ID

15386

Beschrijving

Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02376413

Link

https://clinicaltrials.gov/show/NCT02376413

Trefwoorden

  1. 29-05-16 29-05-16 -
Geüploaded op

29 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
ecog<=2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
Beschrijving

Breast Carcinoma | Unilateral Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1710547
operable or operable after neoadjuvant chemotherapy.
Beschrijving

Operable | Operable Post Neoadjuvant Therapy Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0205188
UMLS CUI [2,1]
C0205188
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0600558
UMLS CUI [2,4]
C3665472
extensive, diffuse micro-calcifications on mammography before surgery
Beschrijving

Diffuse microcalcifications of breast Extensive | Mammography Before Operative Surgical Procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C2919226
UMLS CUI [1,2]
C0205231
UMLS CUI [2,1]
C0024671
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0543467
no history of breast surgery or breast radiation therapy before.
Beschrijving

Operation on breast | Radiotherapy to breast

Datatype

boolean

Alias
UMLS CUI [1]
C3714726
UMLS CUI [2]
C0948310
able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.
Beschrijving

Standard of Care Compliance behavior | Chemotherapy, Adjuvant | Therapeutic radiology procedure | Hormone Therapy | Targeted Therapy | Operative Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C1321605
UMLS CUI [2]
C0085533
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0279025
UMLS CUI [5]
C2985566
UMLS CUI [6]
C0543467
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
multifocal/multicentric diseases noticed before surgery.
Beschrijving

Disease Multicentric | Disease Multifocal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439743
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205292
inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
Beschrijving

Inflammatory Breast Carcinoma | Invasive micropapillary carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C3838947
tumor size > 5 cm revealed by physical examination, ultrasound or mammography before surgery.
Beschrijving

Tumor size | Physical Examination | Ultrasonics (sound) | Mammography

Datatype

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0031809
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0024671
tumor size/breast size ratio >0.5 revealed by by physical examination, ultrasound or mammography before surgery.
Beschrijving

Tumor size Breast size Ratio | Physical Examination | Ultrasonics (sound) | Mammography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0425782
UMLS CUI [1,3]
C0456603
UMLS CUI [2]
C0031809
UMLS CUI [3]
C1456803
UMLS CUI [4]
C0024671
have other malignant tumors.
Beschrijving

Malignant Neoplasms Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
Beschrijving

Comorbidity Compliance behavior Limited | Comorbidity At risk patient safety

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
participated in other clinical trials.
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
pathologically confirmed metastatic breast cancer, bilateral breast cancer or dcis patients.
Beschrijving

Carcinoma breast stage IV | Bilateral breast cancer | Noninfiltrating Intraductal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2]
C0281267
UMLS CUI [3]
C0007124
patients with any organ failure.
Beschrijving

Single organ dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0349410
pregnancy women
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patients who desire to have mastectomy before surgery.
Beschrijving

Mastectomy Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C1301732

Similar models

Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
ecog<=2
boolean
C1520224 (UMLS CUI [1])
Breast Carcinoma | Unilateral Breast Carcinoma
Item
non-metastatic breast cancer patients with unilateral breast cancer confirmed by pathology.
boolean
C0678222 (UMLS CUI [1])
C1710547 (UMLS CUI [2])
Operable | Operable Post Neoadjuvant Therapy Chemotherapy
Item
operable or operable after neoadjuvant chemotherapy.
boolean
C0205188 (UMLS CUI [1])
C0205188 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C3665472 (UMLS CUI [2,4])
Diffuse microcalcifications of breast Extensive | Mammography Before Operative Surgical Procedure
Item
extensive, diffuse micro-calcifications on mammography before surgery
boolean
C2919226 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
C0024671 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Operation on breast | Radiotherapy to breast
Item
no history of breast surgery or breast radiation therapy before.
boolean
C3714726 (UMLS CUI [1])
C0948310 (UMLS CUI [2])
Standard of Care Compliance behavior | Chemotherapy, Adjuvant | Therapeutic radiology procedure | Hormone Therapy | Targeted Therapy | Operative Surgical Procedures
Item
able to follow the standard of care in adjuvant chemotherapy, radiation therapy, endocrine therapy and targeted therapy after surgery.
boolean
C2936643 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
C2985566 (UMLS CUI [5])
C0543467 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Disease Multicentric | Disease Multifocal
Item
multifocal/multicentric diseases noticed before surgery.
boolean
C0012634 (UMLS CUI [1,1])
C0439743 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205292 (UMLS CUI [2,2])
Inflammatory Breast Carcinoma | Invasive micropapillary carcinoma of breast
Item
inflammatory breast cancer or invasive micro-papillary carcinoma of the breast confirmed by pathology before surgery.
boolean
C0278601 (UMLS CUI [1])
C3838947 (UMLS CUI [2])
Tumor size | Physical Examination | Ultrasonics (sound) | Mammography
Item
tumor size > 5 cm revealed by physical examination, ultrasound or mammography before surgery.
boolean
C0475440 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0024671 (UMLS CUI [4])
Tumor size Breast size Ratio | Physical Examination | Ultrasonics (sound) | Mammography
Item
tumor size/breast size ratio >0.5 revealed by by physical examination, ultrasound or mammography before surgery.
boolean
C0475440 (UMLS CUI [1,1])
C0425782 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,3])
C0031809 (UMLS CUI [2])
C1456803 (UMLS CUI [3])
C0024671 (UMLS CUI [4])
Malignant Neoplasms Other
Item
have other malignant tumors.
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Comorbidity Compliance behavior Limited | Comorbidity At risk patient safety
Item
have severe co-morbidities that compromise the patients' compliance to our protocol, or endanger the patients.
boolean
C0009488 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Study Subject Participation Status
Item
participated in other clinical trials.
boolean
C2348568 (UMLS CUI [1])
Carcinoma breast stage IV | Bilateral breast cancer | Noninfiltrating Intraductal Carcinoma
Item
pathologically confirmed metastatic breast cancer, bilateral breast cancer or dcis patients.
boolean
C0278488 (UMLS CUI [1])
C0281267 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
Single organ dysfunction
Item
patients with any organ failure.
boolean
C0349410 (UMLS CUI [1])
Pregnancy
Item
pregnancy women
boolean
C0032961 (UMLS CUI [1])
Mastectomy Planned
Item
patients who desire to have mastectomy before surgery.
boolean
C0024881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])

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