ID

37774

Beskrivning

Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40; ODM derived from: https://clinicaltrials.gov/show/NCT01043055

Länk

https://clinicaltrials.gov/show/NCT01043055

Nyckelord

Versioner (1)
  1. 2019-08-23 2019-08-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01043055

Engelsk

Eligibility Breast Cancer NCT01043055

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for breast cancer patients for experimental group:
Beskrivning

Breast Carcinoma Patients | Group experimental

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0030705
UMLS CUI [2,1]
C0441833
UMLS CUI [2,2]
C1517586
1. patient is over the age of 40.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient is willing to participate as evidenced by signing the written informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. patient referred to the department of oncology/ surgery for operative treatment of breast cancer with previously detected disease. positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast ct, biopsy.
Beskrivning

Referral for Breast Carcinoma Surgery | Mammography | Tumor Markers Blood | Ultrasonography, Mammary | CT of breast | Biopsy of breast

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0543467
UMLS CUI [2]
C0024671
UMLS CUI [3,1]
C0041365
UMLS CUI [3,2]
C0005767
UMLS CUI [4]
C0080264
UMLS CUI [5]
C0412609
UMLS CUI [6]
C0405352
4. non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy).
Beskrivning

Patients untreated | Chemotherapy Absent | Pharmaceutical Preparations Hormonal Absent | Therapeutic radiology procedure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0458083
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0332197
5. patient without other cancer locations
Beskrivning

Cancer Other Location Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0332197
inclusion criteria for presumably healthy subjects for control group:
Beskrivning

Healthy Volunteers Control Group

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0009932
1. subjects over the age of 40.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. subjects who are willing to participate as evidenced by signing the written informed consent form.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. subjects who are presumably healthy and without breast pathologies' symptoms and family history of breast cancer, i.e., breast disease (except history of functional breast problems, e.g., mastitis within lactation period) has been ruled out based on physician anamnesis
Beskrivning

Absence Symptoms Breast Diseases | Family history of breast cancer Absent | Breast Disease out ruling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0006145
UMLS CUI [2,1]
C0559119
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006145
UMLS CUI [3,2]
C0332196
4. subjects with negative results of screening mammography.
Beskrivning

Screening mammography Result Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0203028
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1513916
5. subjects without taking of any hormonal medicines
Beskrivning

Pharmaceutical Preparations Hormonal Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0458083
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects with any known cancer in other internal organs or systems.
Beskrivning

Cancer Other Organ Internal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0205102
2. subjects with high fever presentation (more than 38.5).
Beskrivning

High fever

Datatyp

boolean

Alias
UMLS CUI [1]
C0743973
3. subjects with known breast disease undergoing treatment for the disease.
Beskrivning

Therapy Breast Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0006145
4. pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01043055

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Patients | Group experimental
Item
inclusion criteria for breast cancer patients for experimental group:
boolean
C0678222 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0441833 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Age
Item
1. patient is over the age of 40.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. patient is willing to participate as evidenced by signing the written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Referral for Breast Carcinoma Surgery | Mammography | Tumor Markers Blood | Ultrasonography, Mammary | CT of breast | Biopsy of breast
Item
3. patient referred to the department of oncology/ surgery for operative treatment of breast cancer with previously detected disease. positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast ct, biopsy.
boolean
C2585524 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0024671 (UMLS CUI [2])
C0041365 (UMLS CUI [3,1])
C0005767 (UMLS CUI [3,2])
C0080264 (UMLS CUI [4])
C0412609 (UMLS CUI [5])
C0405352 (UMLS CUI [6])
Patients untreated | Chemotherapy Absent | Pharmaceutical Preparations Hormonal Absent | Therapeutic radiology procedure Absent
Item
4. non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy).
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0458083 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Cancer Other Location Absent
Item
5. patient without other cancer locations
boolean
C1707251 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Healthy Volunteers Control Group
Item
inclusion criteria for presumably healthy subjects for control group:
boolean
C1708335 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Age
Item
1. subjects over the age of 40.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. subjects who are willing to participate as evidenced by signing the written informed consent form.
boolean
C0021430 (UMLS CUI [1])
Absence Symptoms Breast Diseases | Family history of breast cancer Absent | Breast Disease out ruling
Item
3. subjects who are presumably healthy and without breast pathologies' symptoms and family history of breast cancer, i.e., breast disease (except history of functional breast problems, e.g., mastitis within lactation period) has been ruled out based on physician anamnesis
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0006145 (UMLS CUI [1,3])
C0559119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006145 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Screening mammography Result Negative
Item
4. subjects with negative results of screening mammography.
boolean
C0203028 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Pharmaceutical Preparations Hormonal Absent
Item
5. subjects without taking of any hormonal medicines
boolean
C0013227 (UMLS CUI [1,1])
C0458083 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Cancer Other Organ Internal
Item
1. subjects with any known cancer in other internal organs or systems.
boolean
C1707251 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0205102 (UMLS CUI [1,3])
High fever
Item
2. subjects with high fever presentation (more than 38.5).
boolean
C0743973 (UMLS CUI [1])
Therapy Breast Disease
Item
3. subjects with known breast disease undergoing treatment for the disease.
boolean
C0087111 (UMLS CUI [1,1])
C0006145 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
4. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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