ID

35855

Beskrivning

Preoperative Olaparib Endometrial Carcinoma Study (POLEN); ODM derived from: https://clinicaltrials.gov/show/NCT02506816

Länk

https://clinicaltrials.gov/show/NCT02506816

Nyckelord

Versioner (1)
  1. 3/28/19 3/28/19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

March 28, 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Endometrial Carcinoma NCT02506816

Engelsk

Eligibility Endometrial Carcinoma NCT02506816

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically-confirmed type i primary endometrial carcinoma (ec). diagnosis biopsy must contain 3-12 mg of tumour cellularity/stroma (tumour: 5-20 mm) and this will be checked in the central laboratory for this trial. if tumour cellularity/stroma is inadequate, one re-biopsy with adequate tumour cellularity/stroma will be mandatory before study entry.
Beskrivning

Endometrial Carcinoma Primary Type | Biopsy Tumor Cellularity | Biopsy Tumor Stroma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0476089
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C0332307
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0178539
UMLS CUI [3,1]
C0005558
UMLS CUI [3,2]
C0027651
UMLS CUI [3,3]
C0927195
who performance status ≤ 2.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
adequate bone marrow function as shown by: anc ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb >10g/dl.
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
adequate liver function as shown by:
Beskrivning

Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
serum bilirubin ≤ 1.5 x uln inr < 1.3 (or < 3 on anticoagulants) alt and ast ≤ 2.5x uln
Beskrivning

Serum total bilirubin measurement | International Normalized Ratio | Relationship Anticoagulants | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0525032
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0003280
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
adequate renal function: serum creatinine ≤ 1.5 x mg/dl.
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
fasting serum cholesterol ≤300 mg/dl or ≤7.75 mmol/l and fasting triglycerides ≤ 2.5 x uln.
Beskrivning

Serum cholesterol measurement Fasting | Serum fasting triglyceride measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0587184
UMLS CUI [1,2]
C0015663
UMLS CUI [2]
C0582824
signed informed consent, including consent to tissue collection and blood samples as specified by the protocol.
Beskrivning

Informed Consent | Consent Tissue collection | Consent Blood specimen

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C0040278
UMLS CUI [3,1]
C1511481
UMLS CUI [3,2]
C0178913
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have received prior anticancer therapies for the current endometrial cancer (including chemotherapy, radiotherapy, antibody based therapy, hormonotherapy or surgery).
Beskrivning

Cancer treatment Previous Endometrial Carcinoma | Chemotherapy | Therapeutic radiology procedure | Antibody therapy | Hormone Therapy | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0476089
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0281176
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0543467
patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
Beskrivning

Major surgery | Traumatic injury | Side effects Major surgery Recovery Lacking | Side effects Requirement General Anesthesia | Patient need for Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0679637
UMLS CUI [3,3]
C2004454
UMLS CUI [3,4]
C0332268
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0002915
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C0679637
prior treatment with any investigational drug within the preceding 4 weeks.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. however, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior the study entry. topical or inhaled corticosteroids are allowed.
Beskrivning

Systemic therapy chronic | Adrenal Cortex Hormones | Immunosuppressive Agents | Exception Adrenal Cortex Hormones Dose U/day | Exception Adrenal Cortex Hormones Equivalent Prednisone | Adrenal Cortex Hormones Dose Stable | Topical corticosteroids allowed | Adrenal Cortex Hormones Inhaled allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0021081
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0001617
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0456683
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0001617
UMLS CUI [5,3]
C0205163
UMLS CUI [5,4]
C0032952
UMLS CUI [6,1]
C0001617
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7,1]
C0304604
UMLS CUI [7,2]
C0683607
UMLS CUI [8,1]
C0001617
UMLS CUI [8,2]
C0001559
UMLS CUI [8,3]
C0683607
patients who have received immunization with attenuated live vaccines within one week of study entry (note: during study period these kind of vaccines are also not allowed).
Beskrivning

Immunization | Attenuated Live Virus Vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0020971
UMLS CUI [2]
C1516086
patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Beskrivning

Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C2348568
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C2348568
symptomatic congestive heart failure of new york heart association class iii or iv unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln active (acute or chronic) or uncontrolled severe infections liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis a known history of hiv seropositivity.
Beskrivning

Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Serious Uncontrolled | Heart Diseases | Pulmonary function impairment Severe | Diabetic - poor control | Serum fasting glucose level Elevated | Serum fasting glucose level Elevated chronic | Communicable Diseases Severe Uncontrolled | Liver diseases | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027051
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0205318
UMLS CUI [5]
C0018799
UMLS CUI [6,1]
C0858943
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0421258
UMLS CUI [8,1]
C1318372
UMLS CUI [8,2]
C3163633
UMLS CUI [9,1]
C1318372
UMLS CUI [9,2]
C3163633
UMLS CUI [9,3]
C0205191
UMLS CUI [10,1]
C0009450
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C0205318
UMLS CUI [11]
C0023895
UMLS CUI [12]
C0023890
UMLS CUI [13]
C0019189
UMLS CUI [14]
C0149519
UMLS CUI [15]
C0019699
patients with an active, bleeding diathesis.
Beskrivning

Bleeding tendency

Datatyp

boolean

Alias
UMLS CUI [1]
C1458140
female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. if barrier contraceptives are being used, these must be continued throughout the trial by both sexes. hormonal contraceptives are acceptable as a sole method of contraception. (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of azd2281).
Beskrivning

Pregnancy | Breast Feeding | Adult Females & males of reproductive potential Contraceptive methods Absent | Contraception, Barrier | Hormonal contraception | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0001675
UMLS CUI [3,2]
C4034483
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0332197
UMLS CUI [4]
C0004764
UMLS CUI [5]
C2985296
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430061
history of noncompliance to medical regimens.
Beskrivning

Lacking Compliance behavior Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0087111
patients unwilling to or unable to comply with the protocol.
Beskrivning

Protocol Compliance Unwilling | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Endometrial Carcinoma NCT02506816

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Endometrial Carcinoma Primary Type | Biopsy Tumor Cellularity | Biopsy Tumor Stroma
Item
patients must have histologically-confirmed type i primary endometrial carcinoma (ec). diagnosis biopsy must contain 3-12 mg of tumour cellularity/stroma (tumour: 5-20 mm) and this will be checked in the central laboratory for this trial. if tumour cellularity/stroma is inadequate, one re-biopsy with adequate tumour cellularity/stroma will be mandatory before study entry.
boolean
C0476089 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0178539 (UMLS CUI [2,3])
C0005558 (UMLS CUI [3,1])
C0027651 (UMLS CUI [3,2])
C0927195 (UMLS CUI [3,3])
WHO performance status scale
Item
who performance status ≤ 2.
boolean
C1298650 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
adequate bone marrow function as shown by: anc ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, hb >10g/dl.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Liver function
Item
adequate liver function as shown by:
boolean
C0232741 (UMLS CUI [1])
Serum total bilirubin measurement | International Normalized Ratio | Relationship Anticoagulants | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum bilirubin ≤ 1.5 x uln inr < 1.3 (or < 3 on anticoagulants) alt and ast ≤ 2.5x uln
boolean
C1278039 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0003280 (UMLS CUI [3,2])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
Renal function | Creatinine measurement, serum
Item
adequate renal function: serum creatinine ≤ 1.5 x mg/dl.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum cholesterol measurement Fasting | Serum fasting triglyceride measurement
Item
fasting serum cholesterol ≤300 mg/dl or ≤7.75 mmol/l and fasting triglycerides ≤ 2.5 x uln.
boolean
C0587184 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0582824 (UMLS CUI [2])
Informed Consent | Consent Tissue collection | Consent Blood specimen
Item
signed informed consent, including consent to tissue collection and blood samples as specified by the protocol.
boolean
C0021430 (UMLS CUI [1])
C1511481 (UMLS CUI [2,1])
C0040278 (UMLS CUI [2,2])
C1511481 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Previous Endometrial Carcinoma | Chemotherapy | Therapeutic radiology procedure | Antibody therapy | Hormone Therapy | Operative Surgical Procedures
Item
subjects who have received prior anticancer therapies for the current endometrial cancer (including chemotherapy, radiotherapy, antibody based therapy, hormonotherapy or surgery).
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0476089 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0281176 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0543467 (UMLS CUI [6])
Major surgery | Traumatic injury | Side effects Major surgery Recovery Lacking | Side effects Requirement General Anesthesia | Patient need for Major surgery
Item
patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0879626 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
C2004454 (UMLS CUI [3,3])
C0332268 (UMLS CUI [3,4])
C0879626 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0002915 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C0679637 (UMLS CUI [5,2])
Investigational New Drugs
Item
prior treatment with any investigational drug within the preceding 4 weeks.
boolean
C0013230 (UMLS CUI [1])
Systemic therapy chronic | Adrenal Cortex Hormones | Immunosuppressive Agents | Exception Adrenal Cortex Hormones Dose U/day | Exception Adrenal Cortex Hormones Equivalent Prednisone | Adrenal Cortex Hormones Dose Stable | Topical corticosteroids allowed | Adrenal Cortex Hormones Inhaled allowed
Item
patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. however, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior the study entry. topical or inhaled corticosteroids are allowed.
boolean
C1515119 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0456683 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0001617 (UMLS CUI [5,2])
C0205163 (UMLS CUI [5,3])
C0032952 (UMLS CUI [5,4])
C0001617 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0304604 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C0001617 (UMLS CUI [8,1])
C0001559 (UMLS CUI [8,2])
C0683607 (UMLS CUI [8,3])
Immunization | Attenuated Live Virus Vaccine
Item
patients who have received immunization with attenuated live vaccines within one week of study entry (note: during study period these kind of vaccines are also not allowed).
boolean
C0020971 (UMLS CUI [1])
C1516086 (UMLS CUI [2])
Medical condition Severe Affecting Study Subject Participation Status | Medical condition Uncontrolled Affecting Study Subject Participation Status | Condition Affecting Study Subject Participation Status
Item
patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Symptomatic congestive heart failure New York Heart Association Classification | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Serious Uncontrolled | Heart Diseases | Pulmonary function impairment Severe | Diabetic - poor control | Serum fasting glucose level Elevated | Serum fasting glucose level Elevated chronic | Communicable Diseases Severe Uncontrolled | Liver diseases | Liver Cirrhosis | Hepatitis, Chronic | Chronic Persistent Hepatitis | HIV Seropositivity
Item
symptomatic congestive heart failure of new york heart association class iii or iv unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease severely impaired lung function uncontrolled diabetes as defined by fasting serum glucose >1.5 x uln active (acute or chronic) or uncontrolled severe infections liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis a known history of hiv seropositivity.
boolean
C0742758 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0018799 (UMLS CUI [5])
C0858943 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0421258 (UMLS CUI [7])
C1318372 (UMLS CUI [8,1])
C3163633 (UMLS CUI [8,2])
C1318372 (UMLS CUI [9,1])
C3163633 (UMLS CUI [9,2])
C0205191 (UMLS CUI [9,3])
C0009450 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0205318 (UMLS CUI [10,3])
C0023895 (UMLS CUI [11])
C0023890 (UMLS CUI [12])
C0019189 (UMLS CUI [13])
C0149519 (UMLS CUI [14])
C0019699 (UMLS CUI [15])
Bleeding tendency
Item
patients with an active, bleeding diathesis.
boolean
C1458140 (UMLS CUI [1])
Pregnancy | Breast Feeding | Adult Females & males of reproductive potential Contraceptive methods Absent | Contraception, Barrier | Hormonal contraception | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. if barrier contraceptives are being used, these must be continued throughout the trial by both sexes. hormonal contraceptives are acceptable as a sole method of contraception. (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of azd2281).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C4034483 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0004764 (UMLS CUI [4])
C2985296 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430061 (UMLS CUI [7,2])
Lacking Compliance behavior Therapy
Item
history of noncompliance to medical regimens.
boolean
C0332268 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients unwilling to or unable to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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