ID

44180

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02344940

Nyckelord

Versioner (2)
  1. 2019-02-08 2019-02-08 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02344940

Engelsk

Eligibility Breast Cancer NCT02344940

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Gender | Age | Premenopausal state

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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;
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Hormone Receptor Negative

Datatyp

boolean

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

Hormone Therapy Neoadjuvant | Hormone Therapy Adjuvant

Datatyp

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.
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

OVARIAN ABNORMALITY Transvaginal echography | Endometrial thickening Transvaginal echography

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Ovarian suppression

Datatyp

boolean

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

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

Datatyp

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.
Beskrivning

Liver Dysfunction Severe Child-Pugh Classification

Datatyp

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.
Beskrivning

Cardiac dysfunction Severe New York Heart Association Classification

Datatyp

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;
Beskrivning

Severe allergy Investigational New Drugs

Datatyp

boolean

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

Eligibility Breast Cancer NCT02344940

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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