ID

6165

Beschreibung

FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF84340-BD14-67AC-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABF84340-BD14-67AC-E034-0003BA12F5E7

Stichworte

Klinische Studie [Dokumenttyp]

Behandlungsbedürftigkeit, Begutachtung

Mammatumoren, Mensch

26.08.12 26.08.12 -
12.12.14 12.12.14 - Martin Dugas
13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus

Hochgeladen am

12. Dezember 2014

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00090974 On-Study - FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27 - 2067101v3.0

Modell
Details

A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

1 Formulare

StudyEvent: FORM 1 - ELIGIBILITY CHECK LIST AND INITIAL EVALUATION MA.27
1. A RANDOMIZED PHASE III TRIAL OF EXEMESTANE VERSUS ANASTROZOLE WITH OR WITHOUT CELECOXIB IN POSTMENOPAUSAL WOMEN WITH RECEPTOR POSITIVE PRIMARY BREAST CANCER-MA.27

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

PATIENT INFORMATION

Item Group

Patient Information

PatientMedicalRecordNumber

Item

Patient Medical Record Number

text

InvestigatorName

Item

Investigator Name

text

InstitutionName

Item

Institution Name

text

RegisteredInvestigator

Item

Registered Investigator (NCI Investigator #)

text

Patient birth date

Item

Patient's Date of Birth (yyyy mmm dd)

date

C16960 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C0421451 (UMLS CUI-1)

PatientGender

Item

Patient Gender

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17357 (NCI Thesaurus Property)
C0079399 (UMLS 2011AA Property)

CL.1

Code List

Patient Gender

CL Item

Male (Male)

CL Item

Female (Female)

PatientRace

Item

Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.2

Code List

Patient Race (check all that apply Patient is encouraged to self designate: Race Categories and Definitions definitions given with each value)

CL Item

White_cdus (White)

CL Item

Black_cdus (Black or African American)

CL Item

Pacific_islander_cdus (Native Hawaiian or other Pacific Islander)

CL Item

Asian_cdus (Asian)

CL Item

Native_american_cdus (American Indian or Alaska Native)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientEthnicity

Item

Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17049 (NCI Thesaurus Property)
C0034510 (UMLS 2011AA Property)

CL.3

Code List

Patient Ethnicity (check one only Ethnicity Categories and Definitions definition given with value value)

CL Item

Hispanic_or_latino (Hispanic or Latino)

CL Item

Non_hispanic (Non-Hispanic)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PaymentMethod

Item

Payment method (check one USA only)

text

CL.4

Code List

Payment method (check one USA only)

CL Item

Private Insurance (Private Insurance)

CL Item

Medicare (Medicare)

C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)

CL Item

Medicare And Private Insurance (Medicare and Private Insurance)

CL Item

Medicaid (Medicaid)

C0025071 (NCI Metathesaurus)

CL Item

Medicaid And Medicare (Medicaid and Medicare)

CL Item

Military Or Veterans Sponsored Nos (Military or Veterans Sponsored NOS)

CL Item

Military Sponsored (including Champus & Tricare) (Military sponsored (including CHAMPUS and TRICARE))

CL Item

Veterans Sponsored (Veterans Sponsored)

CL Item

Self Pay (no Insurance) (Self pay (no insurance))

CL Item

No Means Of Payment (no Insurance) (No means of payment (no insurance))

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

IRBApprovalDate

Item

IRB/REB Approval Date ([initial approval or annual renewal] yyyy mmm dd)

date

C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25425 (NCI Thesaurus Property)
C0205540 (UMLS 2011AA Property)

ProjectedTreatmentBeginDate

Item

Projected Start Date of Treatment ([within 10 working days of randomization] yyyy mmm dd)

date

ELIGIBILITY CHECKLIST

Item Group

Eligibility Checklist

Completely resected and histologically confirmed invasive breast carcinoma

Item

Patient has completely resected and histologically confirmed invasive breast carcinoma.

boolean

PriorAdjuvantChemotherapyEndDate

Item

Date Prior Adjuvant Chemotherapy Ended (yyyy-mmm-dd)

date

TNMClassificationScheme

Item

Pathological TNM classification is (M stage)

text

CL.7

Code List

Pathological TNM classification is (M stage)

CL Item

M0 (M0)

TNMClassificationScheme

Item

Pathological TNM classification is (M stage)

text

CL.7

Code List

Pathological TNM classification is (M stage)

CL Item

M0 (M0)

TNMClassificationScheme

Item

Pathological TNM classification is (M stage)

text

CL.7

Code List

Pathological TNM classification is (M stage)

CL Item

M0 (M0)

Primary tumour receptorpositive

Item

Primary tumour is receptor positive i.e. ER and/or PgR positive (defined as receptor content of >= 10fmol/mg protein or receptor positive by ERICA or PgRICA).

boolean

If bilateral breast cancer then diagnosed simultaneously and receptor positive

Item

If patient has bilateral breast cancer, both were diagnosed at the same time and at least one of the bilateral cancers is receptor positive (as defined above)

boolean

VerificationofPostmenopausalStatus

Item

Patient is post-menopausal according to one of these three criteria

text

C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)

CL.20

Code List

Patient is post-menopausal according to one of these three criteria

CL Item

greater than (>) 55 years of age with no spontaneous menses for at least 12 months; (greater than (>) 55 years of age with no spontaneous menses for at least 12 months;)

CL Item

less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards (less or equal to (<=) 55 years of age with no spontaneous menses within the past 12 months (i.e. spontaneous cessation or secondary to hysterectomy) AND with and FSH level in the postmenopausal range according to institutional/laboratory standards)

CL Item

Bilateral Oophorectomy (bilateral oophorectomy)

FSHvalue

Item

FSH value

text

FSH date

Item

Date (FSH value) (yyyy mmm dd)

date

C25164 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C2286 (NCI Thesaurus Property)
C0011008 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0733758 (UMLS CUI-4)

No Metastases in radiologic investigations within 4 weeks prior to surgical resection

Item

Radiologic investigations have been completed within 4 weeks prior to surgical resection of primary tumour and are negative for metastases

boolean

Radiologic investigations completed

Item

Radiologic investigations have been completed (To specify investigations)

integer

CL.10

Code List

Radiologic investigations have been completed (To specify investigations)

CL Item

Bone Scan (1)

CL Item

Abdominal Ultrasound Or Ct Abdomen (2)

CL Item

Chest X-ray (3)

bonescan

Item

bone scan (required only if alkaline phosphatase is >= 2 x UNL and/or there are symptoms of metastatic disease a confirmatory x-ray or other imaging study such as CT or MRI is required if the results from the bone scan are questionable)

text

CL.11

Code List

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

abdominalultrasoundorCTabdomen

Item

abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)

text

CL.12

Code List

abdominal ultrasound or CT abdomen (required only if the AST/ALT or alkaline phosphatase is > 2 x UNL unless the elevation is in the bone fraction)

CL Item

Not Applicable (Not Applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

ChestX-RayAssessmentDate

Item

Date of chest x-ray (yyyy mmm dd)

date

Bilateral Mammogram within 10 months

Item

Patient has had a bilateral mammogram within 10 months prior to randomization.

boolean

C20178 (NCI Thesaurus ObjectClass)
C13332 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
CL158135 (NCI Metathesaurus Property)
C0024671 (UMLS CUI-1)
C0238767 (UMLS CUI-2)
C0013893 (UMLS CUI-3)

Dateofbilateralmammogram

Item

Date of bilateral mammogram (yyyy mmm dd)

text

If adjuvant chemotherapy then within 3 weeks to 3 months

Item

If patient has received prior adjuvant chemotherapy, no less than 3 weeks and no more than 3 months have elapsed since completion of chemotherapy (planned radiotherapy may be given concurrently with protocol therapy).

boolean

Minimum life expectancy of 5 years

Item

Patient has a minimum life expectancy of 5 years.

boolean

PerformanceStatus

Item

Performance Status (ECOG) is (circle one see Appendix II)

text

CL.14

Code List

Performance Status (ECOG) is (circle one see Appendix II)

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1 (1)

CL Item

2 (2)

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

Patientis able to swallow study medication and adequate unassisted oral intake

Item

Patient is able to swallow the study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.

boolean

Compliance with study visits

Item

Patient is able and willing to comply with scheduled study visits at the participating centre.

boolean

Informed consent

Item

Informed consent has been signed and dated by patient.

boolean

C0021430 (UMLS CUI-1)

InformedConsentDateSigned

Item

Date informed consent signed (yyyy mmm dd)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Stratification

Item Group

Stratification

AxillaryNodes

Item

Axillary Nodes

text

CL.15

Code List

Axillary Nodes

CL Item

Regional Lymph Nodes Cannot Be Assessed (e.g., Previously Removed) (NX)

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)

PriorAdjuvantChemotherapyInd

Item

Prior adjuvant chemotherapy?

text

CL.41

Code List

Prior adjuvant chemotherapy?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Chroniclowdoseprophylacticaspirinuse

Item

Chronic low dose prophylactic aspirin use

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.17

Code List

Chronic low dose prophylactic aspirin use

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

ELIGIBILITY CHECKLIST continued

Item Group

Eligibility Checklist Continued

Hematologic investigations matching eligibility criteria within 4 weeks prior to randomization

Item

Required hematologic investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility.

boolean

Biochemistry investigations within 4 weeks match eligibility criteria

Item

Required biochemistry investigations done within 4 weeks prior to randomization and are within the required parameters for eligibility unless imaging examinations have ruled out metastatic disease.

boolean

TreatmentRequirementBeginIndicator

Item

Initiation of protocol therapy will begin within 10 working days of randomization.

text

No history of other non-curated malignancies within past 5 years

Item

Patient has no history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumours curatively treated with no evidence of disease for >= 5 years from randomization.

boolean

No concurrent hormonal therapy

Item

Patient is not receiving concurrent hormonal therapy with estrogens, progesterones, androgens or any selective estrogen receptor modulator (SERM). (previous use of Raloxifene, specifically, is permitted provided this is discontinued at least 3 weeks prior to randomization; intermittent use, i.e. maximum of 2 x per week, of vaginal estrogens is permitted on protocol if other local [trunc. see form])

boolean

No prior treatment with aromataseinhibitor

Item

No prior treatment with a recognized aromatase inhibitor.

boolean

No peptic ulcer disease

Item

No known or incompletely treated peptic ulcer disease.

boolean

No concurrent NSAID or Cox-2 Inhibitor therapy

Item

Patient is not receiving concurrent NSAID therapy or Cox-2 Inhibitor therapy e.g. Vioxx. (chronic low dose, i.e. <= 81 mg/day, prophylactic aspirin will be allowed)

boolean

Noknownallergytosulphonamides.

Item

No known allergy to sulphonamides.

text

No allergic reaction to NSAIDs

Item

No history of asthma, urticaria or allergic type reactions after taking aspirin or other NSAIDs.

boolean

No co-existing interfering medical or psychiatric conditions

Item

No co-existing medical or psychiatric condition that is likely to interfere with study procedures or results.

boolean

Permission from sponsor of other trial

Item

If patient has participated in another trial for breast cancer (e.g. adjuvant chemotherapeutic trial), permission has been obtained, from the sponsors of that trial for the patients to participate in MA.27.

boolean

RandomizationDate

Item

Randomization Date (yyyy mmm dd)

date

Certificate of Eligibility

Item Group

Certificate Of Eligibility

PatientEligibilityInd

Item

In the opinion of the investigator is the patient eligible?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25171 (NCI Thesaurus Property)
C0013893 (UMLS 2011AA Property)

CL.18

Code List

In the opinion of the investigator is the patient eligible?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

InvestigatorSignature

Item

Investigator Signature

text

C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Date of Investigator Signature (yyyy mmm dd)

date

PersonCompletingForm,LastName

Item

Person Completing Form, Last Name

text

PersonCompletingForm,FirstName

Item

Person Completing Form, First Name

text

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompletionDate,Original

Item

Form Completion Date, Original (yyyy mmm dd)

date

HISTORY AND PHYSICAL EXAM

Item Group

History And Physical Exam

AssessmentDate

Item

Date of Evaluation (yyyy-mmm-dd)

date

PerformanceStatus

Item

Performance Status (check one see protocol Appendix II)

text

CL.19

Code List

Performance Status (check one see protocol Appendix II)

CL Item

0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100))

C0919414 (NCI Metathesaurus)

CL Item

1 (Restricted in physically strenuous activity but ambulatory (K 70 - 80))

CL Item

2 (Ambulatory and capable of all self-care but unable to carry out any work activities (K 50 - 60))

C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)

CL Item

3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours (K 30-40))

CL Item

4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair (K 10-20))

PatientHeight

Item

Patient Height (cm)

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25347 (NCI Thesaurus Property)
C0489786 (UMLS 2011AA Property)

PatientWeight

Item

Patient Weight (kg)

double

VerificationofPostmenopausalStatus

Item

Patient is post-menopausal according to one of these three criteria

text

C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)

CL.20

Code List

Patient is post-menopausal according to one of these three criteria

CL Item

greater than (>) 55 years of age with no spontaneous menses for at least 12 months; (greater than (>) 55 years of age with no spontaneous menses for at least 12 months;)

CL Item

Bilateral Oophorectomy (bilateral oophorectomy)

FSHvalue

Item

FSH value

text

FSH date

Item

Date (FSH value) (yyyy mmm dd)

date

INVESTIGATIONS

Item Group

Investigations

DiagnosticImagingAnatomicSite

Item

Imaging Site

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C25421 (NCI Thesaurus Property)
C0002808 (UMLS 2011AA Property)

CL.21

Code List

Imaging Site

CL Item

Chest (Chest)

C25389 (NCI Thesaurus)
C0817096 (UMLS 2011AA)

CL Item

Abdomen (Abdomen)

C12664 (NCI Thesaurus)
C0230168 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

AssessmentDate

Item

Date of Evaluation (yyyy-mmm-dd)

date

AssessmentType

Item

Method of Evaluation

text

CL.22

Code List

Method of Evaluation

CL Item

Chest X-ray (Chest X-ray)

CL Item

Ct Scan (CT Scan)

CL Item

Mri (MRI (NMR))

CL Item

Bilateral Mammogram (Bilateral Mammogram)

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Bone Scan (Bone Scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Not Evaluated (Not Evaluated)

INVESTIGATIONS continued BASELINE HEMATOLOGY/BIOCHEMISTRY VALUES

Item Group

Investigations Continued Baseline Hematology/biochemistry Values

Hematology lab date

Item

Date Hematology (Blood) Sample Obtained (yyyy mmm dd)

date

Hemoglobin

Item

Hemoglobin (Value)

float

C0019046 (UMLS CUI-1)

Lab,Hematology,Platelets

Item

Peripheral Platelet Count (Value)

double

Lab,Hematology,WBC

Item

Peripheral WBC Count (Value)

double

Lab,UnitsofMeasure

Item