ID

13307

Description

Collection of Tissue, Blood, and Cells to Be Used For Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00588029

Link

https://clinicaltrials.gov/show/NCT00588029

Keywords

Versions (1)
  1. 2/1/16 2/1/16 -
Uploaded on

February 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00588029

English

Eligibility Breast Cancer NCT00588029

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for acquisition of existing breast cancer tissue specimens from the mskcc tissue procurement service, the only criteria are a pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
Description

Breast Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205469
UMLS CUI [2,1]
C1518371
UMLS CUI [2,2]
C1548787
for the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:
Description

Inclusion criteria for control group

Data type

boolean

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0033522
UMLS CUI [2,1]
C0444155
UMLS CUI [2,2]
C0033522
any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
Description

invasive breast cancer: pleural fluid collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1285158
UMLS CUI [1,3]
C0032227
UMLS CUI [1,4]
C2239099
any female patient, or any female over the age of 18 accompanying a patient under the care of a physician in the department of urology, department of surgery, or department of medicine.
Description

gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
subjects will have no history of preinvasive (carcinoma in situ) or invasive breast cancer.
Description

breast cancer staging

Data type

boolean

Alias
UMLS CUI [1]
C0154084
UMLS CUI [2]
C0853879
subjects will be eligible without regard to racial, or ethnic status. attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
Description

participation status

Data type

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1709536
for the prospective acquisition of blood, saliva, pleural fluid or cerebrospinal fluid from patients who have or are suspected of having breast cancer or carcinoma in-situ, eligibility criteria include:
Description

inclusion criteria for breast cancer patients

Data type

boolean

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0033522
UMLS CUI [2,1]
C0444155
UMLS CUI [2,2]
C0033522
UMLS CUI [2,3]
C0033522
UMLS CUI [3,1]
C2239099
UMLS CUI [3,2]
C0033522
UMLS CUI [4,1]
C0394552
UMLS CUI [4,2]
C0033522
any patient at mskcc with a previously confirmed or suspected diagnosis of malignant or premalignant (e.g., carcinoma in situ) breast disease is eligible for inclusion in the blood acquisition aspect of this protocol.
Description

malignant or premalignant breast disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0006142
UMLS CUI [2,1]
C0190979
UMLS CUI [2,2]
C0154084
any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
Description

invasive breast cancer: pleural fluid collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1285158
UMLS CUI [1,3]
C0032227
UMLS CUI [1,4]
C2239099
any patient with a previous diagnosis of invasive breast cancer with leptomeningeal metastasis who undergoes a routine procedure associated with the collection of cerebrospinal fluid is eligible for the cerebrospinal fluid collection aspect of this protocol.
Description

invasive breast cancer: cerebrospinal fluid collection

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1704231
UMLS CUI [1,3]
C0394552
all subjects must be under the care of one or more members of the mskcc breast disease management team at the time of enrollment.
Description

Medical care

Data type

boolean

Alias
UMLS CUI [1]
C0031831
subjects may have received prior hormonal therapy, cytotoxic chemotherapy, radiation therapy, or surgical therapy at mskcc or another institution.
Description

Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0877050
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0851346
UMLS CUI [4]
C0543467
all subjects must be 18 years or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects will be eligible without regard to sex, racial, or ethnic status. it is anticipated that approximately 99% of the patients will be female. attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
Description

Participation status

Data type

boolean

Alias
UMLS CUI [1]
C0015031
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C1709536
if, after pathologic diagnosis, preinvasive or invasive breast disease is not found, patients previously consented for the blood collection aspect of this protocol will not be included.
Description

Pathological diagnsosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0154084
UMLS CUI [1,2]
C0205469
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205469
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for the prospective acquisition of blood or saliva from control subjects without breast cancer, ineligibility criteria include:
Description

Exclusion criteria for control group

Data type

boolean

Alias
UMLS CUI [1,1]
C0190979
UMLS CUI [1,2]
C0033522
UMLS CUI [2,1]
C0444155
UMLS CUI [2,2]
C0033522
a first degree relative (mother, daughter, sister, father, brother or son) who has been diagnosed with breast cancer.
Description

Family history of breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0559119
a personal history of breast cancer, lobular carcinoma in situ or atypia.
Description

History of breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0279563
UMLS CUI [3]
C0741302
UMLS CUI [4]
C0546458
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Similar models

Eligibility Breast Cancer NCT00588029

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Cancer
Item
for acquisition of existing breast cancer tissue specimens from the mskcc tissue procurement service, the only criteria are a pathologically-confirmed diagnosis of invasive breast cancer and the availability of corresponding nonmalignant tissue from each case.
boolean
C0853879 (UMLS CUI [1,1])
C0205469 (UMLS CUI [1,2])
C1518371 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
Inclusion criteria for control group
Item
for the prospective acquisition of blood or saliva from control subjects without breast cancer, eligibility criteria include:
boolean
C0190979 (UMLS CUI [1,1])
C0033522 (UMLS CUI [1,2])
C0444155 (UMLS CUI [2,1])
C0033522 (UMLS CUI [2,2])
invasive breast cancer: pleural fluid collection
Item
any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
boolean
C0853879 (UMLS CUI [1,1])
C1285158 (UMLS CUI [1,2])
C0032227 (UMLS CUI [1,3])
C2239099 (UMLS CUI [1,4])
gender
Item
any female patient, or any female over the age of 18 accompanying a patient under the care of a physician in the department of urology, department of surgery, or department of medicine.
boolean
C0079399 (UMLS CUI [1])
breast cancer staging
Item
subjects will have no history of preinvasive (carcinoma in situ) or invasive breast cancer.
boolean
C0154084 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
participation status
Item
subjects will be eligible without regard to racial, or ethnic status. attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
boolean
C0015031 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1709536 (UMLS CUI [2,3])
inclusion criteria for breast cancer patients
Item
for the prospective acquisition of blood, saliva, pleural fluid or cerebrospinal fluid from patients who have or are suspected of having breast cancer or carcinoma in-situ, eligibility criteria include:
boolean
C0190979 (UMLS CUI [1,1])
C0033522 (UMLS CUI [1,2])
C0444155 (UMLS CUI [2,1])
C0033522 (UMLS CUI [2,2])
C0033522 (UMLS CUI [2,3])
C2239099 (UMLS CUI [3,1])
C0033522 (UMLS CUI [3,2])
C0394552 (UMLS CUI [4,1])
C0033522 (UMLS CUI [4,2])
malignant or premalignant breast disease
Item
any patient at mskcc with a previously confirmed or suspected diagnosis of malignant or premalignant (e.g., carcinoma in situ) breast disease is eligible for inclusion in the blood acquisition aspect of this protocol.
boolean
C0190979 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C0190979 (UMLS CUI [2,1])
C0154084 (UMLS CUI [2,2])
invasive breast cancer: pleural fluid collection
Item
any patient with a previous diagnosis of invasive breast cancer who undergoes a palliative procedure related to the presence of a pleural effusion is eligible for the pleural fluid collection aspect of this protocol.
boolean
C0853879 (UMLS CUI [1,1])
C1285158 (UMLS CUI [1,2])
C0032227 (UMLS CUI [1,3])
C2239099 (UMLS CUI [1,4])
invasive breast cancer: cerebrospinal fluid collection
Item
any patient with a previous diagnosis of invasive breast cancer with leptomeningeal metastasis who undergoes a routine procedure associated with the collection of cerebrospinal fluid is eligible for the cerebrospinal fluid collection aspect of this protocol.
boolean
C0853879 (UMLS CUI [1,1])
C1704231 (UMLS CUI [1,2])
C0394552 (UMLS CUI [1,3])
Medical care
Item
all subjects must be under the care of one or more members of the mskcc breast disease management team at the time of enrollment.
boolean
C0031831 (UMLS CUI [1])
Therapy
Item
subjects may have received prior hormonal therapy, cytotoxic chemotherapy, radiation therapy, or surgical therapy at mskcc or another institution.
boolean
C0877050 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0851346 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
age
Item
all subjects must be 18 years or older
boolean
C0001779 (UMLS CUI [1])
Participation status
Item
subjects will be eligible without regard to sex, racial, or ethnic status. it is anticipated that approximately 99% of the patients will be female. attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., mentally impaired) reasons.
boolean
C0015031 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0021430 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C1709536 (UMLS CUI [3,3])
Pathological diagnsosis
Item
if, after pathologic diagnosis, preinvasive or invasive breast disease is not found, patients previously consented for the blood collection aspect of this protocol will not be included.
boolean
C0154084 (UMLS CUI [1,1])
C0205469 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0205469 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Exclusion criteria for control group
Item
for the prospective acquisition of blood or saliva from control subjects without breast cancer, ineligibility criteria include:
boolean
C0190979 (UMLS CUI [1,1])
C0033522 (UMLS CUI [1,2])
C0444155 (UMLS CUI [2,1])
C0033522 (UMLS CUI [2,2])
Family history of breast cancer
Item
a first degree relative (mother, daughter, sister, father, brother or son) who has been diagnosed with breast cancer.
boolean
C0559119 (UMLS CUI [1])
History of breast cancer
Item
a personal history of breast cancer, lobular carcinoma in situ or atypia.
boolean
C0678222 (UMLS CUI [1])
C0279563 (UMLS CUI [2])
C0741302 (UMLS CUI [3])
C0546458 (UMLS CUI [4])
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