ID

38045

Beskrivning

Predictors of Response to Neoadjuvant Docetaxel-Carboplatin Chemotherapy for Patients With Stage II and III Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01560663

Länk

https://clinicaltrials.gov/show/NCT01560663

Nyckelord

Versioner (1)
  1. 2019-09-11 2019-09-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01560663

Engelsk

Eligibility Breast Cancer NCT01560663

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent form signed by the patient to accept study enrollment.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
female with pathologically confirmed diagnosis of primary invasive operable breast cancer, stage iia-iiic (6th edition of the ajcc cancer staging manual), with tumors ≥
Beskrivning

Gender | Invasive carcinoma of breast Operable TNM Breast tumor staging

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205188
UMLS CUI [2,3]
C0474926
2cm.
Beskrivning

Tumor size

Datatyp

boolean

Alias
UMLS CUI [1]
C0475440
triple negative phenotype patients (re and pr of less than 1% of stained cells by ihq, ihc for her2 of 0-1+ or ish negative if 2/3+), according to local laboratory.
Beskrivning

Triple Negative Breast Neoplasm | Estrogen Receptor Measurement Immunohistochemistry | Progesterone Receptor Measurement Immunohistochemistry | HER2 Immunohistochemistry | HER2 ISH Negative

Datatyp

boolean

Alias
UMLS CUI [1]
C3539878
UMLS CUI [2,1]
C3811131
UMLS CUI [2,2]
C0021044
UMLS CUI [3,1]
C3889640
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C0021044
UMLS CUI [5,1]
C0069515
UMLS CUI [5,2]
C3853647
UMLS CUI [5,3]
C1513916
age 18-75 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
adequate performance status (ecog <2).
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate renal and liver function and bone marrow reserve.
Beskrivning

Renal function | Liver function | Bone Marrow Mature Neutrophils Present

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
UMLS CUI [3,1]
C0005953
UMLS CUI [3,2]
C1708947
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinical or radiologic evidence of metastatic disease.
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy).
Beskrivning

Cancer treatment Disease Current | Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0521116
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0021083
prior therapy with taxanes, anthracyclines or carboplatin for any malignancy.
Beskrivning

Cancer treatment Previous | taxane | Anthracyclines | Carboplatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0215136
UMLS CUI [3]
C0282564
UMLS CUI [4]
C0079083
contraindication for study drugs (docetaxel or carboplatin).
Beskrivning

Medical contraindication Investigational New Drugs | Medical contraindication Docetaxel | Medical contraindication Carboplatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0246415
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0079083
serious concomitant systemic disorder that in the opinion of the investigator would compromise the patient's ability to complete the study, or have any other disease that could be worsened by chemotherapy or other potential support therapies.
Beskrivning

Comorbidity Systemic Serious | Comorbidity compromises Completion of clinical trial | Disease Worsening Due to Chemotherapy | Disease Worsening Due to Adjuvant therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0332271
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0392920
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0332271
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0677850
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Similar models

Eligibility Breast Cancer NCT01560663

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent form signed by the patient to accept study enrollment.
boolean
C0021430 (UMLS CUI [1])
Gender | Invasive carcinoma of breast Operable TNM Breast tumor staging
Item
female with pathologically confirmed diagnosis of primary invasive operable breast cancer, stage iia-iiic (6th edition of the ajcc cancer staging manual), with tumors ≥
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0205188 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
Tumor size
Item
2cm.
boolean
C0475440 (UMLS CUI [1])
Triple Negative Breast Neoplasm | Estrogen Receptor Measurement Immunohistochemistry | Progesterone Receptor Measurement Immunohistochemistry | HER2 Immunohistochemistry | HER2 ISH Negative
Item
triple negative phenotype patients (re and pr of less than 1% of stained cells by ihq, ihc for her2 of 0-1+ or ish negative if 2/3+), according to local laboratory.
boolean
C3539878 (UMLS CUI [1])
C3811131 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C3889640 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0069515 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C0069515 (UMLS CUI [5,1])
C3853647 (UMLS CUI [5,2])
C1513916 (UMLS CUI [5,3])
Age
Item
age 18-75 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
adequate performance status (ecog <2).
boolean
C1520224 (UMLS CUI [1])
Renal function | Liver function | Bone Marrow Mature Neutrophils Present
Item
adequate renal and liver function and bone marrow reserve.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C1708947 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
clinical or radiologic evidence of metastatic disease.
boolean
C0027627 (UMLS CUI [1])
Cancer treatment Disease Current | Hormone Therapy | Chemotherapy | Therapeutic radiology procedure | Immunotherapy
Item
prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy).
boolean
C0920425 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
Cancer treatment Previous | taxane | Anthracyclines | Carboplatin
Item
prior therapy with taxanes, anthracyclines or carboplatin for any malignancy.
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0215136 (UMLS CUI [2])
C0282564 (UMLS CUI [3])
C0079083 (UMLS CUI [4])
Medical contraindication Investigational New Drugs | Medical contraindication Docetaxel | Medical contraindication Carboplatin
Item
contraindication for study drugs (docetaxel or carboplatin).
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0246415 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0079083 (UMLS CUI [3,2])
Comorbidity Systemic Serious | Comorbidity compromises Completion of clinical trial | Disease Worsening Due to Chemotherapy | Disease Worsening Due to Adjuvant therapy
Item
serious concomitant systemic disorder that in the opinion of the investigator would compromise the patient's ability to complete the study, or have any other disease that could be worsened by chemotherapy or other potential support therapies.
boolean
C0009488 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0332271 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C0332271 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0677850 (UMLS CUI [4,4])
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