ID

38334

Description

Axillary Ultrasound With or Without Sentinel Lymph Node Biopsy in Detecting the Spread of Breast Cancer in Patients Receiving Breast Conservation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01821768

Link

https://clinicaltrials.gov/show/NCT01821768

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01821768

English

Eligibility Breast Neoplasms NCT01821768

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be female.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
patient must be at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (t1 or t2 n0 m0)
Description

Tumor size TNM Breast tumor staging | Lymph node palpable Absent | Neoplasm Metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C1112395
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
patient must have a negative (normal) axillary ultrasound performed at siteman cancer center. lymph nodes will be evaluated based on morphologic features. aus wil be considered positive (abnormal)if lymph nodes are noted to be completely hypoechoic (absent hilum) or have focal hypoechoic cortical thickening/lobulation greater than 4 mm.
Description

Negative Axillary Lymph Node Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0279781
UMLS CUI [1,2]
C0041618
patient must have a tissue diagnosis of invasive breast carcinoma
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
patient must have eastern cooperative oncology group (ecog) status </= 2, as documented in patient's medical record.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patient must be available for follow-up.
Description

Patient Available Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
a patient with a history of previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. a cancer survivor is eligible provided that the following criteria are met (1) the patient has undergone potentially curative therapy for all prior malignancies; (2) there has been no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone); and (3) the patient is deemed by their treating physician to be at low riks for recurrence from prior malignancies.
Description

Malignant Neoplasms Previous | Criteria Fulfill | Curative treatment Malignant Neoplasms Previous | Recurrence Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Surgery Carcinoma in situ of uterine cervix | Exception Surgery Lobular carcinoma in situ of breast Ipsilateral | Exception Surgery Lobular carcinoma in situ of breast Contralateral | Low Risk Cancer recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C0205156
UMLS CUI [4,1]
C0034897
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007117
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0553723
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0543467
UMLS CUI [7,3]
C0851140
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0543467
UMLS CUI [8,3]
C0279563
UMLS CUI [8,4]
C0441989
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0543467
UMLS CUI [9,3]
C0279563
UMLS CUI [9,4]
C0441988
UMLS CUI [10,1]
C3538919
UMLS CUI [10,2]
C0920420
patient, or the patient's legally acceptable representative, must provide a signed and date written informed consent prior to registration and any study-related procedures.
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient must provide written authorization to allow the use and disclosure of their protected health information. note: this may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
Description

Authorization Use of Health information

Data type

boolean

Alias
UMLS CUI [1,1]
C0680281
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0850397
patient must be a candidate for sentinel lymph node biopsy (slnb).
Description

Patient Appropriate Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0796693
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient in lactating (breast-feeding) or pregnant.
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
patient has concurrent invasive bilateral breast malignancies or multicentric disease.
Description

Invasive carcinoma of breast Bilateral | Disease Multicentric

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0439743
patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph nodes(s), treatment of hidradenitis.
Description

Surgery Axillary lymph nodes Ipsilateral | Excisional biopsy of lymph node | Therapeutic procedure Hidradenitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C0441989
UMLS CUI [2]
C0553989
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0085160
patient is considered poor candidate surgical candidate due to non-malignant systemic disease.
Description

Appropriateness Poor Operative Surgical Procedure | Etiology Systemic disease | Exception Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0814634
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0442893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
patient has undergone or plans to undergo neoadjuvant chemotherapy of endocrine therapy.
Description

Neoadjuvant Chemotherapy | Hormone Therapy | Neoadjuvant Chemotherapy Planned | Hormone Therapy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [2]
C0279025
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C1301732
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Similar models

Eligibility Breast Neoplasms NCT01821768

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
patient must be female.
boolean
C0079399 (UMLS CUI [1])
Age
Item
patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Tumor size TNM Breast tumor staging | Lymph node palpable Absent | Neoplasm Metastasis Absent
Item
patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (t1 or t2 n0 m0)
boolean
C0475440 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1112395 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Negative Axillary Lymph Node Ultrasonography
Item
patient must have a negative (normal) axillary ultrasound performed at siteman cancer center. lymph nodes will be evaluated based on morphologic features. aus wil be considered positive (abnormal)if lymph nodes are noted to be completely hypoechoic (absent hilum) or have focal hypoechoic cortical thickening/lobulation greater than 4 mm.
boolean
C0279781 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
Invasive carcinoma of breast
Item
patient must have a tissue diagnosis of invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
ECOG performance status
Item
patient must have eastern cooperative oncology group (ecog) status </= 2, as documented in patient's medical record.
boolean
C1520224 (UMLS CUI [1])
Patient Available Follow-up
Item
patient must be available for follow-up.
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Malignant Neoplasms Previous | Criteria Fulfill | Curative treatment Malignant Neoplasms Previous | Recurrence Absent | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Surgery Carcinoma in situ of uterine cervix | Exception Surgery Lobular carcinoma in situ of breast Ipsilateral | Exception Surgery Lobular carcinoma in situ of breast Contralateral | Low Risk Cancer recurrence
Item
a patient with a history of previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. a cancer survivor is eligible provided that the following criteria are met (1) the patient has undergone potentially curative therapy for all prior malignancies; (2) there has been no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone); and (3) the patient is deemed by their treating physician to be at low riks for recurrence from prior malignancies.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0205156 (UMLS CUI [3,3])
C0034897 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0553723 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0543467 (UMLS CUI [7,2])
C0851140 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0543467 (UMLS CUI [8,2])
C0279563 (UMLS CUI [8,3])
C0441989 (UMLS CUI [8,4])
C1705847 (UMLS CUI [9,1])
C0543467 (UMLS CUI [9,2])
C0279563 (UMLS CUI [9,3])
C0441988 (UMLS CUI [9,4])
C3538919 (UMLS CUI [10,1])
C0920420 (UMLS CUI [10,2])
Informed Consent | Informed Consent Patient Representative
Item
patient, or the patient's legally acceptable representative, must provide a signed and date written informed consent prior to registration and any study-related procedures.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Authorization Use of Health information
Item
patient must provide written authorization to allow the use and disclosure of their protected health information. note: this may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.
boolean
C0680281 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0850397 (UMLS CUI [1,3])
Patient Appropriate Sentinel Lymph Node Biopsy
Item
patient must be a candidate for sentinel lymph node biopsy (slnb).
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Breast Feeding | Pregnancy
Item
patient in lactating (breast-feeding) or pregnant.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Invasive carcinoma of breast Bilateral | Disease Multicentric
Item
patient has concurrent invasive bilateral breast malignancies or multicentric disease.
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0439743 (UMLS CUI [2,2])
Surgery Axillary lymph nodes Ipsilateral | Excisional biopsy of lymph node | Therapeutic procedure Hidradenitis
Item
patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph nodes(s), treatment of hidradenitis.
boolean
C0543467 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0553989 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0085160 (UMLS CUI [3,2])
Appropriateness Poor Operative Surgical Procedure | Etiology Systemic disease | Exception Malignant Neoplasms
Item
patient is considered poor candidate surgical candidate due to non-malignant systemic disease.
boolean
C0814634 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0442893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
Neoadjuvant Chemotherapy | Hormone Therapy | Neoadjuvant Chemotherapy Planned | Hormone Therapy Planned
Item
patient has undergone or plans to undergo neoadjuvant chemotherapy of endocrine therapy.
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0279025 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
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