ID

15386

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02376413

Nyckelord

  1. 2016-05-29 2016-05-29 -
Uppladdad den

29 maj 2016

DOI

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Licens

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
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent signed
Beskrivning

Informed consent

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Breast Carcinoma | Unilateral Breast Carcinoma

Datatyp

boolean

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

Operable | Operable Post Neoadjuvant Therapy Chemotherapy

Datatyp

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
Beskrivning

Diffuse microcalcifications of breast Extensive | Mammography Before Operative Surgical Procedure

Datatyp

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.
Beskrivning

Operation on breast | Radiotherapy to breast

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Exclusion Criteria

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

Disease Multicentric | Disease Multifocal

Datatyp

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.
Beskrivning

Inflammatory Breast Carcinoma | Invasive micropapillary carcinoma of breast

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Malignant Neoplasms Other

Datatyp

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.
Beskrivning

Comorbidity Compliance behavior Limited | Comorbidity At risk patient safety

Datatyp

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.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

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

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

Datatyp

boolean

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

Single organ dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0349410
pregnancy women
Beskrivning

Pregnancy

Datatyp

boolean

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

Mastectomy Planned

Datatyp

boolean

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

Similar models

Eligibility Local Recurrence of Malignant Tumor of Breast NCT02376413

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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