ID

44180

Descrição

Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02344940

Link

https://clinicaltrials.gov/show/NCT02344940

Palavras-chave

Versões (2)
  1. 08/02/2019 08/02/2019 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02344940

Inglês

Eligibility Breast Cancer NCT02344940

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women aged ≥18 years, premenopausal
Descrição

Gender | Age | Premenopausal state

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232969
2. histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(er)/progesterone receptor(pr) positive
Descrição

Invasive carcinoma of breast Core needle biopsy | Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0279754
UMLS CUI [4]
C0279759
3. patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
Descrição

Standard therapy | Modified radical mastectomy Normalized | Breast-Conserving Surgery | Negative Surgical Margin | Postoperative course of radiotherapy | Adjuvant therapy Completed | Radiotherapy, Adjuvant | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2936643
UMLS CUI [2,1]
C0024883
UMLS CUI [2,2]
C1882115
UMLS CUI [3]
C0917927
UMLS CUI [4]
C1709157
UMLS CUI [5]
C0436206
UMLS CUI [6,1]
C0677850
UMLS CUI [6,2]
C0205197
UMLS CUI [7]
C0242939
UMLS CUI [8,1]
C0392920
UMLS CUI [8,2]
C0600558
UMLS CUI [9]
C0085533
4. leukocyte ≥ 3*109/l; platelets ≥ 75*109/l; serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal (unl) range serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range; written informed consent according to the local ethics committee requirements.
Descrição

White Blood Cell Count procedure | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Blood urea nitrogen measurement | Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201976
UMLS CUI [6]
C0005845
UMLS CUI [7]
C0021430
5. has eastern cooperative oncology group(ecog) performance score 0-2;
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. histologically confirmed hormonal receptor negative.
Descrição

Hormone Receptor Negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1513916
2. have received neoadjuvant/adjuvant endocrine therapy.
Descrição

Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1522673
3. with metastatic tumor.
Descrição

Neoplasm Metastasis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
4. family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
Descrição

Family history Endometrial Carcinoma | FH: Ovarian carcinoma | Family history Gynecologic neoplasm

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0476089
UMLS CUI [2]
C0559120
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C0017416
5. have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
Descrição

OVARIAN ABNORMALITY Transvaginal echography | Endometrial thickening Transvaginal echography

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0149747
UMLS CUI [1,2]
C0203418
UMLS CUI [2,1]
C0743516
UMLS CUI [2,2]
C0203418
6. with any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
Descrição

Female sex hormone level Increased by Complication | Pituitary Adenoma | Ovarian neoplasm | Malignant neoplasm of thymus

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3495860
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0009566
UMLS CUI [2]
C0032000
UMLS CUI [3]
C0919267
UMLS CUI [4]
C0751552
7. with any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc.
Descrição

Female sex hormone level Decreased by Complication | Hyperthyroidism | Hypothyroidism | Liver Cirrhosis | Severe malnutrition | Turner Syndrome | Female sex hormones Synthetase Deficiency | Neoplasms, Intracranial | Atrophy of the pituitary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3495860
UMLS CUI [1,2]
C0205216
UMLS CUI [1,3]
C0009566
UMLS CUI [2]
C0020550
UMLS CUI [3]
C0020676
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0311276
UMLS CUI [6]
C0041408
UMLS CUI [7,1]
C1287361
UMLS CUI [7,2]
C4522002
UMLS CUI [7,3]
C0011155
UMLS CUI [8]
C1527390
UMLS CUI [9]
C4014943
8. ovarian ablation or suppression
Descrição

Ovarian suppression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0677922
9. with severe non-malignant co-morbidity that will influence long-term follow up.
Descrição

Comorbidity Severe Influence Long-term Follow-up | Exception Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4054723
UMLS CUI [1,4]
C1517942
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
10. with severe hepatic dysfunction, child-pugh c.
Descrição

Liver Dysfunction Severe Child-Pugh Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4050412
11. with severe cardiac dysfunction, new york heart association (nyha) grading iii or worse.
Descrição

Cardiac dysfunction Severe New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3277906
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1275491
12. known severe hypersensitivity to any drugs in this study;
Descrição

Severe allergy Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Breast Cancer NCT02344940

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Premenopausal state
Item
1. women aged ≥18 years, premenopausal
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232969 (UMLS CUI [3])
Invasive carcinoma of breast Core needle biopsy | Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive
Item
2. histologically confirmed invasive breast cancer by core needle biopsy, hormonal receptor positive, defined as estrogen receptor(er)/progesterone receptor(pr) positive
boolean
C0853879 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0019929 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0279754 (UMLS CUI [3])
C0279759 (UMLS CUI [4])
Standard therapy | Modified radical mastectomy Normalized | Breast-Conserving Surgery | Negative Surgical Margin | Postoperative course of radiotherapy | Adjuvant therapy Completed | Radiotherapy, Adjuvant | Chemotherapy Neoadjuvant | Chemotherapy, Adjuvant
Item
3. patients must have received standard local therapy: normalized modified radical mastectomy or breast conserving surgery with negative margin and post-surgical radiotherapy. patient should completed adjuvant therapy according to conditions, including adjuvant radiotherapy, neoadjuvant or adjuvant chemotherapy.
boolean
C2936643 (UMLS CUI [1])
C0024883 (UMLS CUI [2,1])
C1882115 (UMLS CUI [2,2])
C0917927 (UMLS CUI [3])
C1709157 (UMLS CUI [4])
C0436206 (UMLS CUI [5])
C0677850 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C0242939 (UMLS CUI [7])
C0392920 (UMLS CUI [8,1])
C0600558 (UMLS CUI [8,2])
C0085533 (UMLS CUI [9])
White Blood Cell Count procedure | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Blood urea nitrogen measurement | Informed Consent
Item
4. leukocyte ≥ 3*109/l; platelets ≥ 75*109/l; serum glutamate oxaloacetate(ast/sgot) or serum glutamic-pyruvic transaminase(alt/sgpt) <2.5 times of upper limit of normal (unl) range serum creatinine/blood urea nitrogen(bun) ≤ upper limit of normal (unl) range; written informed consent according to the local ethics committee requirements.
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
C0005845 (UMLS CUI [6])
C0021430 (UMLS CUI [7])
ECOG performance status
Item
5. has eastern cooperative oncology group(ecog) performance score 0-2;
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Receptor Negative
Item
1. histologically confirmed hormonal receptor negative.
boolean
C0019929 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant
Item
2. have received neoadjuvant/adjuvant endocrine therapy.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
Neoplasm Metastasis
Item
3. with metastatic tumor.
boolean
C0027627 (UMLS CUI [1])
Family history Endometrial Carcinoma | FH: Ovarian carcinoma | Family history Gynecologic neoplasm
Item
4. family history of endometrial cancer or ovarian cancer or any other kind of gynecological malignant tumor.
boolean
C0241889 (UMLS CUI [1,1])
C0476089 (UMLS CUI [1,2])
C0559120 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0241889 (UMLS CUI [4,1])
C0017416 (UMLS CUI [4,2])
OVARIAN ABNORMALITY Transvaginal echography | Endometrial thickening Transvaginal echography
Item
5. have already been detected of ovarian abnormality or endometrial thickening by transvaginal ultrasound.
boolean
C0149747 (UMLS CUI [1,1])
C0203418 (UMLS CUI [1,2])
C0743516 (UMLS CUI [2,1])
C0203418 (UMLS CUI [2,2])
Female sex hormone level Increased by Complication | Pituitary Adenoma | Ovarian neoplasm | Malignant neoplasm of thymus
Item
6. with any of complications that will increase sex hormone level: pituitary adenoma，ovarian tumor, thymic cancer，etc.
boolean
C3495860 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0032000 (UMLS CUI [2])
C0919267 (UMLS CUI [3])
C0751552 (UMLS CUI [4])
Female sex hormone level Decreased by Complication | Hyperthyroidism | Hypothyroidism | Liver Cirrhosis | Severe malnutrition | Turner Syndrome | Female sex hormones Synthetase Deficiency | Neoplasms, Intracranial | Atrophy of the pituitary
Item
7. with any of complications that will decrease sex hormone level:hyperthyroidism，hypothyroidism，liver cirrhosis，severe malnutrition，turner's syndrome，sex hormone synthetase deficiency, intracranial tumor, pituitary atrophy, etc.
boolean
C3495860 (UMLS CUI [1,1])
C0205216 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C0020550 (UMLS CUI [2])
C0020676 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0311276 (UMLS CUI [5])
C0041408 (UMLS CUI [6])
C1287361 (UMLS CUI [7,1])
C4522002 (UMLS CUI [7,2])
C0011155 (UMLS CUI [7,3])
C1527390 (UMLS CUI [8])
C4014943 (UMLS CUI [9])
Ovarian suppression
Item
8. ovarian ablation or suppression
boolean
C0677922 (UMLS CUI [1])
Comorbidity Severe Influence Long-term Follow-up | Exception Malignant Neoplasms
Item
9. with severe non-malignant co-morbidity that will influence long-term follow up.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4054723 (UMLS CUI [1,3])
C1517942 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
Liver Dysfunction Severe Child-Pugh Classification
Item
10. with severe hepatic dysfunction, child-pugh c.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
Cardiac dysfunction Severe New York Heart Association Classification
Item
11. with severe cardiac dysfunction, new york heart association (nyha) grading iii or worse.
boolean
C3277906 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Severe allergy Investigational New Drugs
Item
12. known severe hypersensitivity to any drugs in this study;
boolean
C2945656 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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