ID

38140

Beskrivning

Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01926964

Länk

https://clinicaltrials.gov/show/NCT01926964

Nyckelord

Versioner (1)
  1. 2019-09-21 2019-09-21 -
Rättsinnehavare

See clinicaltrials.gov

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21 september 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01926964

Engelsk

Eligibility Breast Cancer NCT01926964

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients screening criteria
Beskrivning

Screening criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710032
UMLS CUI [1,2]
C0243161
1. ≥ 18 years old female patients.
Beskrivning

Age | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
2. resected primary breast cancer (r0 resection).
Beskrivning

Excision Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C0678222
3. er-positive breast cancer (defined as at least 10% er-positive malignant cells).
Beskrivning

Oestrogen receptor positive breast cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C2938924
4. her2 negativity by ihc (0 or 1+) or by fish (negative if ratio is ≤ 2.0).
Beskrivning

HER2 Negative Immunohistochemistry | HER2 Negative FISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348908
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C2348908
UMLS CUI [2,2]
C0162789
5. pn0 or pn1a (1-3 positive nodes) by sentinel procedure or axillary dissection.
Beskrivning

TNM Breast tumor staging | Number of Lymph Nodes Positive | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1]
C0474926
UMLS CUI [2]
C4086646
UMLS CUI [3]
C0796693
UMLS CUI [4]
C0193867
all patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list.
Beskrivning

Screening criteria Fulfill | Enrollment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710032
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C1516879
patients inclusion criteria for baseline data collection
Beskrivning

Inclusion criteria Baseline Data Collection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0010995
1. signed informed consent form for participation to the baseline data collection.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
in addition, the following information must be available from the pathology report:
Beskrivning

Availability of Information Pathology report

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C0807321
2. estimation of the pathologic maximum tumor diameter (in mm).
Beskrivning

Tumor Diameter Maximum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0806909
3. results of er positive tumor cells (in %) and of pgr positive tumor cells (in %) of the invasive component.
Beskrivning

Neoplastic Cell Estrogen receptor positive Percentage | Neoplastic Cell Progesterone receptor positive Percentage | Component Invasive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C0279759
UMLS CUI [2,3]
C0439165
UMLS CUI [3,1]
C1705248
UMLS CUI [3,2]
C0205281
4. proliferation rate by ki-67 staining (mib-1 antibody) in %.
Beskrivning

Proliferation Rate Percentage Ki67 Staining Method | MIB-1 antibody

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514485
UMLS CUI [1,2]
C0871208
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C4055454
UMLS CUI [2]
C1138401
5. result of modified bloom-richardson-elston (bre) grading (grade 1, 2 or 3).
Beskrivning

Modified Bloom-Richardson-Elston grading system

Datatyp

boolean

Alias
UMLS CUI [1]
C1527124
patients eligibility criteria for participation to the study inclusion criteria
Beskrivning

Eligibility Criteria | Participation Clinical Trial Inclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C1516637
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C1512693
1. signed informed consent form for participation to the study sakk 26/10.
Beskrivning

Informed Consent | Participation Clinical Trial Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
2. the patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).
Beskrivning

Patients Appropriate Adjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0085533
3. invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 h&e stained slides, thickness of 5 µm).
Beskrivning

Invasive carcinoma of breast | Availability of Tumor tissue sample | Section Quantity | Unstained Specimen | Hematoxylin and eosin stain method

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0475358
UMLS CUI [3,1]
C0700320
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C1883469
UMLS CUI [5]
C0523207
4. performance status: 0 or 1.
Beskrivning

Performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1518965
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
2. bilateral invasive breast cancer
Beskrivning

Invasive carcinoma of breast Bilateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
3. ct4 and pt4 tumors.
Beskrivning

TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0474926
4. patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
Beskrivning

Mental disorder Interferes with Study Subject Participation Status | Disease Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
5. known metastatic breast cancer (m1).
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
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Similar models

Eligibility Breast Cancer NCT01926964

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Screening criteria
Item
patients screening criteria
boolean
C1710032 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Age | Gender
Item
1. ≥ 18 years old female patients.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Excision Breast Carcinoma
Item
2. resected primary breast cancer (r0 resection).
boolean
C0728940 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Oestrogen receptor positive breast cancer
Item
3. er-positive breast cancer (defined as at least 10% er-positive malignant cells).
boolean
C2938924 (UMLS CUI [1])
HER2 Negative Immunohistochemistry | HER2 Negative FISH
Item
4. her2 negativity by ihc (0 or 1+) or by fish (negative if ratio is ≤ 2.0).
boolean
C2348908 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2348908 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
TNM Breast tumor staging | Number of Lymph Nodes Positive | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
5. pn0 or pn1a (1-3 positive nodes) by sentinel procedure or axillary dissection.
boolean
C0474926 (UMLS CUI [1])
C4086646 (UMLS CUI [2])
C0796693 (UMLS CUI [3])
C0193867 (UMLS CUI [4])
Screening criteria Fulfill | Enrollment
Item
all patients matching the screening criteria should be recorded consecutively in the patient screening and enrollment list.
boolean
C1710032 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1516879 (UMLS CUI [2])
Inclusion criteria Baseline Data Collection
Item
patients inclusion criteria for baseline data collection
boolean
C1512693 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0010995 (UMLS CUI [1,3])
Informed Consent
Item
1. signed informed consent form for participation to the baseline data collection.
boolean
C0021430 (UMLS CUI [1])
Availability of Information Pathology report
Item
in addition, the following information must be available from the pathology report:
boolean
C0470187 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0807321 (UMLS CUI [1,3])
Tumor Diameter Maximum
Item
2. estimation of the pathologic maximum tumor diameter (in mm).
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Neoplastic Cell Estrogen receptor positive Percentage | Neoplastic Cell Progesterone receptor positive Percentage | Component Invasive
Item
3. results of er positive tumor cells (in %) and of pgr positive tumor cells (in %) of the invasive component.
boolean
C0597032 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0597032 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C1705248 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
Proliferation Rate Percentage Ki67 Staining Method | MIB-1 antibody
Item
4. proliferation rate by ki-67 staining (mib-1 antibody) in %.
boolean
C1514485 (UMLS CUI [1,1])
C0871208 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C4055454 (UMLS CUI [1,4])
C1138401 (UMLS CUI [2])
Modified Bloom-Richardson-Elston grading system
Item
5. result of modified bloom-richardson-elston (bre) grading (grade 1, 2 or 3).
boolean
C1527124 (UMLS CUI [1])
Eligibility Criteria | Participation Clinical Trial Inclusion criteria
Item
patients eligibility criteria for participation to the study inclusion criteria
boolean
C1516637 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
Informed Consent | Participation Clinical Trial Specified
Item
1. signed informed consent form for participation to the study sakk 26/10.
boolean
C0021430 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Patients Appropriate Adjuvant Chemotherapy
Item
2. the patient is considered suitable to receive adjuvant chemotherapy (ie no medical contraindications to chemotherapy).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
Invasive carcinoma of breast | Availability of Tumor tissue sample | Section Quantity | Unstained Specimen | Hematoxylin and eosin stain method
Item
3. invasive breast cancer tissue is available to prepare 39 sections (35 unstained + 4 h&e stained slides, thickness of 5 µm).
boolean
C0853879 (UMLS CUI [1])
C0470187 (UMLS CUI [2,1])
C0475358 (UMLS CUI [2,2])
C0700320 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1883469 (UMLS CUI [4])
C0523207 (UMLS CUI [5])
Performance status
Item
4. performance status: 0 or 1.
boolean
C1518965 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
1. pregnancy
boolean
C0032961 (UMLS CUI [1])
Invasive carcinoma of breast Bilateral
Item
2. bilateral invasive breast cancer
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
TNM Breast tumor staging
Item
3. ct4 and pt4 tumors.
boolean
C0474926 (UMLS CUI [1])
Mental disorder Interferes with Study Subject Participation Status | Disease Interferes with Study Subject Participation Status
Item
4. patient with a current psychiatric or medical diagnosis that would interfere with her ability to participate in this study.
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
Secondary malignant neoplasm of female breast
Item
5. known metastatic breast cancer (m1).
boolean
C0346993 (UMLS CUI [1])
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