hormone Therapy Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0279025
UMLS CUI [2,4]
C1522673
2. prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
Description

Prescription Chemotherapy Breast Carcinoma | Prescription Targeted Therapy Breast Carcinoma | Exception Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0033080
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C0033080
UMLS CUI [2,2]
C2985566
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
3. any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
Description

Hormone Therapy Secondary malignant neoplasm of female breast | Hormone Therapy Locally advanced breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C3495949
4. known hypercalcaemia before mirna dosage at t=0 requiring immediate biphosphonate therapy
Description

Hypercalcemia | Status pre- miRNA Dosage | Requirement Diphosphonates

Data type

boolean

Alias
UMLS CUI [1]
C0020437
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1101610
UMLS CUI [2,3]
C0178602
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0012544
5. any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator.
Description

Other medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Severe Study Subject Participation Status Inappropriate | Laboratory test result abnormal chronic Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
UMLS CUI [3,1]
C0438215
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C1548788
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C2348568
UMLS CUI [4,4]
C1548788
6. patient unable to follow procedures, visits, examinations described in the study.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
7. pregnant women or nursing mothers will not participate in the study.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patients under legal guardianship
Description

Patients Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
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Similar models

Eligibility Breast Cancer NCT01612871

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Menopausal state | Menopausal state Absent
Item
1. women of more than 18 years old (menopausal or not)
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0025320 (UMLS CUI [3])
C0025320 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Gender | Invasive carcinoma of breast metastatic | Locally advanced breast cancer | Surgery Plan Absent | Indication Tamoxifen | Indication Aromatase Inhibitors
Item
2. women with metastatic invasive breast cancer or locally advanced (without surgical project), for which treatment with tamoxifen or anti aromatase
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C3495949 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C3146298 (UMLS CUI [5,1])
C0039286 (UMLS CUI [5,2])
C3146298 (UMLS CUI [6,1])
C0593802 (UMLS CUI [6,2])
In addition to LH-RH Agonist | LH-RH Agonist Absent
Item
+/- lh-rh agonist, is indicated (anti-aromatase prescribed for menopausal womens; tamoxifen prescribed for both menopausal, pre menopausal or not menopausal womens).
boolean
C0332287 (UMLS CUI [1,1])
C1518041 (UMLS CUI [1,2])
C1518041 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Tumor Hormone Expression Estrogen Receptor | Tumor Hormone Expression Progesterone Receptor | Tumor Cell Percentage Immunohistochemistry
Item
3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (>= 10% of tumor cells by ihc technique).
boolean
C0027651 (UMLS CUI [1,1])
C0019932 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C0034804 (UMLS CUI [1,4])
C0027651 (UMLS CUI [2,1])
C0019932 (UMLS CUI [2,2])
C0017262 (UMLS CUI [2,3])
C0034833 (UMLS CUI [2,4])
C0597032 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
Neoplasm HER2 Negative
Item
cancer her2 negative.
boolean
C0027651 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
Evaluable Disease | Measurable Disease | Non-Measurable Lesion
Item
4. evaluable disease (measurable according recist criteria or not)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
C1334988 (UMLS CUI [3])
Hormone Therapy Adjuvant To be stopped
Item
5. any previous adjuvant hormone therapy should be discontinued for at least 21 days.
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,3])
Chemotherapy Quantity Neoplasm Metastasis
Item
6. one or two prior metastatic lines of chemotherapy are allowed
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
WHO performance status scale
Item
7. general status who 0-2
boolean
C1298650 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
8. the women of childbearing age must use an effective contraception for the duration of the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
9. informed consent obtained and signed before any specific study procedure
boolean
C0021430 (UMLS CUI [1])
Patient Member National Health Insurance
Item
10. patient member in a national insurance scheme
boolean
C0030705 (UMLS CUI [1,1])
C0680022 (UMLS CUI [1,2])
C0027452 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Pre-existing | Lacking Discontinuation Hormone Therapy Adjuvant
Item
1. patient already treated with hormone therapy or not having stopped the previous adjuvant hormone therapy for at least 21 days.
boolean
C0279025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
C1522673 (UMLS CUI [2,4])
Prescription Chemotherapy Breast Carcinoma | Prescription Targeted Therapy Breast Carcinoma | Exception Hormone Therapy
Item
2. prescription of chemotherapy and / or other targeted therapy (other than hormone therapy) for the treatment of the breast cancer
boolean
C0033080 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0033080 (UMLS CUI [2,1])
C2985566 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Hormone Therapy Secondary malignant neoplasm of female breast | Hormone Therapy Locally advanced breast cancer
Item
3. any previous hormone therapy for metastatic or locally advanced (without surgical project) breast cancer
boolean
C0279025 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C3495949 (UMLS CUI [2,2])
Hypercalcemia | Status pre- miRNA Dosage | Requirement Diphosphonates
Item
4. known hypercalcaemia before mirna dosage at t=0 requiring immediate biphosphonate therapy
boolean
C0020437 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C1101610 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0012544 (UMLS CUI [3,2])
Other medical condition Study Subject Participation Status Inappropriate | Mental condition Study Subject Participation Status Inappropriate | Laboratory test result abnormal Severe Study Subject Participation Status Inappropriate | Laboratory test result abnormal chronic Study Subject Participation Status Inappropriate
Item
5. any other medical or psychiatric condition or severe or chronic laboratory abnormality making the the inclusion of the patient in the study inappropriate in the opinion of the investigator.
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
C0438215 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C1548788 (UMLS CUI [4,4])
Protocol Compliance Unable
Item
6. patient unable to follow procedures, visits, examinations described in the study.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
7. pregnant women or nursing mothers will not participate in the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patients Guardianship
Item
8. patients under legal guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
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