ID

35007

Description

MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study; ODM derived from: https://clinicaltrials.gov/show/NCT02301767

Lien

https://clinicaltrials.gov/show/NCT02301767

Mots-clés

Versions (1)
  1. 08/02/2019 08/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

8 février 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02301767

Anglais

Eligibility Breast Cancer NCT02301767

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligibility criteria for breast cancer cases
Description

Inclusion criteria Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0678222
women with the following characteristics at mri will be eligible as cases:
Description

Gender | Client Characteristics MRI

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0815172
UMLS CUI [2,2]
C0024485
1. have a newly diagnosed invasive unilateral breast cancer;
Description

Invasive carcinoma of breast Unilateral

Type de données

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
2. have a pre-surgical, pre-treatment mri available from the study site;
Description

MRI Preoperative | MRI Before Therapeutic procedure

Type de données

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0445204
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0087111
3. <70 years old at time of diagnosis; and
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
4. have an intact contralateral breast. the contralateral breast needs to be intact so mri reading can be done on the breast without cancer. women with a history of previous cancer diagnosis are excluded because treatment they may have received for these cancers might affect the mri readings.
Description

Breast Contralateral Intact | MRI Breast Intact

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C0441988
UMLS CUI [1,3]
C0205266
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0205266
eligibility criteria for controls controls will be women determined to be at high risk of developing breast cancer (i.e., lifetime risk ≥20%).30
Description

Inclusion criteria Control Group | Gender | High risk of Breast Carcinoma | Lifetime Risk Percentage Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0009932
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C1517878
UMLS CUI [4,2]
C0439165
UMLS CUI [4,3]
C0678222
in addition, they must meet the following criteria:
Description

Criteria Fulfill

Type de données

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. undergoing breast mri screening at one of the three study sites;
Description

Magnetic resonance imaging of breast

Type de données

boolean

Alias
UMLS CUI [1]
C0344104
2. <70 years old at time of mri; and
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. negative breast mri screen.
Description

Magnetic resonance imaging of breast Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0344104
UMLS CUI [1,2]
C1513916
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for either cases or controls:
Description

Exclusion Criteria Study Subject | Exclusion Criteria Control Group

Type de données

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0681850
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0009932
1. unable to speak and read english;
Description

Lacking Able to speak English Language | Lacking Able to read English Language

Type de données

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0586740
UMLS CUI [2,3]
C0376245
2. history of prophylactic mastectomy;
Description

Prophylactic Mastectomy

Type de données

boolean

Alias
UMLS CUI [1]
C2191320
3. history of pre-pectoral breast implants in either breast (sub-pectoral are acceptable);
Description

Breast implants

Type de données

boolean

Alias
UMLS CUI [1]
C0179412
4. history of breast reduction surgery;
Description

Reduction mammaplasty

Type de données

boolean

Alias
UMLS CUI [1]
C0191922
5. currently taking, or in the previous 3 months: hormonal medication such as tamoxifen (nolvadex), raloxifene (evista), aromatase inhibitors (anastrozole/arimidex, letrozole/femara, and/or exemestane/aromasin); and/or other postmenopausal hormonal therapy (pht) medication; and/or hormonal medication for fertility treatment;
Description

Pharmaceutical Preparations Hormonal | Tamoxifen | Nolvadex | Raloxifene | Evista | Aromatase Inhibitors | anastrozole | Arimidex | letrozole | Femara | exemestane | Aromasin | Hormone Therapy Postmenopausal | Fertility Agents Hormonal

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0458083
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0919390
UMLS CUI [4]
C0244404
UMLS CUI [5]
C0720318
UMLS CUI [6]
C0593802
UMLS CUI [7]
C0290883
UMLS CUI [8]
C0878174
UMLS CUI [9]
C0246421
UMLS CUI [10]
C0701348
UMLS CUI [11]
C0851344
UMLS CUI [12]
C0876723
UMLS CUI [13,1]
C0279025
UMLS CUI [13,2]
C0232970
UMLS CUI [14,1]
C0015896
UMLS CUI [14,2]
C0458083
6. currently, or in the preceding 6 months, pregnant or breast feeding; and
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. history of previous cancer, including ductal carcinoma in situ (dcis) (nonmelanoma skin cancer and cervical cancer in situ are acceptable).
Description

Malignant Neoplasms Previous | DCIS | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0007124
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
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Similar models

Eligibility Breast Cancer NCT02301767

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Breast Carcinoma
Item
eligibility criteria for breast cancer cases
boolean
C1512693 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Gender | Client Characteristics MRI
Item
women with the following characteristics at mri will be eligible as cases:
boolean
C0079399 (UMLS CUI [1])
C0815172 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
Invasive carcinoma of breast Unilateral
Item
1. have a newly diagnosed invasive unilateral breast cancer;
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
MRI Preoperative | MRI Before Therapeutic procedure
Item
2. have a pre-surgical, pre-treatment mri available from the study site;
boolean
C0024485 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Age
Item
3. <70 years old at time of diagnosis; and
boolean
C0001779 (UMLS CUI [1])
Breast Contralateral Intact | MRI Breast Intact
Item
4. have an intact contralateral breast. the contralateral breast needs to be intact so mri reading can be done on the breast without cancer. women with a history of previous cancer diagnosis are excluded because treatment they may have received for these cancers might affect the mri readings.
boolean
C0006141 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C0205266 (UMLS CUI [1,3])
C0024485 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0205266 (UMLS CUI [2,3])
Inclusion criteria Control Group | Gender | High risk of Breast Carcinoma | Lifetime Risk Percentage Breast Carcinoma
Item
eligibility criteria for controls controls will be women determined to be at high risk of developing breast cancer (i.e., lifetime risk ≥20%).30
boolean
C1512693 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0332167 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1517878 (UMLS CUI [4,1])
C0439165 (UMLS CUI [4,2])
C0678222 (UMLS CUI [4,3])
Criteria Fulfill
Item
in addition, they must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Magnetic resonance imaging of breast
Item
1. undergoing breast mri screening at one of the three study sites;
boolean
C0344104 (UMLS CUI [1])
Age
Item
2. <70 years old at time of mri; and
boolean
C0001779 (UMLS CUI [1])
Magnetic resonance imaging of breast Negative
Item
3. negative breast mri screen.
boolean
C0344104 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Study Subject | Exclusion Criteria Control Group
Item
for either cases or controls:
boolean
C0680251 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0009932 (UMLS CUI [2,2])
Lacking Able to speak English Language | Lacking Able to read English Language
Item
1. unable to speak and read english;
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0586740 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
Prophylactic Mastectomy
Item
2. history of prophylactic mastectomy;
boolean
C2191320 (UMLS CUI [1])
Breast implants
Item
3. history of pre-pectoral breast implants in either breast (sub-pectoral are acceptable);
boolean
C0179412 (UMLS CUI [1])
Reduction mammaplasty
Item
4. history of breast reduction surgery;
boolean
C0191922 (UMLS CUI [1])
Pharmaceutical Preparations Hormonal | Tamoxifen | Nolvadex | Raloxifene | Evista | Aromatase Inhibitors | anastrozole | Arimidex | letrozole | Femara | exemestane | Aromasin | Hormone Therapy Postmenopausal | Fertility Agents Hormonal
Item
5. currently taking, or in the previous 3 months: hormonal medication such as tamoxifen (nolvadex), raloxifene (evista), aromatase inhibitors (anastrozole/arimidex, letrozole/femara, and/or exemestane/aromasin); and/or other postmenopausal hormonal therapy (pht) medication; and/or hormonal medication for fertility treatment;
boolean
C0013227 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
C0919390 (UMLS CUI [3])
C0244404 (UMLS CUI [4])
C0720318 (UMLS CUI [5])
C0593802 (UMLS CUI [6])
C0290883 (UMLS CUI [7])
C0878174 (UMLS CUI [8])
C0246421 (UMLS CUI [9])
C0701348 (UMLS CUI [10])
C0851344 (UMLS CUI [11])
C0876723 (UMLS CUI [12])
C0279025 (UMLS CUI [13,1])
C0232970 (UMLS CUI [13,2])
C0015896 (UMLS CUI [14,1])
C0458083 (UMLS CUI [14,2])
Pregnancy | Breast Feeding
Item
6. currently, or in the preceding 6 months, pregnant or breast feeding; and
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Previous | DCIS | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
7. history of previous cancer, including ductal carcinoma in situ (dcis) (nonmelanoma skin cancer and cervical cancer in situ are acceptable).
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
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