ID

15386

Description

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

Link

https://clinicaltrials.gov/show/NCT02376413

Keywords

Versions (1)
  1. 5/29/16 5/29/16 -
Uploaded on

May 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

English

Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed
Description

Informed consent

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Breast Carcinoma | Unilateral Breast Carcinoma

Data type

boolean

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

Operable | Operable Post Neoadjuvant Therapy Chemotherapy

Data type

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
Description

Diffuse microcalcifications of breast Extensive | Mammography Before Operative Surgical Procedure

Data type

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.
Description

Operation on breast | Radiotherapy to breast

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Disease Multicentric | Disease Multifocal

Data type

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.
Description

Inflammatory Breast Carcinoma | Invasive micropapillary carcinoma of breast

Data type

boolean

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

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

Data type

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.
Description

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

Data type

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.
Description

Malignant Neoplasms Other

Data type

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.
Description

Comorbidity Compliance behavior Limited | Comorbidity At risk patient safety

Data type

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.
Description

Study Subject Participation Status

Data type

boolean

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

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

Data type

boolean

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

Single organ dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0349410
pregnancy women
Description

Pregnancy

Data type

boolean

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

Mastectomy Planned

Data type

boolean

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

Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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