ID

34890

Beschrijving

High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01646034

Link

https://clinicaltrials.gov/show/NCT01646034

Trefwoorden

Versies (1)
  1. 03-02-19 03-02-19 -
Houder van rechten

See clinicaltrials.gov

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3 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01646034

Engels

Eligibility Breast Cancer NCT01646034

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed infiltrating breast cancer
Beschrijving

Invasive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
oligometastatic disease defined as one to three metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the axillary, parasternal, and ipsilateral periclavicular regions. all lesions must be amenable to resection or radiotherapy with curative intent. staging examinations must have included a pet-scan plus diagnostic ct-scan of the chest and abdomen, and an isotope bone scan. when the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, mri or ct-scan of the affected skeletal region must be performed.
Beschrijving

Neoplasm Metastasis Few | Metastatic Lesion Quantity | Primary tumor | Primary tumor Absent | Neoplasm Recurrence, Local | Secondary malignant neoplasm of lymph node Local-Regional | Axillary region | Parasternal region | Other Coding | Lesion Amenable Excision Curative | Lesion Amenable Therapeutic radiology procedure Curative | Staging Chest PET with concurrent CT | Staging PET/CT scan Abdomen | Staging Radioisotope scan of bone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205388
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0677930
UMLS CUI [4,1]
C0677930
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0027643
UMLS CUI [6,1]
C0686619
UMLS CUI [6,2]
C1947913
UMLS CUI [7]
C0004454
UMLS CUI [8]
C0458345
UMLS CUI [9]
C3846158
UMLS CUI [10,1]
C0221198
UMLS CUI [10,2]
C3900053
UMLS CUI [10,3]
C0728940
UMLS CUI [10,4]
C1276305
UMLS CUI [11,1]
C0221198
UMLS CUI [11,2]
C3900053
UMLS CUI [11,3]
C1522449
UMLS CUI [11,4]
C1276305
UMLS CUI [12,1]
C0332305
UMLS CUI [12,2]
C2073389
UMLS CUI [13,1]
C0332305
UMLS CUI [13,2]
C1699633
UMLS CUI [13,3]
C0000726
UMLS CUI [14,1]
C0332305
UMLS CUI [14,2]
C0203668
the tumor must be her2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry).
Beschrijving

HER2 negative carcinoma of breast Immunohistochemistry | HER2 negative carcinoma of breast In Situ Hybridization

Datatype

boolean

Alias
UMLS CUI [1,1]
C2316304
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C2316304
UMLS CUI [2,2]
C0162788
the tumor must be er positive (≥ 10% nuclear staining at ihc) and poorly differentiated (grade 3).
Beschrijving

Neoplasm Estrogen receptor positive Immunohistochemistry | Poorly differentiated carcinoma Grade

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0741899
UMLS CUI [2,2]
C0441800
or er negative; the rare tumors that are er-negative and pgr-positive will be eligible, if this pattern of hormone receptor expression can be verified in the nki-avl reference pathology lab.
Beschrijving

Neoplasm Estrogen receptor negative | Neoplasm Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0279759
known brca1 or brca2 mutation carriers are eligible regardless of the estrogen receptor status of their tumor.
Beschrijving

BRCA1 gene mutation | BRCA2 gene mutation

Datatype

boolean

Alias
UMLS CUI [1]
C1511022
UMLS CUI [2]
C1511024
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
world health organisation (who) performance status 0 or 1
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
adequate bone marrow function (anc ≥ 1.0 x 109/l, platelets ≥ 100 x 109/l)
Beschrijving

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
adequate hepatic function (alat, asat and bilirubin ≤ 2.5 times upper limit of normal)
Beschrijving

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
adequate renal function (creatinine clearance ≥ 60 ml/min)
Beschrijving

Renal function | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
lvef ≥ 50% measured by echocardiography or muga
Beschrijving

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Multiple gated acquisition scanning

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beschrijving

Absence Condition Interferes with Protocol Compliance | Interference Mental conditions Absent | Interference Factor Familial Absent | Interference Sociological Factors Absent | Interference Geographic Factors Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0809986
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C1521761
UMLS CUI [3,3]
C0241888
UMLS CUI [3,4]
C0332197
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C3850138
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C0017444
UMLS CUI [5,3]
C0332197
signed written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to comply with the protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy
Beschrijving

Cancer Other | Exception Curative treatment Malignant Neoplasms | Exception Curative treatment Without Chemotherapy | Exception Curative treatment Without Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C0392920
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0332288
UMLS CUI [4,4]
C1522449
no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
no concurrent anti-cancer treatment or investigational drugs
Beschrijving

Cancer treatment | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
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Similar models

Eligibility Breast Cancer NCT01646034

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically or cytologically confirmed infiltrating breast cancer
boolean
C0853879 (UMLS CUI [1])
Neoplasm Metastasis Few | Metastatic Lesion Quantity | Primary tumor | Primary tumor Absent | Neoplasm Recurrence, Local | Secondary malignant neoplasm of lymph node Local-Regional | Axillary region | Parasternal region | Other Coding | Lesion Amenable Excision Curative | Lesion Amenable Therapeutic radiology procedure Curative | Staging Chest PET with concurrent CT | Staging PET/CT scan Abdomen | Staging Radioisotope scan of bone
Item
oligometastatic disease defined as one to three metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the axillary, parasternal, and ipsilateral periclavicular regions. all lesions must be amenable to resection or radiotherapy with curative intent. staging examinations must have included a pet-scan plus diagnostic ct-scan of the chest and abdomen, and an isotope bone scan. when the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, mri or ct-scan of the affected skeletal region must be performed.
boolean
C0027627 (UMLS CUI [1,1])
C0205388 (UMLS CUI [1,2])
C1513183 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677930 (UMLS CUI [3])
C0677930 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0027643 (UMLS CUI [5])
C0686619 (UMLS CUI [6,1])
C1947913 (UMLS CUI [6,2])
C0004454 (UMLS CUI [7])
C0458345 (UMLS CUI [8])
C3846158 (UMLS CUI [9])
C0221198 (UMLS CUI [10,1])
C3900053 (UMLS CUI [10,2])
C0728940 (UMLS CUI [10,3])
C1276305 (UMLS CUI [10,4])
C0221198 (UMLS CUI [11,1])
C3900053 (UMLS CUI [11,2])
C1522449 (UMLS CUI [11,3])
C1276305 (UMLS CUI [11,4])
C0332305 (UMLS CUI [12,1])
C2073389 (UMLS CUI [12,2])
C0332305 (UMLS CUI [13,1])
C1699633 (UMLS CUI [13,2])
C0000726 (UMLS CUI [13,3])
C0332305 (UMLS CUI [14,1])
C0203668 (UMLS CUI [14,2])
HER2 negative carcinoma of breast Immunohistochemistry | HER2 negative carcinoma of breast In Situ Hybridization
Item
the tumor must be her2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry).
boolean
C2316304 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C2316304 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
Neoplasm Estrogen receptor positive Immunohistochemistry | Poorly differentiated carcinoma Grade
Item
the tumor must be er positive (≥ 10% nuclear staining at ihc) and poorly differentiated (grade 3).
boolean
C0027651 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0741899 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
Neoplasm Estrogen receptor negative | Neoplasm Progesterone receptor positive
Item
or er negative; the rare tumors that are er-negative and pgr-positive will be eligible, if this pattern of hormone receptor expression can be verified in the nki-avl reference pathology lab.
boolean
C0027651 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
BRCA1 gene mutation | BRCA2 gene mutation
Item
known brca1 or brca2 mutation carriers are eligible regardless of the estrogen receptor status of their tumor.
boolean
C1511022 (UMLS CUI [1])
C1511024 (UMLS CUI [2])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
world health organisation (who) performance status 0 or 1
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function (anc ≥ 1.0 x 109/l, platelets ≥ 100 x 109/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
adequate hepatic function (alat, asat and bilirubin ≤ 2.5 times upper limit of normal)
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine clearance measurement
Item
adequate renal function (creatinine clearance ≥ 60 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction Multiple gated acquisition scanning
Item
lvef ≥ 50% measured by echocardiography or muga
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Absence Condition Interferes with Protocol Compliance | Interference Mental conditions Absent | Interference Factor Familial Absent | Interference Sociological Factors Absent | Interference Geographic Factors Absent
Item
absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0332197 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0521102 (UMLS CUI [2,1])
C0809986 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C1521761 (UMLS CUI [3,2])
C0241888 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0521102 (UMLS CUI [4,1])
C3850138 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0521102 (UMLS CUI [5,1])
C0017444 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
able to comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception Curative treatment Malignant Neoplasms | Exception Curative treatment Without Chemotherapy | Exception Curative treatment Without Therapeutic radiology procedure
Item
no malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C0392920 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0332288 (UMLS CUI [4,3])
C1522449 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer treatment | Investigational New Drugs
Item
no concurrent anti-cancer treatment or investigational drugs
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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