ID

34996

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.02.19 07.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02261389

Englisch

Eligibility Breast Cancer NCT02261389

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Breast Carcinoma epithelial TNM Breast tumor staging

Datentyp

boolean

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

Operation on breast | Axilla Operative Surgical Procedures

Datentyp

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
Beschreibung

Total mastectomy | Breast-Conserving Surgery

Datentyp

boolean

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

Specimen Resected | Surgical margins Free of Invasive cancer

Datentyp

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.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Breast Carcinoma epithelial TNM Breast tumor staging

Datentyp

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)
Beschreibung

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

Datentyp

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%
Beschreibung

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

Datentyp

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
Beschreibung

Distant metastasis

Datentyp

boolean

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

Study Subject Participation Status | Requirement Follow-up Special

Datentyp

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)
Beschreibung

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

Datentyp

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
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Ähnliche Modelle

Eligibility Breast Cancer NCT02261389

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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