ID

38168

Beskrivning

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay; ODM derived from: https://clinicaltrials.gov/show/NCT01899079

Länk

https://clinicaltrials.gov/show/NCT01899079

Nyckelord

Versioner (1)
  1. 2019-09-24 2019-09-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 september 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.

Tillbaka till modellkommentarer
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 Breast Cancer NCT01899079

Engelsk

Eligibility Breast Cancer NCT01899079

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
Beskrivning

Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2363430
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1521996
UMLS CUI [2,3]
C0678034
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0279754
UMLS CUI [3,3]
C2348908
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
Beskrivning

Estrogen Receptor Status Immunohistochemistry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516974
UMLS CUI [1,2]
C0021044
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
Beskrivning

HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1512413
UMLS CUI [2,2]
C0162789
postmenopausal females, which is defined as:
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
1. natural amenorrhea > 12 months, regardless of age
Beskrivning

Amenorrhea Natural Duration | Independent of Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0205296
UMLS CUI [1,3]
C0449238
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
Beskrivning

Bilateral oophorectomy | Independent of Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0001779
3. radiological castration with amenorrhea > 3 months, regardless of age
Beskrivning

Castration Radiologic | Amenorrhea Duration | Independent of Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007344
UMLS CUI [1,2]
C0205483
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C0332291
UMLS CUI [3,2]
C0001779
4. hysterectomy and postmenopausal blood levels
Beskrivning

Hysterectomy | Blood Level Postmenopausal

Datatyp

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2,1]
C0005767
UMLS CUI [2,2]
C0441889
UMLS CUI [2,3]
C0232970
able to give consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
eligible for treatment of breast cancer with adjuvant chemotherapy
Beskrivning

Eligibility Adjuvant Chemotherapy Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0085533
UMLS CUI [1,3]
C0678222
ecog performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
tumor size t3-t4
Beskrivning

Tumor size TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0474926
non-invasive breast cancer (e.g., paget's disease, dcis)
Beskrivning

Breast Carcinoma Non-invasive | Paget Disease | DCIS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205303
UMLS CUI [2]
C1368019
UMLS CUI [3]
C0007124
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
Beskrivning

Cancer of lymph node TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948627
UMLS CUI [1,2]
C3258246
tumors that are estrogen-receptor negative or her2 positive
Beskrivning

Neoplasms Estrogen receptor negative | Neoplasms HER2 positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C2348909
have metastatic disease
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
unable to give informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
unable to complete patient reported outcome surveys
Beskrivning

Outcome Surveys Completion Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0038951
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
have contraindications for adjuvant chemotherapy
Beskrivning

Medical contraindication Adjuvant Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085533
age, performance status, significant comorbidities
Beskrivning

Age | Performance status | Comorbidity Significant

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1518965
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0750502
ecog performance status > 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01899079

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast Early stage TNM Breast tumor staging | Invasive carcinoma of breast Resected Negative Lymph Node | Invasive carcinoma of breast Estrogen receptor positive HER2 Negative
Item
resected node-negative, estrogen-receptor-positive, her2-negative early- stage invasive breast cancer (t1-t2, n0, pn0 (i+), pn0 (mol+), m0)
boolean
C0853879 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C1521996 (UMLS CUI [2,2])
C0678034 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C2348908 (UMLS CUI [3,3])
Estrogen Receptor Status Immunohistochemistry
Item
1. estrogen receptor status will be evaluated by immunohistochemistry (ihc)and more than 1% of stained tumor cells will be considered positive.
boolean
C1516974 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 Status Immunohistochemistry | HER2 Status Fluorescent in Situ Hybridization
Item
2. her2 status will be evaluated by (ihc; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
boolean
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1512413 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Postmenopausal state
Item
postmenopausal females, which is defined as:
boolean
C0232970 (UMLS CUI [1])
Amenorrhea Natural Duration | Independent of Age
Item
1. natural amenorrhea > 12 months, regardless of age
boolean
C0002453 (UMLS CUI [1,1])
C0205296 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Bilateral oophorectomy | Independent of Age
Item
2. bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
boolean
C0278321 (UMLS CUI [1])
C0332291 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
Castration Radiologic | Amenorrhea Duration | Independent of Age
Item
3. radiological castration with amenorrhea > 3 months, regardless of age
boolean
C0007344 (UMLS CUI [1,1])
C0205483 (UMLS CUI [1,2])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332291 (UMLS CUI [3,1])
C0001779 (UMLS CUI [3,2])
Hysterectomy | Blood Level Postmenopausal
Item
4. hysterectomy and postmenopausal blood levels
boolean
C0020699 (UMLS CUI [1])
C0005767 (UMLS CUI [2,1])
C0441889 (UMLS CUI [2,2])
C0232970 (UMLS CUI [2,3])
Informed Consent
Item
able to give consent
boolean
C0021430 (UMLS CUI [1])
Eligibility Adjuvant Chemotherapy Breast Carcinoma
Item
eligible for treatment of breast cancer with adjuvant chemotherapy
boolean
C1548635 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Tumor size TNM Breast tumor staging
Item
tumor size t3-t4
boolean
C0475440 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Breast Carcinoma Non-invasive | Paget Disease | DCIS
Item
non-invasive breast cancer (e.g., paget's disease, dcis)
boolean
C0678222 (UMLS CUI [1,1])
C0205303 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Cancer of lymph node TNM clinical staging
Item
tumors with nodes that are not n0, pn0 (i+), or pn0 (mol+)
boolean
C0948627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Neoplasms Estrogen receptor negative | Neoplasms HER2 positive
Item
tumors that are estrogen-receptor negative or her2 positive
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Neoplasm Metastasis
Item
have metastatic disease
boolean
C0027627 (UMLS CUI [1])
Informed Consent Unable
Item
unable to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Outcome Surveys Completion Unable
Item
unable to complete patient reported outcome surveys
boolean
C1274040 (UMLS CUI [1,1])
C0038951 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Medical contraindication Adjuvant Chemotherapy
Item
have contraindications for adjuvant chemotherapy
boolean
C1301624 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Age | Performance status | Comorbidity Significant
Item
age, performance status, significant comorbidities
boolean
C0001779 (UMLS CUI [1])
C1518965 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
ECOG performance status
Item
ecog performance status > 1
boolean
C1520224 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

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

Fält markerade med * är obligatoriska.

Hjälp

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