ID

23642

Description

Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP); ODM derived from: https://clinicaltrials.gov/show/NCT00968409

Link

https://clinicaltrials.gov/show/NCT00968409

Keywords

Versions (1)
  1. 7/10/17 7/10/17 -
Uploaded on

July 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00968409

English

Eligibility Breast Cancer NCT00968409

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients 18 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
biopsy-proven breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
Description

Tumor Estrogen Receptor Status Determination | Tumor Progesterone Receptor Status Determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1516974
UMLS CUI [1,3]
C1148554
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1514471
UMLS CUI [2,3]
C1148554
primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, ct or mri) or physical examination
Description

Lesion size Primary Imaging studies | Ultrasonography | Mammography | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1881134
UMLS CUI [2]
C0041618
UMLS CUI [3]
C0024671
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0031809
able to give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
not currently pregnant or nursing: subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of ffnp) is negative.
Description

Pregnancy Absent | Breast Feeding Absent | Female Sterilization | Bilateral oophorectomy | Hysterectomy | Postmenopausal state | Amenorrhea | Childbearing Potential Urine pregnancy test negative | FFNP

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0278321
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0232970
UMLS CUI [7]
C0002453
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0430057
UMLS CUI [9]
C2981786
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no previous history of hormone therapy; note - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
Description

invasive cancer | Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2]
C0699893
unable to tolerate 60-90 minutes of pet imaging per imaging session
Description

Positron-Emission Tomography Minute Quantity Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439232
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1299582
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Similar models

Eligibility Breast Cancer NCT00968409

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
biopsy-proven breast cancer
boolean
C0678222 (UMLS CUI [1])
Tumor Estrogen Receptor Status Determination | Tumor Progesterone Receptor Status Determination
Item
tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
boolean
C0027651 (UMLS CUI [1,1])
C1516974 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1514471 (UMLS CUI [2,2])
C1148554 (UMLS CUI [2,3])
Lesion size Primary Imaging studies | Ultrasonography | Mammography | X-Ray Computed Tomography | Magnetic Resonance Imaging | Physical Examination
Item
primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, ct or mri) or physical examination
boolean
C0449453 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1881134 (UMLS CUI [1,3])
C0041618 (UMLS CUI [2])
C0024671 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0031809 (UMLS CUI [6])
Informed Consent
Item
able to give informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Female Sterilization | Bilateral oophorectomy | Hysterectomy | Postmenopausal state | Amenorrhea | Childbearing Potential Urine pregnancy test negative | FFNP
Item
not currently pregnant or nursing: subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of ffnp) is negative.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0002453 (UMLS CUI [7])
C3831118 (UMLS CUI [8,1])
C0430057 (UMLS CUI [8,2])
C2981786 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy
Item
no previous history of hormone therapy; note - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
boolean
C0279025 (UMLS CUI [1])
invasive cancer | Skin carcinoma
Item
patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
Positron-Emission Tomography Minute Quantity Unable
Item
unable to tolerate 60-90 minutes of pet imaging per imaging session
boolean
C0032743 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
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