ID

34963

Beschrijving

TRIal evalUating the Menstrual and Ovarian Function of Young Breast Cancer Patients Treated With a cycloPHosphamide-free Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT02053597

Link

https://clinicaltrials.gov/show/NCT02053597

Trefwoorden

Versies (1)
  1. 06-02-19 06-02-19 -
Houder van rechten

See clinicaltrials.gov

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6 februari 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02053597

Engels

Eligibility Breast Cancer NCT02053597

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≤ 40 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. eastern cooperative oncology group (ecog) performance status ≤ 1.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
3. non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
Beschrijving

Invasive carcinoma of breast Primary | Eligibility Adjuvant Chemotherapy | Eligibility Chemotherapy Neoadjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0085533
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0600558
4. negative estrogen (er) and progesterone receptor (pgr) status.
Beschrijving

Estrogen receptor negative status | Progesterone Receptor Status Negative

Datatype

boolean

Alias
UMLS CUI [1]
C1719707
UMLS CUI [2,1]
C1514471
UMLS CUI [2,2]
C1513916
5. baseline left ventricular ejection fraction (lvef) ≥50% measured by an echocardiogram or muga.
Beschrijving

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
6. interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
Beschrijving

Interest Maintenance Function Menstrual | Interest Maintenance Ovarian function | Status post Chemotherapy Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543488
UMLS CUI [1,2]
C0024501
UMLS CUI [1,3]
C0031843
UMLS CUI [1,4]
C0025344
UMLS CUI [2,1]
C0543488
UMLS CUI [2,2]
C0024501
UMLS CUI [2,3]
C0678879
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0392920
UMLS CUI [3,3]
C0205197
7. known her2/neu status.
Beschrijving

HER2/Neu Status Known

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0205309
8. negative pregnancy test within 14 days prior to starting chemotherapy.
Beschrijving

Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
9. adequate hematologic, hepatic and renal function.
Beschrijving

Hematologic function | Liver function | Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
10. signed informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
Beschrijving

Chemotherapy Malignant Neoplasms | Radiotherapy to pelvis Malignant Neoplasms | Chemotherapy Other medical condition | Radiotherapy to pelvis Other medical condition | Therapeutic procedure Affecting Ovarian function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1536155
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C3843040
UMLS CUI [4,1]
C1536155
UMLS CUI [4,2]
C3843040
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0678879
2. previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
Beschrijving

Amenorrhea Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
3. ovarian insufficiency defined as serum fsh > 20 iu/l at the local laboratory, anytime during the menstrual cycle.
Beschrijving

Ovarian Insufficiency | Serum follicle stimulating hormone measurement During Menstrual cycle

Datatype

boolean

Alias
UMLS CUI [1]
C1401084
UMLS CUI [2,1]
C0455276
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C0025329
4. any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
Beschrijving

Ovarian Disease Ultrasound pelvis | OVARIAN ABNORMALITY Ultrasound pelvis | Exception Follicular cyst Functional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029928
UMLS CUI [1,2]
C0948766
UMLS CUI [2,1]
C0149747
UMLS CUI [2,2]
C0948766
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0016427
UMLS CUI [3,3]
C0205245
5. pregnant or breastfeeding patients.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. oral, injectable, or implant hormonal contraceptives are not allowed.
Beschrijving

Contraceptive methods Unable | Contraceptive methods Unwilling | Intrauterine Devices | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Spermicidal Jelly | Total abstinence

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
UMLS CUI [3]
C0021900
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0042241
UMLS CUI [7]
C2985330
UMLS CUI [8]
C0234008
7. concurrent use of any other cytotoxic or hormonal agent, namely gnrh agonists.
Beschrijving

Cytotoxic agent | Pharmaceutical Preparations Hormonal | GnRH Agonist

Datatype

boolean

Alias
UMLS CUI [1]
C0304497
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0458083
UMLS CUI [3]
C1518041
8. prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, hiv infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
Beschrijving

Peripheral Neuropathy Pre-existing | Diabetes Mellitus | Alcohol abuse | HIV Infection | Autoimmune neuropathy | Inherited neuropathies | Amyloidosis | Hypothyroidism | Vitamin Deficiency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0019693
UMLS CUI [5]
C2748363
UMLS CUI [6]
C0598589
UMLS CUI [7]
C0002726
UMLS CUI [8]
C0020676
UMLS CUI [9]
C1510471
9. serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
Beschrijving

Heart Disease Serious Affecting Chemotherapy | Uncontrolled hypertension Affecting Chemotherapy | Medical condition Affecting Chemotherapy | Heart Disease Serious Affecting Protocol Compliance | Uncontrolled hypertension Affecting Protocol Compliance | Medical condition Affecting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0392920
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0392920
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0392760
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C1868885
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0525058
10. known sensitivity to any of the study medications.
Beschrijving

Hypersensitivity Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
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Similar models

Eligibility Breast Cancer NCT02053597

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≤ 40 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. eastern cooperative oncology group (ecog) performance status ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Invasive carcinoma of breast Primary | Eligibility Adjuvant Chemotherapy | Eligibility Chemotherapy Neoadjuvant
Item
3. non-metastatic primary invasive carcinoma of the breast eligible for adjuvant or neoadjuvant chemotherapy.
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0085533 (UMLS CUI [2,2])
C1548635 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
Estrogen receptor negative status | Progesterone Receptor Status Negative
Item
4. negative estrogen (er) and progesterone receptor (pgr) status.
boolean
C1719707 (UMLS CUI [1])
C1514471 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA
Item
5. baseline left ventricular ejection fraction (lvef) ≥50% measured by an echocardiogram or muga.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Interest Maintenance Function Menstrual | Interest Maintenance Ovarian function | Status post Chemotherapy Completion
Item
6. interested in maintaining menstrual and/or ovarian function following completion of chemotherapy.
boolean
C0543488 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0025344 (UMLS CUI [1,4])
C0543488 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
C0678879 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
HER2/Neu Status Known
Item
7. known her2/neu status.
boolean
C1512413 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Pregnancy test negative
Item
8. negative pregnancy test within 14 days prior to starting chemotherapy.
boolean
C0427780 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
9. adequate hematologic, hepatic and renal function.
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
10. signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Malignant Neoplasms | Radiotherapy to pelvis Malignant Neoplasms | Chemotherapy Other medical condition | Radiotherapy to pelvis Other medical condition | Therapeutic procedure Affecting Ovarian function
Item
1. history of prior malignant disease (breast or non-breast) or non-malignant condition which was treated with chemotherapy, pelvic irradiation or any therapy that could potentially affect ovarian function.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1536155 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C3843040 (UMLS CUI [3,2])
C1536155 (UMLS CUI [4,1])
C3843040 (UMLS CUI [4,2])
C0087111 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0678879 (UMLS CUI [5,3])
Amenorrhea Duration
Item
2. previous history of amenorrhea > 3 months within the last 2 years (excluding pregnancy).
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Ovarian Insufficiency | Serum follicle stimulating hormone measurement During Menstrual cycle
Item
3. ovarian insufficiency defined as serum fsh > 20 iu/l at the local laboratory, anytime during the menstrual cycle.
boolean
C1401084 (UMLS CUI [1])
C0455276 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0025329 (UMLS CUI [2,3])
Ovarian Disease Ultrasound pelvis | OVARIAN ABNORMALITY Ultrasound pelvis | Exception Follicular cyst Functional
Item
4. any ovarian pathology or abnormalities at the screening pelvic ultrasound, except for functional follicular cysts.
boolean
C0029928 (UMLS CUI [1,1])
C0948766 (UMLS CUI [1,2])
C0149747 (UMLS CUI [2,1])
C0948766 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0016427 (UMLS CUI [3,2])
C0205245 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
5. pregnant or breastfeeding patients.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unable | Contraceptive methods Unwilling | Intrauterine Devices | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Spermicidal Jelly | Total abstinence
Item
6. inability or unwillingness to use effective contraception during and up to 3 months after the last dose of study medication. effective methods include the following: non-hormonal intrauterine device, barrier method - condoms, diaphragm - also in conjugation with spermicidal jelly, or total abstinence. oral, injectable, or implant hormonal contraceptives are not allowed.
boolean
C0700589 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0021900 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C2985330 (UMLS CUI [7])
C0234008 (UMLS CUI [8])
Cytotoxic agent | Pharmaceutical Preparations Hormonal | GnRH Agonist
Item
7. concurrent use of any other cytotoxic or hormonal agent, namely gnrh agonists.
boolean
C0304497 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C1518041 (UMLS CUI [3])
Peripheral Neuropathy Pre-existing | Diabetes Mellitus | Alcohol abuse | HIV Infection | Autoimmune neuropathy | Inherited neuropathies | Amyloidosis | Hypothyroidism | Vitamin Deficiency
Item
8. prior pre-existing peripheral neuropathy of any cause, including diabetes mellitus, alcohol abuse, hiv infection, autoimmune and hereditary neuropathies, amyloidosis, hypothyroidism, vitamin deficiencies.
boolean
C0031117 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C2748363 (UMLS CUI [5])
C0598589 (UMLS CUI [6])
C0002726 (UMLS CUI [7])
C0020676 (UMLS CUI [8])
C1510471 (UMLS CUI [9])
Heart Disease Serious Affecting Chemotherapy | Uncontrolled hypertension Affecting Chemotherapy | Medical condition Affecting Chemotherapy | Heart Disease Serious Affecting Protocol Compliance | Uncontrolled hypertension Affecting Protocol Compliance | Medical condition Affecting Protocol Compliance
Item
9. serious cardiac illness, uncontrolled hypertension or medical condition that would affect administration of chemotherapy and compliance to study procedures.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,4])
C1868885 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C0018799 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C1868885 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Hypersensitivity Investigational New Drugs
Item
10. known sensitivity to any of the study medications.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
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