ID

37774

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01043055

Trefwoorden

Versies (1)
  1. 23-08-19 23-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 augustus 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT01043055

Engels

Eligibility Breast Cancer NCT01043055

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Breast Carcinoma Patients | Group experimental

Datatype

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.
Beschrijving

Age

Datatype

boolean

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

Informed Consent

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

Cancer Other Location Absent

Datatype

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:
Beschrijving

Healthy Volunteers Control Group

Datatype

boolean

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

Age

Datatype

boolean

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

Informed Consent

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

Screening mammography Result Negative

Datatype

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
Beschrijving

Pharmaceutical Preparations Hormonal Absent

Datatype

boolean

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

Exclusion Criteria

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

Cancer Other Organ Internal

Datatype

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).
Beschrijving

High fever

Datatype

boolean

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

Therapy Breast Disease

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT01043055

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial