ID

37995

Beskrivning

Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01400438

Länk

https://clinicaltrials.gov/show/NCT01400438

Nyckelord

Versioner (1)
  1. 2019-09-05 2019-09-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01400438

Engelsk

Eligibility Breast Cancer NCT01400438

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged over 18
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
invasive breast carcinoma confirmed histologically
Beskrivning

Invasive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0853879
non-metastatic cancer
Beskrivning

Non-Metastatic Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C1334991
surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
Beskrivning

Operative Surgical Procedure Primary tumor | Mastectomy | Segmental Mastectomy | Medical Audit Axillary | Sentinel Lymph Node Dissection | Excision of axillary lymph nodes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0024885
UMLS CUI [4,1]
C0025072
UMLS CUI [4,2]
C0004454
UMLS CUI [5,1]
C1522495
UMLS CUI [5,2]
C0012737
UMLS CUI [6]
C0193867
patient should receive their last course of adjuvant chemotherapy (3 fec and 3 taxotere)
Beskrivning

Adjuvant Chemotherapy Course Last | FEC Regimen | Taxotere

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1517741
UMLS CUI [2]
C0060133
UMLS CUI [3]
C0699967
patients not receiving the third course of taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of taxotere
Beskrivning

Taxotere Lacking Due to Toxicity | Chemotherapy Course

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0699967
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0600688
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C0750729
for the group herceptin ®: her2 overexpression without contraindication to treatment administration
Beskrivning

Herceptin Group | HER2 Protein Overexpression | Medical contraindication Absent Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C0441833
UMLS CUI [2]
C1515560
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0087111
for the control group: no indication for herceptin ®
Beskrivning

Control Group | Indication Absent Herceptin

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0338204
radiation therapy and / or adjuvant hormonal therapy allowed
Beskrivning

Therapeutic radiology procedure allowed | Hormone Therapy Adjuvant allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
UMLS CUI [2,3]
C0683607
free and informed consent signed
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
women under 18 or over 60 years
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histology other than adenocarcinoma
Beskrivning

Histology | Adenocarcinoma Excluded

Datatyp

boolean

Alias
UMLS CUI [1]
C0344441
UMLS CUI [2,1]
C0001418
UMLS CUI [2,2]
C0332196
metastatic breast cancer
Beskrivning

Secondary malignant neoplasm of female breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
chemotherapy neoadjuvant
Beskrivning

Neoadjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
surgery of the primary tumor unrealized
Beskrivning

Operative Surgical Procedure Primary tumor Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C0332268
lack of adjuvant chemotherapy with taxotere 3 fec and 3
Beskrivning

Adjuvant Chemotherapy Lacking | Taxotere Lacking | FEC Regimen Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0699967
UMLS CUI [2,2]
C0332268
UMLS CUI [3,1]
C0060133
UMLS CUI [3,2]
C0332268
patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma Treated Cured | Exception Cervix carcinoma Treated Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C1880198
patient under guardianship or unable to give informed consent,
Beskrivning

Patient Guardianship | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patient unable to undergo a medical for geographical, social or psychopathological
Beskrivning

Medical procedure Receive Unable | Etiology Geographic Factors | Etiology Social factor | Etiology Psychopathologic disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0017444
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0337460
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0544667
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Similar models

Eligibility Breast Cancer NCT01400438

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged over 18
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast
Item
invasive breast carcinoma confirmed histologically
boolean
C0853879 (UMLS CUI [1])
Non-Metastatic Neoplasm
Item
non-metastatic cancer
boolean
C1334991 (UMLS CUI [1])
Operative Surgical Procedure Primary tumor | Mastectomy | Segmental Mastectomy | Medical Audit Axillary | Sentinel Lymph Node Dissection | Excision of axillary lymph nodes
Item
surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
C0025072 (UMLS CUI [4,1])
C0004454 (UMLS CUI [4,2])
C1522495 (UMLS CUI [5,1])
C0012737 (UMLS CUI [5,2])
C0193867 (UMLS CUI [6])
Adjuvant Chemotherapy Course Last | FEC Regimen | Taxotere
Item
patient should receive their last course of adjuvant chemotherapy (3 fec and 3 taxotere)
boolean
C0085533 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0060133 (UMLS CUI [2])
C0699967 (UMLS CUI [3])
Taxotere Lacking Due to Toxicity | Chemotherapy Course
Item
patients not receiving the third course of taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of taxotere
boolean
C0699967 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C3665472 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
Herceptin Group | HER2 Protein Overexpression | Medical contraindication Absent Therapeutic procedure
Item
for the group herceptin ®: her2 overexpression without contraindication to treatment administration
boolean
C0338204 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C1515560 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Control Group | Indication Absent Herceptin
Item
for the control group: no indication for herceptin ®
boolean
C0009932 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0338204 (UMLS CUI [2,3])
Therapeutic radiology procedure allowed | Hormone Therapy Adjuvant allowed
Item
radiation therapy and / or adjuvant hormonal therapy allowed
boolean
C1522449 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Informed Consent
Item
free and informed consent signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Gender | Age
Item
women under 18 or over 60 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Histology | Adenocarcinoma Excluded
Item
histology other than adenocarcinoma
boolean
C0344441 (UMLS CUI [1])
C0001418 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Secondary malignant neoplasm of female breast
Item
metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Neoadjuvant Chemotherapy
Item
chemotherapy neoadjuvant
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
Operative Surgical Procedure Primary tumor Lacking
Item
surgery of the primary tumor unrealized
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Adjuvant Chemotherapy Lacking | Taxotere Lacking | FEC Regimen Lacking
Item
lack of adjuvant chemotherapy with taxotere 3 fec and 3
boolean
C0085533 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0699967 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0060133 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated Cured | Exception Cervix carcinoma Treated Cured
Item
patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1880198 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1880198 (UMLS CUI [3,4])
Patient Guardianship | Informed Consent Unable
Item
patient under guardianship or unable to give informed consent,
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical procedure Receive Unable | Etiology Geographic Factors | Etiology Social factor | Etiology Psychopathologic disorder
Item
patient unable to undergo a medical for geographical, social or psychopathological
boolean
C0199171 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0017444 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0337460 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0544667 (UMLS CUI [4,2])
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