ID

38044

Beschreibung

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not; ODM derived from: https://clinicaltrials.gov/show/NCT01553903

Link

https://clinicaltrials.gov/show/NCT01553903

Stichworte

Versionen (2)
  1. 11.09.19 11.09.19 -
  2. 12.09.19 12.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. September 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Breast Cancer NCT01553903

Englisch

Eligibility Breast Cancer NCT01553903

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Gender | Age | Menopause | Menopause Absent

Datentyp

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 invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
Beschreibung

Gender | Invasive carcinoma of breast metastatic | Invasive carcinoma of breast | Tamoxifen | Aromatase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
UMLS CUI [3]
C0853879
UMLS CUI [4]
C0039286
UMLS CUI [5]
C0593802
3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (≥ 10% of tumor cells in technical hic).
Beschreibung

Estrogen Receptor expression | Progesterone Receptor expression | Tumor Cells Percentage Immunohistochemistry

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C1171362
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C1171362
UMLS CUI [3,1]
C0597032
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0021044
4. any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
Beschreibung

Hormone Therapy To be stopped

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1272691
5. who ≤ 2.
Beschreibung

WHO performance status scale

Datentyp

boolean

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

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
7. informed consent obtained and signed before any specific procedure in the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
8. patient member in a national insurance scheme.
Beschreibung

Patient Member National Health Insurance

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient with breast cancer her2 positive (ihc and / or fish-cish)
Beschreibung

HER2-positive carcinoma of breast Immunohistochemistry | HER2-positive carcinoma of breast FISH | HER2-positive carcinoma of breast CISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C0162789
UMLS CUI [3,1]
C1960398
UMLS CUI [3,2]
C1516514
2. patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
Beschreibung

Hormone Therapy Pre-existing | Discontinuation Hormone Therapy Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C1444662
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0332268
3. patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
4. any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
Beschreibung

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 Study Subject Participation Status Inappropriate | Laboratory test result abnormal chronic Study Subject Participation Status Inappropriate

Datentyp

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]
C2348568
UMLS CUI [4,3]
C1548788
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C0205191
UMLS CUI [5,3]
C2348568
UMLS CUI [5,4]
C1548788
5. patient unable to follow procedures, visits, examinations described in the study.
Beschreibung

Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
6. pregnant women or nursing mothers can not participate in the study.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. patients under legal guardianship.
Beschreibung

Patients Guardianship

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
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Ähnliche Modelle

Eligibility Breast Cancer NCT01553903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Menopause | Menopause Absent
Item
1. women of more than 18 years old (menopause 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 | Invasive carcinoma of breast | Tamoxifen | Aromatase Inhibitors
Item
2. women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
Estrogen Receptor expression | Progesterone Receptor expression | Tumor Cells Percentage Immunohistochemistry
Item
3. cancer hormone-expressing estrogen receptor (er) and / or progesterone receptor (pr) (≥ 10% of tumor cells in technical hic).
boolean
C0034804 (UMLS CUI [1,1])
C1171362 (UMLS CUI [1,2])
C0034833 (UMLS CUI [2,1])
C1171362 (UMLS CUI [2,2])
C0597032 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0021044 (UMLS CUI [3,3])
Hormone Therapy To be stopped
Item
4. any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
boolean
C0279025 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
WHO performance status scale
Item
5. who ≤ 2.
boolean
C1298650 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
6. women of childbearing age must use effective contraception for the duration of the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent
Item
7. informed consent obtained and signed before any specific procedure in the study.
boolean
C0021430 (UMLS CUI [1])
Patient Member National Health Insurance
Item
8. 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)
HER2-positive carcinoma of breast Immunohistochemistry | HER2-positive carcinoma of breast FISH | HER2-positive carcinoma of breast CISH
Item
1. patient with breast cancer her2 positive (ihc and / or fish-cish)
boolean
C1960398 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1960398 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C1960398 (UMLS CUI [3,1])
C1516514 (UMLS CUI [3,2])
Hormone Therapy Pre-existing | Discontinuation Hormone Therapy Lacking
Item
2. patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
boolean
C0279025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1444662 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Chemotherapy Required Breast Carcinoma | Targeted Therapy Required Breast Carcinoma | Exception Hormone Therapy
Item
3. patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
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 Study Subject Participation Status Inappropriate | Laboratory test result abnormal chronic Study Subject Participation Status Inappropriate
Item
4. any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making 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])
C2348568 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C1548788 (UMLS CUI [5,4])
Protocol Compliance Unable
Item
5. 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
6. pregnant women or nursing mothers can not participate in the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patients Guardianship
Item
7. patients under legal guardianship.
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
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