ID

26013

Beschreibung

Clinical Trial of SAHA in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00416130

Link

https://clinicaltrials.gov/show/NCT00416130

Stichworte

Versionen (2)
  1. 02.10.17 02.10.17 -
  2. 04.10.17 04.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4. Oktober 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Breast Cancer NCT00416130

Englisch

Eligibility Breast Cancer NCT00416130

1 Formulare  
Criteria
Beschreibung

Criteria

cytologically or histologically confirmed adenocarcinoma of the breast that is recurrent and/or metastatic
Beschreibung

Breast adenocarcinoma recurrent | Breast adenocarcinoma metastatic

Datentyp

boolean

Alias
UMLS CUI [1]
C0861355
UMLS CUI [2]
C1697918
must have measurable disease as defined by recist criteria
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
no more than 2 prior chemotherapy for recurrent and/or metastatic disease excluding neoadjuvant or adjuvant chemotherapy
Beschreibung

Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis | Exception Chemotherapy Neoadjuvant | Exception Adjuvant Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0277556
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0085533
previously received anthracycline- and taxane-containing chemotherapy for treatment of breast cancer in the neoadjuvant, adjuvant, or metastatic setting
Beschreibung

Chemotherapy Containing Anthracyclines | Chemotherapy Containing Taxane | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0282564
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0215136
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0678222
UMLS CUI [5]
C0346993
must be able to swallow capsules
Beschreibung

Able to swallow capsules

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
adequate bone marrow reserve and liver function
Beschreibung

Mature Neutrophils Present Bone Marrow Complete | Liver function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0232741
women in reproductive age group must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
Beschreibung

Childbearing Potential Contraceptive methods | Exception Documentation Infertility

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0175636
UMLS CUI [2,3]
C0021359
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
prior treatment with any hdac inhibitor. patients who have received such agents for other indications, e.g. epilepsy, may enroll in the trial after a 30 day washout period.
Beschreibung

Histone deacetylase inhibitor | Histone deacetylase inhibitor Epilepsy allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C1512474
UMLS CUI [2,1]
C1512474
UMLS CUI [2,2]
C0014544
UMLS CUI [2,3]
C0683607
known cns involvement by tumor
Beschreibung

Central Nervous System Involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C4050309
concurrent use of oral retinoids or any vitamin a, other than a single multivitamin tablet daily
Beschreibung

Retinoids Oral | Vitamin A | Exception Daily Multivitamin Oral Tablet

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0035339
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0042839
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0976064
acute infection requiring intravenous antibiotics or antifungal agents,known hiv infection, active hepatitis b and/or hepatitis c infection
Beschreibung

Communicable Disease Requirement Intravenous antibiotic therapy | Communicable Disease Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003308
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0019196
uncontrolled intercurrent illness
Beschreibung

Comorbidity Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
cancer other than breast cancer with the exception of basal cell carcinoma or disease that has been in remission for ≥5 years
Beschreibung

Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma | Exception Disease remission Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0544452
UMLS CUI [4,3]
C0449238
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Breast Cancer NCT00416130

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Breast adenocarcinoma recurrent | Breast adenocarcinoma metastatic
Item
cytologically or histologically confirmed adenocarcinoma of the breast that is recurrent and/or metastatic
boolean
C0861355 (UMLS CUI [1])
C1697918 (UMLS CUI [2])
Measurable Disease
Item
must have measurable disease as defined by recist criteria
boolean
C1513041 (UMLS CUI [1])
Chemotherapy Quantity Recurrent disease | Chemotherapy Quantity Neoplasm Metastasis | Exception Chemotherapy Neoadjuvant | Exception Adjuvant Chemotherapy
Item
no more than 2 prior chemotherapy for recurrent and/or metastatic disease excluding neoadjuvant or adjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0085533 (UMLS CUI [4,2])
Chemotherapy Containing Anthracyclines | Chemotherapy Containing Taxane | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | Secondary malignant neoplasm of female breast
Item
previously received anthracycline- and taxane-containing chemotherapy for treatment of breast cancer in the neoadjuvant, adjuvant, or metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0282564 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0215136 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C0346993 (UMLS CUI [5])
Able to swallow capsules
Item
must be able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Mature Neutrophils Present Bone Marrow Complete | Liver function
Item
adequate bone marrow reserve and liver function
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Exception Documentation Infertility
Item
women in reproductive age group must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0175636 (UMLS CUI [2,2])
C0021359 (UMLS CUI [2,3])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Histone deacetylase inhibitor | Histone deacetylase inhibitor Epilepsy allowed
Item
prior treatment with any hdac inhibitor. patients who have received such agents for other indications, e.g. epilepsy, may enroll in the trial after a 30 day washout period.
boolean
C1512474 (UMLS CUI [1])
C1512474 (UMLS CUI [2,1])
C0014544 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
Central Nervous System Involvement
Item
known cns involvement by tumor
boolean
C4050309 (UMLS CUI [1])
Retinoids Oral | Vitamin A | Exception Daily Multivitamin Oral Tablet
Item
concurrent use of oral retinoids or any vitamin a, other than a single multivitamin tablet daily
boolean
C0035339 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0042839 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0976064 (UMLS CUI [3,2])
Communicable Disease Requirement Intravenous antibiotic therapy | Communicable Disease Requirement Antifungal Agents | HIV Infection | Hepatitis B | Hepatitis C
Item
acute infection requiring intravenous antibiotics or antifungal agents,known hiv infection, active hepatitis b and/or hepatitis c infection
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003308 (UMLS CUI [2,3])
C0019693 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0019196 (UMLS CUI [5])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Basal cell carcinoma | Exception Disease remission Duration
Item
cancer other than breast cancer with the exception of basal cell carcinoma or disease that has been in remission for ≥5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0544452 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video