ID

37831

Beskrivning

Male Breast Cancer: Understanding the Biology for Improved Patient Care; ODM derived from: https://clinicaltrials.gov/show/NCT01101425

Länk

https://clinicaltrials.gov/show/NCT01101425

Nyckelord

Versioner (1)
  1. 2019-08-26 2019-08-26 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

26 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01101425

Engelsk

Eligibility Breast Cancer NCT01101425

1 Formulär  
Criteria
Beskrivning

Criteria

men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.
Beskrivning

Gender | Invasive carcinoma of breast Disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0872146
a ffpe tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory
Beskrivning

Formalin-fixed paraffin-embedded tissue specimen Primary tumor Required | Biopsy | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2711483
UMLS CUI [1,2]
C0677930
UMLS CUI [1,3]
C1514873
UMLS CUI [2]
C0005558
UMLS CUI [3]
C0543467
prospective part:
Beskrivning

Part prospective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0023981
all men, with histologically proven invasive breast cancer, newly presenting at the center irrespective of the stage of disease, initial diagnosis date or treatment received.
Beskrivning

Gender | Invasive carcinoma of breast | Study Subject Participation Status newly present | Independent of Disease stage | Date of diagnosis Initial | Treatment Initial

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C0750546
UMLS CUI [3,3]
C0150312
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0699749
UMLS CUI [5,1]
C2316983
UMLS CUI [5,2]
C0205265
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C0205265
patients cannot be registered in both the retrospective and protective parts of the study
Beskrivning

Study Subject Participation Status | Retrospective Study | Protection Study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0035363
UMLS CUI [3,1]
C1545588
UMLS CUI [3,2]
C0947630
patients who newly present at the center in the 3 months prior to center activation are still eligible as long as they were not previously included in the retrospective part of the study
Beskrivning

Study Subject Participation Status newly present | Participation Retrospective Study Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0750546
UMLS CUI [1,3]
C0150312
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0035363
UMLS CUI [2,3]
C0332196
before patient registration, written informed consent must be obtained according to ich/gcp, and national/local regulations.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
collection of left-over ffpe and frozen tumor samples as well as blood is optional.
Beskrivning

Formalin-fixed paraffin-embedded tissue specimen Residual Optional | Tumor tissue sample Frozen Optional | Blood specimen Optional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2711483
UMLS CUI [1,2]
C1609982
UMLS CUI [1,3]
C1518600
UMLS CUI [2,1]
C0475358
UMLS CUI [2,2]
C0016701
UMLS CUI [2,3]
C1518600
UMLS CUI [3,1]
C0178913
UMLS CUI [3,2]
C1518600
both parts:
Beskrivning

Parts Both

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C1706086
concomitant dcis or lcis are allowed only if invasive cancer is present.
Beskrivning

Noninfiltrating Intraductal Carcinoma allowed | Condition Invasive cancer Present | Lobular carcinoma in situ of breast allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1705253
UMLS CUI [2,2]
C0677898
UMLS CUI [2,3]
C0150312
UMLS CUI [3,1]
C0279563
UMLS CUI [3,2]
C0683607
patients should be 18 years or over at the time of diagnosis.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
the study will accept all stages of disease (e.g. early bc, locally advanced and metastatic disease) independent of the treatment received. patients with past or concurrent other malignancies are eligible.
Beskrivning

Disease stage All Acceptable | Early-Stage Breast Carcinoma | Locally advanced breast cancer | Neoplasm Metastasis | Independent of Treatment | Cancer Other Eligible

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0699749
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1879533
UMLS CUI [2]
C2986665
UMLS CUI [3]
C3495949
UMLS CUI [4]
C0027627
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0087111
UMLS CUI [6,1]
C1707251
UMLS CUI [6,2]
C1548635
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Similar models

Eligibility Breast Cancer NCT01101425

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Gender | Invasive carcinoma of breast Disease length
Item
men with histologically proven invasive breast carcinoma diagnosed since 1990 to 2010.
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Formalin-fixed paraffin-embedded tissue specimen Primary tumor Required | Biopsy | Operative Surgical Procedures
Item
a ffpe tissue sample from the primary tumor (e.g. biopsy or surgery) is mandatory
boolean
C2711483 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Part prospective
Item
prospective part:
boolean
C0449719 (UMLS CUI [1,1])
C0023981 (UMLS CUI [1,2])
Gender | Invasive carcinoma of breast | Study Subject Participation Status newly present | Independent of Disease stage | Date of diagnosis Initial | Treatment Initial
Item
all men, with histologically proven invasive breast cancer, newly presenting at the center irrespective of the stage of disease, initial diagnosis date or treatment received.
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C0750546 (UMLS CUI [3,2])
C0150312 (UMLS CUI [3,3])
C0332291 (UMLS CUI [4,1])
C0699749 (UMLS CUI [4,2])
C2316983 (UMLS CUI [5,1])
C0205265 (UMLS CUI [5,2])
C0087111 (UMLS CUI [6,1])
C0205265 (UMLS CUI [6,2])
Study Subject Participation Status | Retrospective Study | Protection Study
Item
patients cannot be registered in both the retrospective and protective parts of the study
boolean
C2348568 (UMLS CUI [1])
C0035363 (UMLS CUI [2])
C1545588 (UMLS CUI [3,1])
C0947630 (UMLS CUI [3,2])
Study Subject Participation Status newly present | Participation Retrospective Study Excluded
Item
patients who newly present at the center in the 3 months prior to center activation are still eligible as long as they were not previously included in the retrospective part of the study
boolean
C2348568 (UMLS CUI [1,1])
C0750546 (UMLS CUI [1,2])
C0150312 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C0035363 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Informed Consent
Item
before patient registration, written informed consent must be obtained according to ich/gcp, and national/local regulations.
boolean
C0021430 (UMLS CUI [1])
Formalin-fixed paraffin-embedded tissue specimen Residual Optional | Tumor tissue sample Frozen Optional | Blood specimen Optional
Item
collection of left-over ffpe and frozen tumor samples as well as blood is optional.
boolean
C2711483 (UMLS CUI [1,1])
C1609982 (UMLS CUI [1,2])
C1518600 (UMLS CUI [1,3])
C0475358 (UMLS CUI [2,1])
C0016701 (UMLS CUI [2,2])
C1518600 (UMLS CUI [2,3])
C0178913 (UMLS CUI [3,1])
C1518600 (UMLS CUI [3,2])
Parts Both
Item
both parts:
boolean
C0449719 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
Noninfiltrating Intraductal Carcinoma allowed | Condition Invasive cancer Present | Lobular carcinoma in situ of breast allowed
Item
concomitant dcis or lcis are allowed only if invasive cancer is present.
boolean
C0007124 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1705253 (UMLS CUI [2,1])
C0677898 (UMLS CUI [2,2])
C0150312 (UMLS CUI [2,3])
C0279563 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Age
Item
patients should be 18 years or over at the time of diagnosis.
boolean
C0001779 (UMLS CUI [1])
Disease stage All Acceptable | Early-Stage Breast Carcinoma | Locally advanced breast cancer | Neoplasm Metastasis | Independent of Treatment | Cancer Other Eligible
Item
the study will accept all stages of disease (e.g. early bc, locally advanced and metastatic disease) independent of the treatment received. patients with past or concurrent other malignancies are eligible.
boolean
C0699749 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C2986665 (UMLS CUI [2])
C3495949 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
C0332291 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1707251 (UMLS CUI [6,1])
C1548635 (UMLS CUI [6,2])
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