ID

38320

Beskrivning

Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01257152

Länk

https://clinicaltrials.gov/show/NCT01257152

Nyckelord

Versioner (1)
  1. 2019-10-10 2019-10-10 -
Rättsinnehavare

See clinicaltrials.gov

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10 oktober 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01257152

Engelsk

Eligibility Breast Neoplasms NCT01257152

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women ≥ 20 years in age;
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
Beskrivning

Gender | Breast-Conserving Surgery Invasive carcinoma of breast | Negative Surgical Margin | Therapeutic radiology procedure Completed

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0917927
UMLS CUI [2,2]
C0853879
UMLS CUI [3]
C1709157
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205197
no history of breast biopsy of the breast within 6 months prior to this study;
Beskrivning

Biopsy of breast Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C0332197
signed study-specific informed consent prior to registration;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
has not had contralateral mastectomy;
Beskrivning

Mastectomy Contralateral Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024881
UMLS CUI [1,2]
C0441988
UMLS CUI [1,3]
C0332197
no known metastatic disease;
Beskrivning

Neoplasm Metastasis Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332197
not pregnant or lactating;
Beskrivning

Pregnancy Absent | Breast Feeding Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
no present signs or symptoms of breast cancer [no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)].
Beskrivning

Sign or Symptom Absent Breast Carcinoma | Breast Palpable mass Absent | No nipple discharge | Bleeding from nipple Absent | Mass of axilla Absent | Absence Breast skin change Abnormal | Absence Nipples skin change Abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0678222
UMLS CUI [2,1]
C1403543
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0425813
UMLS CUI [4,1]
C0281789
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0238729
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0006141
UMLS CUI [6,3]
C1399787
UMLS CUI [6,4]
C0205161
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C0028109
UMLS CUI [7,3]
C1399787
UMLS CUI [7,4]
C0205161
no contraindications to mri examination.
Beskrivning

Medical contraindication Absent MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0024485
no prior mri, us or mammography within the 6 months prior to the study.
Beskrivning

MRI Absent | Ultrasonography Absent | Mammography Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0041618
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0024671
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
had a screening contrast-enhanced breast mri within the past 24 months or diagnostic contrast-enhanced mri on any study breasts within the past 12 months;
Beskrivning

Contrast-enhanced MRI Breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707501
UMLS CUI [1,2]
C0006141
had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
Beskrivning

Operation on breast | Core biopsy of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C3714726
UMLS CUI [2]
C0842740
currently receiving chemotherapy [with exception to participant with personal history of cancer, and on chemoprevention with tamoxifen, evista (raloxifene), arimidex (anastrozole), aromasin (exemestane) or other aromatase inhibitor];
Beskrivning

Chemotherapy | Exception Individual Cancer History | Exception Chemoprevention Tamoxifen | Exception Evista | Exception Raloxifene | Exception Arimidex | Exception Anastrozole | Exception Aromasin | Exception Exemestane | Exception Aromatase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512706
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0282515
UMLS CUI [3,3]
C0039286
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0720318
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0244404
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0878174
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0290883
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0876723
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0851344
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0593802
participant with severely impaired renal function with estimated glomerular filtration rate (gfr) < 30 ml/min/1.73m2 and/or on dialysis.
Beskrivning

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
UMLS CUI [3]
C0011946
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Similar models

Eligibility Breast Neoplasms NCT01257152

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women ≥ 20 years in age;
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Breast-Conserving Surgery Invasive carcinoma of breast | Negative Surgical Margin | Therapeutic radiology procedure Completed
Item
women who underwent breast-conserving surgery for invasive breast cancer, whose final margins were negative and who finished radiation therapy at least 6 months prior to this study;
boolean
C0079399 (UMLS CUI [1])
C0917927 (UMLS CUI [2,1])
C0853879 (UMLS CUI [2,2])
C1709157 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Biopsy of breast Absent
Item
no history of breast biopsy of the breast within 6 months prior to this study;
boolean
C0405352 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
signed study-specific informed consent prior to registration;
boolean
C0021430 (UMLS CUI [1])
Mastectomy Contralateral Absent
Item
has not had contralateral mastectomy;
boolean
C0024881 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Neoplasm Metastasis Absent
Item
no known metastatic disease;
boolean
C0027627 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent
Item
not pregnant or lactating;
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Sign or Symptom Absent Breast Carcinoma | Breast Palpable mass Absent | No nipple discharge | Bleeding from nipple Absent | Mass of axilla Absent | Absence Breast skin change Abnormal | Absence Nipples skin change Abnormal
Item
no present signs or symptoms of breast cancer [no palpable mass(es), bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast(s) or nipple(s)].
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C1403543 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0425813 (UMLS CUI [3])
C0281789 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0238729 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0332197 (UMLS CUI [6,1])
C0006141 (UMLS CUI [6,2])
C1399787 (UMLS CUI [6,3])
C0205161 (UMLS CUI [6,4])
C0332197 (UMLS CUI [7,1])
C0028109 (UMLS CUI [7,2])
C1399787 (UMLS CUI [7,3])
C0205161 (UMLS CUI [7,4])
Medical contraindication Absent MRI
Item
no contraindications to mri examination.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
MRI Absent | Ultrasonography Absent | Mammography Absent
Item
no prior mri, us or mammography within the 6 months prior to the study.
boolean
C0024485 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0041618 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0024671 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Contrast-enhanced MRI Breast
Item
had a screening contrast-enhanced breast mri within the past 24 months or diagnostic contrast-enhanced mri on any study breasts within the past 12 months;
boolean
C1707501 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Operation on breast | Core biopsy of breast
Item
had breast surgery and/or a core biopsy on the study breast(s) performed within the prior 6 months on the study
boolean
C3714726 (UMLS CUI [1])
C0842740 (UMLS CUI [2])
Chemotherapy | Exception Individual Cancer History | Exception Chemoprevention Tamoxifen | Exception Evista | Exception Raloxifene | Exception Arimidex | Exception Anastrozole | Exception Aromasin | Exception Exemestane | Exception Aromatase Inhibitors
Item
currently receiving chemotherapy [with exception to participant with personal history of cancer, and on chemoprevention with tamoxifen, evista (raloxifene), arimidex (anastrozole), aromasin (exemestane) or other aromatase inhibitor];
boolean
C0392920 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512706 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0282515 (UMLS CUI [3,2])
C0039286 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0720318 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0244404 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0878174 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0290883 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0876723 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0851344 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0593802 (UMLS CUI [10,2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis
Item
participant with severely impaired renal function with estimated glomerular filtration rate (gfr) < 30 ml/min/1.73m2 and/or on dialysis.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
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