ID

19612

Description

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

Keywords

Versions (2)
  1. 1/15/17 1/15/17 -
  2. 1/16/17 1/16/17 -
Uploaded on

January 16, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00429403

English

Eligibility Breast Cancer NCT00429403

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Age

Data type

boolean

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

Breast Carcinoma Primary TNM clinical staging

Data type

boolean

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

Invasive carcinoma of breast

Data type

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).
Description

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

Data type

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:
Description

Premenopausal state | Chemotherapy

Data type

boolean

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

Vaginal Hemorrhage Cyclic

Data type

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.
Description

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

Data type

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.
Description

Neoadjuvant Chemotherapy Breast Carcinoma Primary | Adjuvant Chemotherapy Breast Carcinoma Primary

Data type

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.
Description

Chemotherapy cycle Quantity

Data type

boolean

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

Zubrod Performance Status

Data type

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.
Description

Ovarian function Preservation | Protocol Compliance

Data type

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.
Description

Sexually active Barrier Contraception Willing

Data type

boolean

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

Exclusion Criteria

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

Pregnancy | Gender Pregnancy test negative | Injection of therapeutic agent

Data type

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.
Description

Hypersensitivity GnRH Analog

Data type

boolean

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

Systemic Chemotherapy

Data type

boolean

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

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

Data type

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.
Description

Breast Carcinoma TNM clinical staging

Data type

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
Description

Prothrombin time assay | Partial prothrombin time | International Normalized Ratio

Data type

boolean

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

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
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Similar models

Eligibility Breast Cancer NCT00429403

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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