ID

37984

Beschrijving

Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01386411

Link

https://clinicaltrials.gov/show/NCT01386411

Trefwoorden

Versies (1)
  1. 05-09-19 05-09-19 -
Houder van rechten

See clinicaltrials.gov

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5 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01386411

Engels

Eligibility Breast Cancer NCT01386411

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of invasive breast cancer or dcis
Beschrijving

Invasive carcinoma of breast | Noninfiltrating Intraductal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0007124
appropriate for genetic testing, defined as if they meeting one or more of the following criteria (note that patients may be appropriate for genetic testing even if they do not meet these criteria, but nccn and most payers recognize these groups as clearly appropriate for testing)
Beschrijving

Patients Appropriate Genetic testing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0679560
must be a primary malignancy (not recurrence), but can be second diagnosis if is a contralateral cancer and the first cancer was not treated with mastectomy
Beschrijving

Primary tumor | Diagnosis second Contralateral breast cancer | Mastectomy Absent Primary tumor

Datatype

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205436
UMLS CUI [2,3]
C1096616
UMLS CUI [3,1]
C0024881
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0677930
female age ≥18,
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
if ashkenazi jewish: breast cancer diagnosis ≤ 60. subjects will be presumed to be of ashkenazi ethnicity if jewish religious preference is confirmed in subject and at least 1 parent, unless they explicitly endorse sephardic, iranian, yemeni/ethiopian, or bukharan jewish decent, in which case non-ashkenazi criteria will be applied.
Beschrijving

Ashkenazi Jewish | Breast Carcinoma | Age | Exception Sephardic Jew | Exception Iranian | Exception Born in Yemen | Exception Ethiopian | Other Coding

Datatype

boolean

Alias
UMLS CUI [1]
C3844810
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0574825
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1553355
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1277445
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0239304
UMLS CUI [8]
C3846158
if not ashkenazi jewish:
Beschrijving

Patients | Exception Ashkenazi Jewish

Datatype

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3844810
breast cancer diagnosis ≤ 45 or
Beschrijving

Breast Carcinoma | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0001779
bilateral breast cancer, with first diagnosed ≤ 50 or
Beschrijving

Bilateral breast cancer | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0281267
UMLS CUI [2]
C0001779
breast cancer diagnosed at any age with a male relative with breast cancer or
Beschrijving

Breast Carcinoma | Age | Gender Relative Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0080103
UMLS CUI [3,3]
C0678222
breast cancer diagnosis ≤ 50 with one or more of the following::
Beschrijving

Breast Carcinoma | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0001779
1 or more relative with breast cancer ≤ 50 or
Beschrijving

Relative Quantity | Breast Carcinoma | Age

Datatype

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0001779
1 or more relative with ovarian cancer
Beschrijving

Relative Quantity | Ovarian neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0919267
have not completed definitive surgical treatment
Beschrijving

Operative Surgical Procedure Incomplete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205257
for patients planning mastectomy for treatment, has not yet undergone mastectomy
Beschrijving

Mastectomy Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C1301732
for patients planning breast conservation for treatment, has not yet begun adjuvant radiation therapy
Beschrijving

Breast-Conservation treatment Planned | Adjuvant Radiation Therapy Absent presently

Datatype

boolean

Alias
UMLS CUI [1,1]
C0917927
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1706721
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0750528
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
lcis without invasive cancer (idc or ilc) and without dcis
Beschrijving

Lobular carcinoma in situ of breast | Invasive Ductal Breast Carcinoma Absent | Invasive Lobular Breast Carcinoma Absent | DCIS Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0279563
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0279565
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0007124
UMLS CUI [4,2]
C0332197
previous breast cancer treated with mastectomy
Beschrijving

Mastectomy Breast Carcinoma Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205156
plan for neoadjuvant chemotherapy before surgery
Beschrijving

Neoadjuvant Chemotherapy Planned | Status pre- Operative Surgical Procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C3665472
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0543467
unable to complete english language questionnaires, as instruments have not been validated in non-english speaking populations
Beschrijving

English Language Questionnaires Completion Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0376245
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C1299582
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Similar models

Eligibility Breast Cancer NCT01386411

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Noninfiltrating Intraductal Carcinoma
Item
diagnosis of invasive breast cancer or dcis
boolean
C0853879 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
Patients Appropriate Genetic testing
Item
appropriate for genetic testing, defined as if they meeting one or more of the following criteria (note that patients may be appropriate for genetic testing even if they do not meet these criteria, but nccn and most payers recognize these groups as clearly appropriate for testing)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0679560 (UMLS CUI [1,3])
Primary tumor | Diagnosis second Contralateral breast cancer | Mastectomy Absent Primary tumor
Item
must be a primary malignancy (not recurrence), but can be second diagnosis if is a contralateral cancer and the first cancer was not treated with mastectomy
boolean
C0677930 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C1096616 (UMLS CUI [2,3])
C0024881 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
Gender | Age
Item
female age ≥18,
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Ashkenazi Jewish | Breast Carcinoma | Age | Exception Sephardic Jew | Exception Iranian | Exception Born in Yemen | Exception Ethiopian | Other Coding
Item
if ashkenazi jewish: breast cancer diagnosis ≤ 60. subjects will be presumed to be of ashkenazi ethnicity if jewish religious preference is confirmed in subject and at least 1 parent, unless they explicitly endorse sephardic, iranian, yemeni/ethiopian, or bukharan jewish decent, in which case non-ashkenazi criteria will be applied.
boolean
C3844810 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0574825 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1553355 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1277445 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0239304 (UMLS CUI [7,2])
C3846158 (UMLS CUI [8])
Patients | Exception Ashkenazi Jewish
Item
if not ashkenazi jewish:
boolean
C0030705 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3844810 (UMLS CUI [2,2])
Breast Carcinoma | Age
Item
breast cancer diagnosis ≤ 45 or
boolean
C0678222 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Bilateral breast cancer | Age
Item
bilateral breast cancer, with first diagnosed ≤ 50 or
boolean
C0281267 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma | Age | Gender Relative Breast Carcinoma
Item
breast cancer diagnosed at any age with a male relative with breast cancer or
boolean
C0678222 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0080103 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
Breast Carcinoma | Age
Item
breast cancer diagnosis ≤ 50 with one or more of the following::
boolean
C0678222 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Relative Quantity | Breast Carcinoma | Age
Item
1 or more relative with breast cancer ≤ 50 or
boolean
C0080103 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Relative Quantity | Ovarian neoplasm
Item
1 or more relative with ovarian cancer
boolean
C0080103 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0919267 (UMLS CUI [2])
Operative Surgical Procedure Incomplete
Item
have not completed definitive surgical treatment
boolean
C0543467 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
Mastectomy Planned
Item
for patients planning mastectomy for treatment, has not yet undergone mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Breast-Conservation treatment Planned | Adjuvant Radiation Therapy Absent presently
Item
for patients planning breast conservation for treatment, has not yet begun adjuvant radiation therapy
boolean
C0917927 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1706721 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0750528 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Lobular carcinoma in situ of breast | Invasive Ductal Breast Carcinoma Absent | Invasive Lobular Breast Carcinoma Absent | DCIS Absent
Item
lcis without invasive cancer (idc or ilc) and without dcis
boolean
C0279563 (UMLS CUI [1])
C1134719 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279565 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0007124 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Mastectomy Breast Carcinoma Previous
Item
previous breast cancer treated with mastectomy
boolean
C0024881 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Neoadjuvant Chemotherapy Planned | Status pre- Operative Surgical Procedure
Item
plan for neoadjuvant chemotherapy before surgery
boolean
C0600558 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
English Language Questionnaires Completion Unable
Item
unable to complete english language questionnaires, as instruments have not been validated in non-english speaking populations
boolean
C0376245 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
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