ID

39122

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02095743

Nyckelord

  1. 2019-12-02 2019-12-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 december 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Early Stage Breast Carcinoma NCT02095743

Eligibility Early Stage Breast Carcinoma NCT02095743

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women age > 18
Beskrivning

Gender | Age

Datatyp

boolean

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

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
no her2 overexpression
Beskrivning

HER2 Protein Overexpression Absent

Datatyp

boolean

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

Operative Surgical Procedure Curative | Distant metastasis Absent

Datatyp

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).
Beskrivning

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

Datatyp

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
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
bilateral axillary node dissection
Beskrivning

Excision of axillary lymph nodes Bilateral

Datatyp

boolean

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

Therapeutic radiology procedure Upper chest Bilateral

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Thrombosis Upper body

Datatyp

boolean

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

Anticoagulation Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0003281
tracheotomy
Beskrivning

Tracheotomy

Datatyp

boolean

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

Treatment Bacteremia

Datatyp

boolean

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

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

Datatyp

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
Beskrivning

Kidney Failure | Creatinine clearance measurement

Datatyp

boolean

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

Study Subject Participation Status | Involvement Clinical Trial

Datatyp

boolean

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

Medical contraindication FEC Regimen | Medical contraindication Taxotere

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

Patient Guardianship

Datatyp

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
Beskrivning

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

Datatyp

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

Similar models

Eligibility Early Stage Breast Carcinoma NCT02095743

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial