ID

34996

Beschrijving

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET; ODM derived from: https://clinicaltrials.gov/show/NCT02261389

Link

https://clinicaltrials.gov/show/NCT02261389

Trefwoorden

Versies (1)
  1. 07-02-19 07-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 februari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT02261389

Engels

Eligibility Breast Cancer NCT02261389

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female ≥18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed stage i-iii epithelial breast cancer.
Beschrijving

Breast Carcinoma epithelial TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0221908
UMLS CUI [1,3]
C0474926
adequate surgery of breast and axilla:
Beschrijving

Operation on breast | Axilla Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C3714726
UMLS CUI [2,1]
C0004454
UMLS CUI [2,2]
C0543467
1. patients must have undergone either a total mastectomy or breast conserving surgery
Beschrijving

Total mastectomy | Breast-Conserving Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0024886
UMLS CUI [2]
C0917927
2. surgical margins of the resected specimen must be histologically free of invasive tumor.
Beschrijving

Specimen Resected | Surgical margins Free of Invasive cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C1521996
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0677898
signed informed consent obtained prior to any study-specific procedures.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ).
Beschrijving

Breast Carcinoma epithelial TNM Breast tumor staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0221908
UMLS CUI [1,3]
C0474926
special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma)
Beschrijving

Histology High risk of Relapse | Histology Low Risk Relapse | Sarcoma | Carcinoma, Tubular

Datatype

boolean

Alias
UMLS CUI [1,1]
C4048239
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0035020
UMLS CUI [2,1]
C4048239
UMLS CUI [2,2]
C3538919
UMLS CUI [2,3]
C0035020
UMLS CUI [3]
C1261473
UMLS CUI [4]
C0205645
t1a and t1b tumors with all the following characteristics: g1-2 and n0 and re > 10%, rpg > 10% and her2 negative and ki67≤14%
Beschrijving

Malignant Neoplasms TNM Breast tumor staging | Estrogen Receptor Measurement | Progesterone Receptor Measurement | HER2 Negative | Ki67 Measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C3811131
UMLS CUI [3]
C3889640
UMLS CUI [4]
C2348908
UMLS CUI [5]
C4049944
evidence of distant metastases
Beschrijving

Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
patients participating to other clinical trials requiring follow-up not equal to standard
Beschrijving

Study Subject Participation Status | Requirement Follow-up Special

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0205555
previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage i uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
Beschrijving

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Uterine Cancer TNM clinical staging Treated

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0153567
UMLS CUI [4,3]
C3258246
UMLS CUI [4,4]
C1522326
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT02261389

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma epithelial TNM Breast tumor staging
Item
histologically confirmed stage i-iii epithelial breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Operation on breast | Axilla Operative Surgical Procedures
Item
adequate surgery of breast and axilla:
boolean
C3714726 (UMLS CUI [1])
C0004454 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Total mastectomy | Breast-Conserving Surgery
Item
1. patients must have undergone either a total mastectomy or breast conserving surgery
boolean
C0024886 (UMLS CUI [1])
C0917927 (UMLS CUI [2])
Specimen Resected | Surgical margins Free of Invasive cancer
Item
2. surgical margins of the resected specimen must be histologically free of invasive tumor.
boolean
C0370003 (UMLS CUI [1,1])
C1521996 (UMLS CUI [1,2])
C0229985 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0677898 (UMLS CUI [2,3])
Informed Consent
Item
signed informed consent obtained prior to any study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma epithelial TNM Breast tumor staging
Item
histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ).
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
Histology High risk of Relapse | Histology Low Risk Relapse | Sarcoma | Carcinoma, Tubular
Item
special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma)
boolean
C4048239 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,3])
C4048239 (UMLS CUI [2,1])
C3538919 (UMLS CUI [2,2])
C0035020 (UMLS CUI [2,3])
C1261473 (UMLS CUI [3])
C0205645 (UMLS CUI [4])
Malignant Neoplasms TNM Breast tumor staging | Estrogen Receptor Measurement | Progesterone Receptor Measurement | HER2 Negative | Ki67 Measurement
Item
t1a and t1b tumors with all the following characteristics: g1-2 and n0 and re > 10%, rpg > 10% and her2 negative and ki67≤14%
boolean
C0006826 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C3811131 (UMLS CUI [2])
C3889640 (UMLS CUI [3])
C2348908 (UMLS CUI [4])
C4049944 (UMLS CUI [5])
Distant metastasis
Item
evidence of distant metastases
boolean
C1269798 (UMLS CUI [1])
Study Subject Participation Status | Requirement Follow-up Special
Item
patients participating to other clinical trials requiring follow-up not equal to standard
boolean
C2348568 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0205555 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated | Exception Uterine Cancer TNM clinical staging Treated
Item
previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage i uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0153567 (UMLS CUI [4,2])
C3258246 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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