ID

37752

Descripción

A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.; ODM derived from: https://clinicaltrials.gov/show/NCT00816530

Link

https://clinicaltrials.gov/show/NCT00816530

Palabras clave

Versiones (1)
  1. 21/8/19 21/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

21 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00816530

Inglés

Eligibility Breast Cancer NCT00816530

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
asymptomatic
Descripción

Asymptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0231221
prior screening mammograms, if available, exhibit history of breast density
Descripción

Mammographic Breast Density

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1268717
not currently pregnant or breastfeeding
Descripción

Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
not planning to become pregnant in the following 18 months
Descripción

Planned Pregnancy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032992
UMLS CUI [1,2]
C0332197
age 25 or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
no breast surgeries or interventional procedures in the past 12 months
Descripción

Operation on breast Absent | Interventional procedure Breast Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3714726
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C0006141
UMLS CUI [2,3]
C0332197
no history of cancer diagnosis and/or treatment in the past 12 months
Descripción

Malignant Neoplasms Absent | Cancer treatment Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0332197
informed consent and completed participant questionnaire
Descripción

Informed Consent | Study Subject Questionnaire Completed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0034394
UMLS CUI [2,3]
C0205197
complete screening mammography views (cc and mlo) for one or both breasts
Descripción

Screening mammography Cranio-caudal projection Breast | Screening mammography View MLO Breast | Screening mammography Cranio-caudal projection Both breasts | Screening mammography View MLO Both breasts

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0203028
UMLS CUI [1,2]
C0442215
UMLS CUI [1,3]
C0006141
UMLS CUI [2,1]
C0203028
UMLS CUI [2,2]
C1508335
UMLS CUI [2,3]
C0006141
UMLS CUI [3,1]
C0203028
UMLS CUI [3,2]
C0442215
UMLS CUI [3,3]
C0222605
UMLS CUI [4,1]
C0203028
UMLS CUI [4,2]
C1508335
UMLS CUI [4,3]
C0222605
> 50% preliminary parenchymal density on preliminary assessment by technologist
Descripción

Parenchymal Tissue Density Percentage | Assessment Preliminary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4277702
UMLS CUI [1,2]
C0178587
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0439611
willing to comply with study protocol and follow-up recommendations:
Descripción

Protocol Compliance | Compliance Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
if evaluation is normal, must undergo routine screening mammography in 12 months
Descripción

Evaluation Normal | Screening mammography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0203028
if evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
Descripción

Evaluation Abnormal | Imaging Additional | Diagnostic procedure Additional | Biopsy | Screening mammography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1524062
UMLS CUI [3,1]
C0430022
UMLS CUI [3,2]
C1524062
UMLS CUI [4]
C0005558
UMLS CUI [5]
C0203028
agrees to report any breast changes or symptoms to the investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
Descripción

Report Breast changes | Report Breast symptoms | Screening mammography Completion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0700287
UMLS CUI [1,2]
C0558236
UMLS CUI [2,1]
C0700287
UMLS CUI [2,2]
C2220038
UMLS CUI [3,1]
C0203028
UMLS CUI [3,2]
C0205197
agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.
Descripción

Patient contacted by Research Personnel | Screening mammography Incomplete | Follow-up Incomplete

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2051442
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0203028
UMLS CUI [2,2]
C0205257
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C0205257
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
≤ 50% preliminary parenchymal density on preliminary assessment by technologist
Descripción

Parenchymal Tissue Density Percentage | Assessment Preliminary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4277702
UMLS CUI [1,2]
C0178587
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0439611
does not meet all inclusion criteria for enrollment
Descripción

Inclusion criteria Fulfill Incomplete

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0205257
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Similar models

Eligibility Breast Cancer NCT00816530

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Asymptomatic
Item
asymptomatic
boolean
C0231221 (UMLS CUI [1])
Mammographic Breast Density
Item
prior screening mammograms, if available, exhibit history of breast density
boolean
C1268717 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
not currently pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Planned Pregnancy Absent
Item
not planning to become pregnant in the following 18 months
boolean
C0032992 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Age
Item
age 25 or older
boolean
C0001779 (UMLS CUI [1])
Operation on breast Absent | Interventional procedure Breast Absent
Item
no breast surgeries or interventional procedures in the past 12 months
boolean
C3714726 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Malignant Neoplasms Absent | Cancer treatment Absent
Item
no history of cancer diagnosis and/or treatment in the past 12 months
boolean
C0006826 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Informed Consent | Study Subject Questionnaire Completed
Item
informed consent and completed participant questionnaire
boolean
C0021430 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Screening mammography Cranio-caudal projection Breast | Screening mammography View MLO Breast | Screening mammography Cranio-caudal projection Both breasts | Screening mammography View MLO Both breasts
Item
complete screening mammography views (cc and mlo) for one or both breasts
boolean
C0203028 (UMLS CUI [1,1])
C0442215 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C0203028 (UMLS CUI [2,1])
C1508335 (UMLS CUI [2,2])
C0006141 (UMLS CUI [2,3])
C0203028 (UMLS CUI [3,1])
C0442215 (UMLS CUI [3,2])
C0222605 (UMLS CUI [3,3])
C0203028 (UMLS CUI [4,1])
C1508335 (UMLS CUI [4,2])
C0222605 (UMLS CUI [4,3])
Parenchymal Tissue Density Percentage | Assessment Preliminary
Item
> 50% preliminary parenchymal density on preliminary assessment by technologist
boolean
C4277702 (UMLS CUI [1,1])
C0178587 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0439611 (UMLS CUI [2,2])
Protocol Compliance | Compliance Follow-up
Item
willing to comply with study protocol and follow-up recommendations:
boolean
C0525058 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
Evaluation Normal | Screening mammography
Item
if evaluation is normal, must undergo routine screening mammography in 12 months
boolean
C1261322 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0203028 (UMLS CUI [2])
Evaluation Abnormal | Imaging Additional | Diagnostic procedure Additional | Biopsy | Screening mammography
Item
if evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
boolean
C1261322 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0430022 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C0005558 (UMLS CUI [4])
C0203028 (UMLS CUI [5])
Report Breast changes | Report Breast symptoms | Screening mammography Completion
Item
agrees to report any breast changes or symptoms to the investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
boolean
C0700287 (UMLS CUI [1,1])
C0558236 (UMLS CUI [1,2])
C0700287 (UMLS CUI [2,1])
C2220038 (UMLS CUI [2,2])
C0203028 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Patient contacted by Research Personnel | Screening mammography Incomplete | Follow-up Incomplete
Item
agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.
boolean
C2051442 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0203028 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Parenchymal Tissue Density Percentage | Assessment Preliminary
Item
≤ 50% preliminary parenchymal density on preliminary assessment by technologist
boolean
C4277702 (UMLS CUI [1,1])
C0178587 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1516048 (UMLS CUI [2,1])
C0439611 (UMLS CUI [2,2])
Inclusion criteria Fulfill Incomplete
Item
does not meet all inclusion criteria for enrollment
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
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