ID

37809

Beschreibung

Proof of Principle Trial to Determine if Nutritional Supplement Conjugated Linoleic Acid (CLA) Can Modulate the Lipogenic Pathway in Breast Cancer Tissue; ODM derived from: https://clinicaltrials.gov/show/NCT00908791

Link

https://clinicaltrials.gov/show/NCT00908791

Stichworte

Versionen (1)
  1. 25.08.19 25.08.19 -
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See clinicaltrials.gov

Hochgeladen am

25. August 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00908791

Englisch

Eligibility Breast Cancer NCT00908791

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
all study patients must have histologically confirmed invasive adenocarcinoma of the breast. their breast cancer must be resectable clinical stage i or ii breast cancer as defined by the current ajcc tnm staging system (greene fl, page dl, fleming id, et al.: editors. ajcc cancer staging manual, 6th edition. new york: springer; 2002).
Beschreibung

Breast adenocarcinoma Invasive | Breast Carcinoma Resectable TNM Breast tumor staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C1514888
UMLS CUI [2,3]
C0474926
all patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
all subjects must be age >18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
all subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (ast or alt) ≤ 1.5 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤
Beschreibung

Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C1278039
UMLS CUI [6]
C0201976
1.5 times the upper limit of normal or ecrcl ≥ 60 ml/min.
Beschreibung

Creatinine clearance Estimated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151280
UMLS CUI [1,2]
C0750572
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.
Beschreibung

Therapeutic radiology procedure Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0678222
patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.
Beschreibung

Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678222
women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.
Beschreibung

Female Sterilization | Postmenopausal state | Childbearing Potential Contraceptive methods | Oral contraception | Contraceptive implant | Hormonal contraception Injectable | Intrauterine Devices | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Sexual Abstinence | Partner had vasectomy | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0029151
UMLS CUI [5]
C1657106
UMLS CUI [6,1]
C2985296
UMLS CUI [6,2]
C0086466
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0004764
UMLS CUI [9]
C0042241
UMLS CUI [10]
C0221829
UMLS CUI [11]
C0087145
UMLS CUI [12]
C0036899
UMLS CUI [13]
C0420842
UMLS CUI [14,1]
C3831118
UMLS CUI [14,2]
C0430061
UMLS CUI [15,1]
C3831118
UMLS CUI [15,2]
C0430057
UMLS CUI [16]
C0032961
UMLS CUI [17]
C0006147
UMLS CUI [18,1]
C3831118
UMLS CUI [18,2]
C0700589
UMLS CUI [18,3]
C0332197
patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.
Beschreibung

Abnormality of the gastrointestinal tract | Lacking Able to take medication Oral | Requirement Intravenous Feeding | Surgery Affecting Nutrient absorption | Surgery Affecting Drug absorption

Datentyp

boolean

Alias
UMLS CUI [1]
C4023588
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C4075001
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021910
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C1961155
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0678745
a serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.
Beschreibung

Disease Serious Uncontrolled | Investigational Therapy Impaired | Communicable Disease Impairing Investigational Therapy | Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Dementia Preventing Informed Consent | MENTAL STATUS ALTERED Preventing Informed Consent | Dementia Preventing Protocol Compliance | MENTAL STATUS ALTERED Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0221099
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0949266
UMLS CUI [4]
C0018799
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0018802
UMLS CUI [8]
C0027051
UMLS CUI [9,1]
C0003811
UMLS CUI [9,2]
C0205404
UMLS CUI [10,1]
C0497327
UMLS CUI [10,2]
C1292733
UMLS CUI [10,3]
C0021430
UMLS CUI [11,1]
C0746533
UMLS CUI [11,2]
C1292733
UMLS CUI [11,3]
C0021430
UMLS CUI [12,1]
C0497327
UMLS CUI [12,2]
C1292733
UMLS CUI [12,3]
C0525058
UMLS CUI [13,1]
C0746533
UMLS CUI [13,2]
C1292733
UMLS CUI [13,3]
C0525058
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Ähnliche Modelle

Eligibility Breast Cancer NCT00908791

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Invasive | Breast Carcinoma Resectable TNM Breast tumor staging
Item
all study patients must have histologically confirmed invasive adenocarcinoma of the breast. their breast cancer must be resectable clinical stage i or ii breast cancer as defined by the current ajcc tnm staging system (greene fl, page dl, fleming id, et al.: editors. ajcc cancer staging manual, 6th edition. new york: springer; 2002).
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
Informed Consent
Item
all patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.
boolean
C0021430 (UMLS CUI [1])
Age
Item
all subjects must be age >18 years.
boolean
C0001779 (UMLS CUI [1])
Liver function | Renal function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
all subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (ast or alt) ≤ 1.5 times the upper limits of normal, total bilirubin ≤ 1.5 times the upper limits of normal, serum creatinine ≤
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Creatinine clearance Estimated
Item
1.5 times the upper limit of normal or ecrcl ≥ 60 ml/min.
boolean
C0151280 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure Breast Carcinoma
Item
patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.
boolean
C1522449 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma
Item
patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Female Sterilization | Postmenopausal state | Childbearing Potential Contraceptive methods | Oral contraception | Contraceptive implant | Hormonal contraception Injectable | Intrauterine Devices | Contraception, Barrier | Vaginal contraceptive diaphragm | Female Condoms | Vaginal Spermicides | Sexual Abstinence | Partner had vasectomy | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0029151 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C2985296 (UMLS CUI [6,1])
C0086466 (UMLS CUI [6,2])
C0021900 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
C0042241 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C0087145 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C0420842 (UMLS CUI [13])
C3831118 (UMLS CUI [14,1])
C0430061 (UMLS CUI [14,2])
C3831118 (UMLS CUI [15,1])
C0430057 (UMLS CUI [15,2])
C0032961 (UMLS CUI [16])
C0006147 (UMLS CUI [17])
C3831118 (UMLS CUI [18,1])
C0700589 (UMLS CUI [18,2])
C0332197 (UMLS CUI [18,3])
Abnormality of the gastrointestinal tract | Lacking Able to take medication Oral | Requirement Intravenous Feeding | Surgery Affecting Nutrient absorption | Surgery Affecting Drug absorption
Item
patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.
boolean
C4023588 (UMLS CUI [1])
C0332268 (UMLS CUI [2,1])
C4075001 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0021910 (UMLS CUI [3,2])
C0543467 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C1961155 (UMLS CUI [4,3])
C0543467 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0678745 (UMLS CUI [5,3])
Disease Serious Uncontrolled | Investigational Therapy Impaired | Communicable Disease Impairing Investigational Therapy | Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious | Dementia Preventing Informed Consent | MENTAL STATUS ALTERED Preventing Informed Consent | Dementia Preventing Protocol Compliance | MENTAL STATUS ALTERED Preventing Protocol Compliance
Item
a serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0949266 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4])
C1868885 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0018802 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0003811 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C0497327 (UMLS CUI [10,1])
C1292733 (UMLS CUI [10,2])
C0021430 (UMLS CUI [10,3])
C0746533 (UMLS CUI [11,1])
C1292733 (UMLS CUI [11,2])
C0021430 (UMLS CUI [11,3])
C0497327 (UMLS CUI [12,1])
C1292733 (UMLS CUI [12,2])
C0525058 (UMLS CUI [12,3])
C0746533 (UMLS CUI [13,1])
C1292733 (UMLS CUI [13,2])
C0525058 (UMLS CUI [13,3])
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