ID

39122

Description

Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02095743

Link

https://clinicaltrials.gov/show/NCT02095743

Keywords

Versions (1)
  1. 12/2/19 12/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Early Stage Breast Carcinoma NCT02095743

English

Eligibility Early Stage Breast Carcinoma NCT02095743

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women age > 18
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
documented breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
no her2 overexpression
Description

HER2 Protein Overexpression Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0332197
patients operated with curative intent (no distant metastasis at diagnosis)
Description

Operative Surgical Procedure Curative | Distant metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1276305
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
patients undergoing an adjuvant chemotherapy consisting of 3 courses of fec 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of taxotere, or 6fec100 (according to chb refencial for localised breast cancer treatment).
Description

Chemotherapy, Adjuvant | Chemotherapy cycle Quantity FEC Regimen | Chemotherapy cycle Quantity Taxotere

Data type

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0060133
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0699967
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral axillary node dissection
Description

Excision of axillary lymph nodes Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0193867
UMLS CUI [1,2]
C0238767
history of bilateral upper thoracic irradiation
Description

Therapeutic radiology procedure Upper chest Bilateral

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0446469
UMLS CUI [1,3]
C0238767
cutaneous disease (eczema, scleroderma, infection…) at catheter insertion site (arm or upper thorax)
Description

Dermatologic disorder Catheter insertion Site | Dermatologic disorder Arm | Dermatologic disorder Upper chest | Eczema | Scleroderma | Skin Diseases, Infectious

Data type

boolean

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0007430
UMLS CUI [1,3]
C1515974
UMLS CUI [2,1]
C0037274
UMLS CUI [2,2]
C1140618
UMLS CUI [3,1]
C0037274
UMLS CUI [3,2]
C0446469
UMLS CUI [4]
C0013595
UMLS CUI [5]
C0011644
UMLS CUI [6]
C0037278
recent thrombosis of the upper body
Description

Thrombosis Upper body

Data type

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C1285082
therapeutic anticoagulation
Description

Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003281
tracheotomy
Description

Tracheotomy

Data type

boolean

Alias
UMLS CUI [1]
C0040591
treatment for bacteriemia in process
Description

Treatment Bacteremia

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0004610
altered hemostasis: inr > 1.5 ; aptt > 1.5 , platelets < 60 g/l
Description

Hemostasis altered | INR | Activated Partial Thromboplastin Time measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0019116
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C0525032
UMLS CUI [3]
C0030605
UMLS CUI [4]
C0032181
renal failure with creatinine clearance < 60ml/min
Description

Kidney Failure | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2]
C0373595
involvement in another trial
Description

Study Subject Participation Status | Involvement Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0008976
contraindication to chemotherapy by fec 100 or taxotere
Description

Medical contraindication FEC Regimen | Medical contraindication Taxotere

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0060133
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0699967
pregnancy or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
protected major patient (under guardianship).
Description

Patient Guardianship

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0870627
psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french
Description

Psychosocial problem | Mental disorders Decompensated | Social Security Coverage Lacking | Lacking Able to speak French language

Data type

boolean

Alias
UMLS CUI [1]
C0740697
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205434
UMLS CUI [3,1]
C0037435
UMLS CUI [3,2]
C1551362
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C0332268
UMLS CUI [4,2]
C0564215
UMLS CUI [4,3]
C0376246
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Similar models

Eligibility Early Stage Breast Carcinoma NCT02095743

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women age > 18
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
documented breast cancer
boolean
C0678222 (UMLS CUI [1])
HER2 Protein Overexpression Absent
Item
no her2 overexpression
boolean
C1515560 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Operative Surgical Procedure Curative | Distant metastasis Absent
Item
patients operated with curative intent (no distant metastasis at diagnosis)
boolean
C0543467 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Chemotherapy, Adjuvant | Chemotherapy cycle Quantity FEC Regimen | Chemotherapy cycle Quantity Taxotere
Item
patients undergoing an adjuvant chemotherapy consisting of 3 courses of fec 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of taxotere, or 6fec100 (according to chb refencial for localised breast cancer treatment).
boolean
C0085533 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0060133 (UMLS CUI [2,3])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0699967 (UMLS CUI [3,3])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Excision of axillary lymph nodes Bilateral
Item
bilateral axillary node dissection
boolean
C0193867 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Therapeutic radiology procedure Upper chest Bilateral
Item
history of bilateral upper thoracic irradiation
boolean
C1522449 (UMLS CUI [1,1])
C0446469 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Dermatologic disorder Catheter insertion Site | Dermatologic disorder Arm | Dermatologic disorder Upper chest | Eczema | Scleroderma | Skin Diseases, Infectious
Item
cutaneous disease (eczema, scleroderma, infection…) at catheter insertion site (arm or upper thorax)
boolean
C0037274 (UMLS CUI [1,1])
C0007430 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0037274 (UMLS CUI [2,1])
C1140618 (UMLS CUI [2,2])
C0037274 (UMLS CUI [3,1])
C0446469 (UMLS CUI [3,2])
C0013595 (UMLS CUI [4])
C0011644 (UMLS CUI [5])
C0037278 (UMLS CUI [6])
Thrombosis Upper body
Item
recent thrombosis of the upper body
boolean
C0040053 (UMLS CUI [1,1])
C1285082 (UMLS CUI [1,2])
Anticoagulation Therapy
Item
therapeutic anticoagulation
boolean
C0003281 (UMLS CUI [1])
Tracheotomy
Item
tracheotomy
boolean
C0040591 (UMLS CUI [1])
Treatment Bacteremia
Item
treatment for bacteriemia in process
boolean
C0087111 (UMLS CUI [1,1])
C0004610 (UMLS CUI [1,2])
Hemostasis altered | INR | Activated Partial Thromboplastin Time measurement | Platelet Count measurement
Item
altered hemostasis: inr > 1.5 ; aptt > 1.5 , platelets < 60 g/l
boolean
C0019116 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Kidney Failure | Creatinine clearance measurement
Item
renal failure with creatinine clearance < 60ml/min
boolean
C0035078 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Study Subject Participation Status | Involvement Clinical Trial
Item
involvement in another trial
boolean
C2348568 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Medical contraindication FEC Regimen | Medical contraindication Taxotere
Item
contraindication to chemotherapy by fec 100 or taxotere
boolean
C1301624 (UMLS CUI [1,1])
C0060133 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0699967 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Patient Guardianship
Item
protected major patient (under guardianship).
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])
Psychosocial problem | Mental disorders Decompensated | Social Security Coverage Lacking | Lacking Able to speak French language
Item
psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french
boolean
C0740697 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0205434 (UMLS CUI [2,2])
C0037435 (UMLS CUI [3,1])
C1551362 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0332268 (UMLS CUI [4,1])
C0564215 (UMLS CUI [4,2])
C0376246 (UMLS CUI [4,3])
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