ID

19612

Descrição

Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00429403

Link

https://clinicaltrials.gov/show/NCT00429403

Palavras-chave

Versões (2)
  1. 15/01/2017 15/01/2017 -
  2. 16/01/2017 16/01/2017 -
Transferido a

16 de janeiro de 2017

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00429403

Inglês

Eligibility Breast Cancer NCT00429403

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female patients older than 15 years and younger than 46 years.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. primary breast cancer (stage i, ii, or iii).
Descrição

Breast Carcinoma Primary TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C3258246
3. pathologically confirmed invasive breast carcinoma.
Descrição

Invasive carcinoma of breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0853879
4. negative hormone-receptor status. (negative defined as er- and pr- staining in less than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein on ligand-binding or enzyme-linked immunoassay).
Descrição

Hormone Receptor Status Negative | Estrogen Receptor Staining Method Negative for tumor cells | Progesterone Receptor Staining Method Negative for tumor cells | Malignant Neoplasms Cytosol Ligand Binding Immunoassay | Malignant Neoplasms Cytosol Enzyme-Linked Immunosorbent Assay

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C1513916
UMLS CUI [2,1]
C4055053
UMLS CUI [2,2]
C0332654
UMLS CUI [3,1]
C4054151
UMLS CUI [3,2]
C0332654
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C1383501
UMLS CUI [4,3]
C1517880
UMLS CUI [4,4]
C0020980
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C1383501
UMLS CUI [5,3]
C0014441
5. premenopausal, verified before chemotherapy is begun as satisfying both:
Descrição

Premenopausal state | Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0392920
cyclic vaginal bleeding.
Descrição

Vaginal Hemorrhage Cyclic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2979982
UMLS CUI [1,2]
C0439596
follicle-stimulating hormone (fsh) is less than or equal to 15 iu/l. if patients are taking oral contraceptives, fsh must be measured 1-2 weeks after discontinuation. if fsh is greater than 15 and the patient has regular menses, gynecologic consultation will be required for a decision on premenopausal status.
Descrição

Follicle stimulating hormone measurement | Contraceptives, Oral | Normal menstruation | Premenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202022
UMLS CUI [2]
C0009905
UMLS CUI [3]
C0559892
UMLS CUI [4]
C0232969
6. candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
Descrição

Neoadjuvant Chemotherapy Breast Carcinoma Primary | Adjuvant Chemotherapy Breast Carcinoma Primary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0678222
UMLS CUI [1,4]
C0205225
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0205225
7. treatment with at least four (4) cycles of chemotherapy as planned.
Descrição

Chemotherapy cycle Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
8. zubrod performance score of 0 or 1.
Descrição

Zubrod Performance Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3714786
9. must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
Descrição

Ovarian function Preservation | Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678879
UMLS CUI [1,2]
C1514402
UMLS CUI [2]
C0525058
10. willingness to use barrier contraception if sexually active.
Descrição

Sexually active Barrier Contraception Willing

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0241028
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0600109
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnancy. women must have a negative serum pregnancy test before initiation of injection.
Descrição

Pregnancy | Gender Pregnancy test negative | Injection of therapeutic agent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0427780
UMLS CUI [3]
C0021485
2. hypersensitivity to any gnrh analog.
Descrição

Hypersensitivity GnRH Analog

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1518041
3. previous receipt of systemic chemotherapy.
Descrição

Systemic Chemotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1883256
4. to receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with cmf.
Descrição

cyclophosphamide/fluorouracil/methotrexate Chemotherapy cycle Quantity Neoadjuvant | cyclophosphamide/fluorouracil/methotrexate Chemotherapy cycle Quantity Adjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0950521
UMLS CUI [1,2]
C1302181
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0600558
UMLS CUI [2,1]
C0950521
UMLS CUI [2,2]
C1302181
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1522673
5. stage iv breast cancer.
Descrição

Breast Carcinoma TNM clinical staging

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C3258246
6. prothrombin time (pt) and partial prothrombin time (ptt) with inr > 1.5
Descrição

Prothrombin time assay | Partial prothrombin time | International Normalized Ratio

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0853653
UMLS CUI [3]
C0525032
7. platelets < 50,000/mm^3
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
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Similar models

Eligibility Breast Cancer NCT00429403

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. female patients older than 15 years and younger than 46 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma Primary TNM clinical staging
Item
2. primary breast cancer (stage i, ii, or iii).
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
Invasive carcinoma of breast
Item
3. pathologically confirmed invasive breast carcinoma.
boolean
C0853879 (UMLS CUI [1])
Hormone Receptor Status Negative | Estrogen Receptor Staining Method Negative for tumor cells | Progesterone Receptor Staining Method Negative for tumor cells | Malignant Neoplasms Cytosol Ligand Binding Immunoassay | Malignant Neoplasms Cytosol Enzyme-Linked Immunosorbent Assay
Item
4. negative hormone-receptor status. (negative defined as er- and pr- staining in less than 10% of tumor cells, or tumors with less than or equal to 3 fm/mg cytosol protein on ligand-binding or enzyme-linked immunoassay).
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
C4055053 (UMLS CUI [2,1])
C0332654 (UMLS CUI [2,2])
C4054151 (UMLS CUI [3,1])
C0332654 (UMLS CUI [3,2])
C0006826 (UMLS CUI [4,1])
C1383501 (UMLS CUI [4,2])
C1517880 (UMLS CUI [4,3])
C0020980 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C1383501 (UMLS CUI [5,2])
C0014441 (UMLS CUI [5,3])
Premenopausal state | Chemotherapy
Item
5. premenopausal, verified before chemotherapy is begun as satisfying both:
boolean
C0232969 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Vaginal Hemorrhage Cyclic
Item
cyclic vaginal bleeding.
boolean
C2979982 (UMLS CUI [1,1])
C0439596 (UMLS CUI [1,2])
Follicle stimulating hormone measurement | Contraceptives, Oral | Normal menstruation | Premenopausal state
Item
follicle-stimulating hormone (fsh) is less than or equal to 15 iu/l. if patients are taking oral contraceptives, fsh must be measured 1-2 weeks after discontinuation. if fsh is greater than 15 and the patient has regular menses, gynecologic consultation will be required for a decision on premenopausal status.
boolean
C0202022 (UMLS CUI [1])
C0009905 (UMLS CUI [2])
C0559892 (UMLS CUI [3])
C0232969 (UMLS CUI [4])
Neoadjuvant Chemotherapy Breast Carcinoma Primary | Adjuvant Chemotherapy Breast Carcinoma Primary
Item
6. candidates for neoadjuvant and/or adjuvant chemotherapy for primary breast cancer.
boolean
C0600558 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C0085533 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0205225 (UMLS CUI [2,3])
Chemotherapy cycle Quantity
Item
7. treatment with at least four (4) cycles of chemotherapy as planned.
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Zubrod Performance Status
Item
8. zubrod performance score of 0 or 1.
boolean
C3714786 (UMLS CUI [1])
Ovarian function Preservation | Protocol Compliance
Item
9. must consent to preservation of their ovarian function and indicate their awareness of the investigational nature of this study, in keeping with institutional policy.
boolean
C0678879 (UMLS CUI [1,1])
C1514402 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Sexually active Barrier Contraception Willing
Item
10. willingness to use barrier contraception if sexually active.
boolean
C0241028 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Gender Pregnancy test negative | Injection of therapeutic agent
Item
1. pregnancy. women must have a negative serum pregnancy test before initiation of injection.
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0021485 (UMLS CUI [3])
Hypersensitivity GnRH Analog
Item
2. hypersensitivity to any gnrh analog.
boolean
C0020517 (UMLS CUI [1,1])
C1518041 (UMLS CUI [1,2])
Systemic Chemotherapy
Item
3. previous receipt of systemic chemotherapy.
boolean
C1883256 (UMLS CUI [1])
cyclophosphamide/fluorouracil/methotrexate Chemotherapy cycle Quantity Neoadjuvant | cyclophosphamide/fluorouracil/methotrexate Chemotherapy cycle Quantity Adjuvant
Item
4. to receive at least 4 cycles of neoadjuvant and/or adjuvant chemotherapy with cmf.
boolean
C0950521 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0600558 (UMLS CUI [1,4])
C0950521 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1522673 (UMLS CUI [2,4])
Breast Carcinoma TNM clinical staging
Item
5. stage iv breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prothrombin time assay | Partial prothrombin time | International Normalized Ratio
Item
6. prothrombin time (pt) and partial prothrombin time (ptt) with inr > 1.5
boolean
C0033707 (UMLS CUI [1])
C0853653 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
Platelet Count measurement
Item
7. platelets < 50,000/mm^3
boolean
C0032181 (UMLS CUI [1])
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