ID

38248

Description

A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01344109

Link

https://clinicaltrials.gov/show/NCT01344109

Keywords

Versions (1)
  1. 10/2/19 10/2/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 2, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01344109

English

Eligibility Breast Neoplasms NCT01344109

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with biopsy proven invasive carcinoma of the breast
Description

Gender | Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
women with locally advanced breast cancer and breast tumors measuring >/= 2cm who are deemed candidates for preoperative chemotherapy
Description

Gender | Locally advanced breast cancer | Breast Carcinoma Size | Patients Appropriate Preoperative Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3495949
UMLS CUI [3,1]
C0678222
UMLS CUI [3,2]
C0456389
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548787
UMLS CUI [4,3]
C2347669
age >/= 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
expected survival >/= 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group performance status of 0, 1, or 2 at initiation of study
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
initial required laboratory values:
Description

Laboratory Results Required

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
absolute neutrophil count >/= 1.5 x 10(9)/l platelet count >/= 100,000 x 10(9)/l creatinine clearance >/= 50ml/min (calculated by cockcroft-gault method) liver function tests (ast, alt, total bilirubin) </= 2.5 x uln urine or serum hcg negative (if female of childbearing potential)
Description

Absolute neutrophil count | Platelet Count measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver Function Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C2711451
UMLS CUI [4]
C0023901
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C1278039
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0430057
UMLS CUI [9,1]
C3831118
UMLS CUI [9,2]
C0430060
UMLS CUI [9,3]
C1513916
women may be enrolled on ongoing therapeutic preoperative chemotherapy trials
Description

Gender | Study Subject Participation Status | Preoperative Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C2348568
UMLS CUI [3]
C2347669
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior chemotherapy for breast cancer
Description

Prior Chemotherapy Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0678222
no limitations for prior radiation therapy
Description

Limitation Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0279134
no active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
Description

Communicable Disease Serious Interferes with Study Subject Participation Status | Illness Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
non-pregnant and non-nursing patients only. patients of reproductive potential must agree to use an effective means of birth control
Description

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
no prior liver transplant or bone marrow transplant
Description

Transplantation of liver | Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0023911
UMLS CUI [2]
C0005961
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Similar models

Eligibility Breast Neoplasms NCT01344109

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Invasive carcinoma of breast
Item
women with biopsy proven invasive carcinoma of the breast
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Gender | Locally advanced breast cancer | Breast Carcinoma Size | Patients Appropriate Preoperative Chemotherapy
Item
women with locally advanced breast cancer and breast tumors measuring >/= 2cm who are deemed candidates for preoperative chemotherapy
boolean
C0079399 (UMLS CUI [1])
C3495949 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C2347669 (UMLS CUI [4,3])
Age
Item
age >/= 18 years old
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
expected survival >/= 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0, 1, or 2 at initiation of study
boolean
C1520224 (UMLS CUI [1])
Laboratory Results Required
Item
initial required laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver Function Tests | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
absolute neutrophil count >/= 1.5 x 10(9)/l platelet count >/= 100,000 x 10(9)/l creatinine clearance >/= 50ml/min (calculated by cockcroft-gault method) liver function tests (ast, alt, total bilirubin) </= 2.5 x uln urine or serum hcg negative (if female of childbearing potential)
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C2711451 (UMLS CUI [3])
C0023901 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C1278039 (UMLS CUI [7])
C3831118 (UMLS CUI [8,1])
C0430057 (UMLS CUI [8,2])
C3831118 (UMLS CUI [9,1])
C0430060 (UMLS CUI [9,2])
C1513916 (UMLS CUI [9,3])
Gender | Study Subject Participation Status | Preoperative Chemotherapy
Item
women may be enrolled on ongoing therapeutic preoperative chemotherapy trials
boolean
C0079399 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2347669 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Breast Carcinoma
Item
no prior chemotherapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Limitation Prior radiation therapy
Item
no limitations for prior radiation therapy
boolean
C0449295 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
Communicable Disease Serious Interferes with Study Subject Participation Status | Illness Interferes with Study Subject Participation Status | Mental disorder Interferes with Study Subject Participation Status
Item
no active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods
Item
non-pregnant and non-nursing patients only. patients of reproductive potential must agree to use an effective means of birth control
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Transplantation of liver | Bone Marrow Transplantation
Item
no prior liver transplant or bone marrow transplant
boolean
C0023911 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
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