ID

38009

Beschreibung

Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01446185

Link

https://clinicaltrials.gov/show/NCT01446185

Stichworte

Versionen (1)
  1. 08.09.19 08.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01446185

Englisch

Eligibility Breast Cancer NCT01446185

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients > 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. pre- or post- menopausal women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery, with a maximum of 4 weeks between surgery and the 2nd therapeutic decision with oncotype dx.
Beschreibung

Premenopausal state | Postmenopausal state | Breast adenocarcinoma | Operative Surgical Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0858252
UMLS CUI [4]
C0543467
3. hr positive (at least er+) breast cancer patients (defined by a threshold of 10% of the cells ihc + without n- or pn1(mi), her2 - (ihc0, 1, 2+ or fish -)
Beschreibung

Breast Carcinoma Hormone Receptor Positive | Oestrogen receptor positive breast cancer | Cells Positive Percentage Immunohistochemistry | TNM Breast tumor staging | Breast Carcinoma HER2 Negative | Immunohistochemistry | Fluorescent in Situ Hybridization Negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0019929
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C2938924
UMLS CUI [3,1]
C0007634
UMLS CUI [3,2]
C1514241
UMLS CUI [3,3]
C0439165
UMLS CUI [3,4]
C0021044
UMLS CUI [4]
C0474926
UMLS CUI [5,1]
C0678222
UMLS CUI [5,2]
C2348908
UMLS CUI [6]
C0021044
UMLS CUI [7,1]
C0162789
UMLS CUI [7,2]
C1513916
4. patients must be eligible to receive adjuvant chemotherapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity.
Beschreibung

Patients Eligible Adjuvant Chemotherapy | Karnofsky Performance Status Good | Medical contraindication Hematologic Absent | Medical contraindication cardiac Absent | Medical contraindication Hepatic Absent | Comorbidity Limiting Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0085533
UMLS CUI [2,1]
C0206065
UMLS CUI [2,2]
C0205170
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0205488
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0018787
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0205054
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0332197
5. patients must have given a written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. t3 or t4, hr-, n+ (except pn1 (mi) (sn), her2+ (ihc 3+ or fish+) patients.
Beschreibung

TNM Breast tumor staging | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | Immunohistochemistry | FISH Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0019929
UMLS CUI [2,3]
C1513916
UMLS CUI [3]
C1960398
UMLS CUI [4]
C0021044
UMLS CUI [5,1]
C0162789
UMLS CUI [5,2]
C1514241
2. metastatic patients.
Beschreibung

Patients metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522484
3. patients who cannot give an informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
4. patients who cannot receive chemotherapy.
Beschreibung

Chemotherapy Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
5. patient who participated in another clinical trial and is still in the exclusion period of any other trial.
Beschreibung

Study Subject Participation Status | Exclusion Period Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0008976
6. mentally disabled patient who has no legal responsibility for herself.
Beschreibung

Mental handicap | Legal responsibility Self Lacking

Datentyp

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0162399
UMLS CUI [2,2]
C0036588
UMLS CUI [2,3]
C0332268
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Ähnliche Modelle

Eligibility Breast Cancer NCT01446185

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients > 18 years old.
boolean
C0001779 (UMLS CUI [1])
Premenopausal state | Postmenopausal state | Breast adenocarcinoma | Operative Surgical Procedure
Item
2. pre- or post- menopausal women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery, with a maximum of 4 weeks between surgery and the 2nd therapeutic decision with oncotype dx.
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0858252 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Breast Carcinoma Hormone Receptor Positive | Oestrogen receptor positive breast cancer | Cells Positive Percentage Immunohistochemistry | TNM Breast tumor staging | Breast Carcinoma HER2 Negative | Immunohistochemistry | Fluorescent in Situ Hybridization Negative
Item
3. hr positive (at least er+) breast cancer patients (defined by a threshold of 10% of the cells ihc + without n- or pn1(mi), her2 - (ihc0, 1, 2+ or fish -)
boolean
C0678222 (UMLS CUI [1,1])
C0019929 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C2938924 (UMLS CUI [2])
C0007634 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0439165 (UMLS CUI [3,3])
C0021044 (UMLS CUI [3,4])
C0474926 (UMLS CUI [4])
C0678222 (UMLS CUI [5,1])
C2348908 (UMLS CUI [5,2])
C0021044 (UMLS CUI [6])
C0162789 (UMLS CUI [7,1])
C1513916 (UMLS CUI [7,2])
Patients Eligible Adjuvant Chemotherapy | Karnofsky Performance Status Good | Medical contraindication Hematologic Absent | Medical contraindication cardiac Absent | Medical contraindication Hepatic Absent | Comorbidity Limiting Absent
Item
4. patients must be eligible to receive adjuvant chemotherapy as defined by a good karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
C0206065 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0205488 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C0018787 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1301624 (UMLS CUI [5,1])
C0205054 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0009488 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Informed Consent
Item
5. patients must have given a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
TNM Breast tumor staging | Breast Carcinoma Hormone Receptor Negative | HER2-positive carcinoma of breast | Immunohistochemistry | FISH Positive
Item
1. t3 or t4, hr-, n+ (except pn1 (mi) (sn), her2+ (ihc 3+ or fish+) patients.
boolean
C0474926 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0019929 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C1960398 (UMLS CUI [3])
C0021044 (UMLS CUI [4])
C0162789 (UMLS CUI [5,1])
C1514241 (UMLS CUI [5,2])
Patients metastatic
Item
2. metastatic patients.
boolean
C0030705 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Informed Consent Unable
Item
3. patients who cannot give an informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Chemotherapy Receive Unable
Item
4. patients who cannot receive chemotherapy.
boolean
C0392920 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status | Exclusion Period Clinical Trial
Item
5. patient who participated in another clinical trial and is still in the exclusion period of any other trial.
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Mental handicap | Legal responsibility Self Lacking
Item
6. mentally disabled patient who has no legal responsibility for herself.
boolean
C1306341 (UMLS CUI [1])
C0162399 (UMLS CUI [2,1])
C0036588 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
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