Protocol for an integrated data request of test results from the laboratories of pathological anatomy

Transcription

1 Protocol for an integrated data request of test results from the laboratories of pathological anatomy Cancer diagnoses & early detection of cancer (breast, colorectal and cervix) CODAP page 1

2 Table of contents Introduction... 3 Contact information Data transfer: general principles Which data should be transferred? Data format Missing information Submission of protocols ( written reports ) Means of delivery Data transfer: detailed overview Cancer diagnoses A. Inclusion criteria B. Dataset for cancer diagnoses C. Detailed information about the variables Test results of breast and colorectal specimens A. Inclusion criteria B. Dataset for breast and colorectal specimens C. Detailed information about the variables Test results of cervical smears and biopsies-including HPV tests A. Inclusion criteria B. Dataset for cervical smears and biopsies-including HPV tests C. Detailed information about the variables CODAP page 2

3 Introduction This document will provide a set of instructions on how to transfer data on cancer diagnosis and test results of early cancer detection to the Belgian Cancer Registry. The aim is to provide a clear description of a standardized and integrated protocol describing how data should be transferred, allowing us to process this information and enabling the use of your data e.g. for national and international descriptive statistics on cancer incidence. Please transfer this document to your IT service and/or to the people responsible for assembling the dataset(s). The legal basis for the work of the Belgian Cancer Registry can be found in: The law of 13 December 2006 called: Wet houdende diverse bepalingen betreffende gezondheid (1), hoofdstuk VI, Artikel 39 Loi portant dispositions diverses en matière de santé (1), chapitre VI, Article 39 Recent changes in this law relevant to this data request were published in the Belgisch Staatsblad / Moniteur Belge on the 2nd of June 2010 (art. 29). Contact information For additional information or support, please contact the Belgian Cancer Registry at: 02/ info@kankerregister.org info@registreducancer.org CODAP page 3

4 1. Data transfer: general principles 1.1 Which data should be transferred? The Belgian Cancer Registry kindly asks you to transfer all data concerning these four topics: 1. One file containing all encoded cancer diagnoses and a separate file with the written reports (i.e. protocols ); 2. One file containing the encoded test results of all breast specimens and a separate file with the written reports (i.e. protocols ); 3. One file containing the encoded test results of all colorectal specimens and a separate file with the written reports (i.e. protocols ); 4. One file containing the encoded test results of all cervical smears and biopsies and a separate file with the written reports (i.e. protocols ). A detailed description of each data set is stated below. Remark: When following these procedures, it is normal that if a cancer is diagnosed in an early detection program, it will result in double registration: once in the cancer diagnosis file and once in the breast specimens, colorectal specimens or cervical smears and biopsies file. 1.2 Data format The file format is a tab separated text. 1.3 Missing information If certain information is not present in your database you can fill out the column with: #NS #NK #NA not stated or not present unknown not applicable CODAP page 4

5 1.4 Submission of protocols ( written reports ) The anonymous protocols should preferably be submitted in one file as a tab separated text format with a clear delimiter between the different protocols. The specimen number should be mentioned in the protocol. 1.5 Means of delivery Data are delivered preferably on CD-ROM secured by a password and sent to the Belgian Cancer Registry by a recorded delivery (aangetekende verzending / envoi recommandé) attended to the medical supervisor Dr. Liesbet Van Eycken at the following address. Stichting Kankerregister/Fondation Registre du Cancer For the attention of Dr. Liesbet Van Eycken, Medical Supervisor Koningsstraat Brussel Alternatively, the data can be sent by by means of a password secured zip file to the medical supervisor (elizabeth.vaneycken@kankerregister.org). In both cases, the password must be communicated to the Cancer Registry by telephone. CODAP page 5

6 2. Data transfer: detailed overview 2.1 Cancer diagnoses 2.1.A. Inclusion criteria Range to select: CODAP: all lesion codes equal or greater than 60+ codes, CIN3, GIN3, VIN3 and PIN3. (equivalent for ICD-O-3: 8000/0-9999/9.) All malignant tumours, invasive or in situ. All hematological tumours including the myelodysplastic syndromes and myeloproliferative diseases. All tumours of the central nervous system whatever the behavior of the tumour (benign, low malignant potential, malignant). All urothelial cell tumours (low malignant potential, in situ, invasive). Ovary: malignant and borderline malignant epithelial tumours. CODAP page 6

7 2.1.B. Dataset for cancer diagnoses Variable Compulsory Format Comment or optional 1 National number C 11 characters, Leading zero's should be conserved! (INSZ / NISS) text format without space 2 Last name O free text field Compulsory if INSZ/NISS unknown 3 First Name O free text field Compulsory if INSZ/NISS unknown 4 Sex C MALE or FEMALE 5 Date of birth C yyyymmdd 6 Date of death O yyyymmdd Only if applicable 7 Zip code C free text field 8 Country code C 2 characters, text format Code of the legal residence of the person: names_and_code_elements 9 Specimen number C free text field Should match the specimen number in the protocol. 10 Date specimen was taken C yyyymmdd 11 Requesting hospital O free text field 12 Organ C free text field All organ codes Name of the hospital that requests the pathological examination 13 Lesion C free text field Range to select: all lesion codes >= 60 and CIN3, GIN3, VIN3, PIN3. 14 pt O free text field Please use TNM 7th edition for all diagnoses from 2010 onwards 15 pn O free text field Please use TNM 7th edition for all diagnoses from 2010 onwards 16 pm O free text field Please use TNM 7th edition for all diagnoses from 2010 onwards 17 Degree of certainty O 1=uncertain 2=differential diagnosis 3=certain In grey the administrative block which is similar for all types of registration C = compulsory - O= optional : to be added CODAP page 7

8 2.1.C. Detailed information about the variables Date specimen was taken (Variable 10) Take care to fill in the date the specimen was taken and not the date of analysis. Requesting hospital (Variable 11) Fill in the hospital (campus/laboratory) that sent the specimen, requested the pathological examination and to which the result is reported. Lesion (Variable 13) If possible please encode lateralization (left or right). CODAP page 8

9 2.2 Test results of breast and colorectal specimens 2.2.A. Inclusion criteria The datasets for the breast and colorectal specimens are identical; however the test results should be delivered in separate files. Range to select: 1. For the file containing the encoded test results of all breast specimens: CODAP: organ codes 69XX (equivalent for ICD-O-3: C50.X) All encoded test results of breast specimens, including negative, benign and premalignant lesions. 2. For the file containing the encoded test results of all colorectal specimens: CODAP: organ codes 41XX, 42XX, 43XX (equivalent for ICD-O-3: C18.X, C19.X, C20.X, C21.X) All encoded test results of colorectal specimens, including negative, benign and premalignant lesions. CODAP page 9

10 2.2.B. Dataset for breast and colorectal specimens Variable Compulsory Format Comment or optional 1 National number C 11 characters, Leading zero's should be conserved! (INSZ / NISS) text format without space 2 Last name O free text field Compulsory if INSZ/NISS unknown 3 First Name O free text field Compulsory if INSZ/NISS unknown 4 Sex C MALE or FEMALE 5 Date of birth C yyyymmdd 6 Date of death O yyyymmdd Only if applicable 7 Zip code C free text field 8 Country code C 2 characters, text format Code of the legal residence of the person: names_and_code_elements 9 Specimen number C free text field Should match the specimen number in the protocol 10 Date specimen was taken C yyyymmdd 11 Requesting hospital O free text field 12 RIZIV/INAMI number of the demander of the test 13 Organ C free text field 14 Lesion 15 Degree of certainty O 1=uncertain 2=differential diagnosis 3=certain 16 Nomenclature number(s) C text format without space C = compulsory - O= optional : to be added C C 11 numbers text format without space free text field In grey the administrative block which is similar for all types of registration Name of the hospital that requests the pathological examination Range to select: File colorectal: 41XX,42XX 43XX File breast: 69XX All test results including negative tests Different numbers to be entered separated by commas "," CODAP page 10

11 2.2.C. Detailed information about the variables Date specimen was taken (Variable 10) Take care to fill in the date the specimen was taken and not the date of analysis. Requesting hospital (Variable 11) Please fill in the hospital (campus/laboratory) that sent the specimen, requested the pathological examination and to which the result is reported. RIZIV/INAMI number of the demander (Variable 12) Data bases for registration of screening results will be set up. One of the goals is to integrate all information from different sources to set up complete individual patient histories. Another tool that will be included in screening data bases is the fail-safe mechanism. This is a back-up mechanism which ensures that patients with an abnormal screening result will have the appropriate follow up. If this fails, we can identify what went wrong, by using the variable requesting hospital (variable 11) and the RIZIV/INAMI number of the demander (variable 12). Lesion (Variable 14) Please fill in the diagnostic codes. If possible encode lateralization (left or right). Provide a table with codes used for negative, benign and premalignant lesions if you have one. Nomenclature number(s) (Variable 16) Please fill in the nomenclature number(s) associated with the corresponding specimens if known. In case of more than one nomenclature number, they should be entered separated by a comma (, ). CODAP page 11

12 2.3 Test results of cervical smears and biopsies 2.3.A. Inclusion criteria Range to select: CODAP: organ codes 64XX, 65XX. (equivalent for ICD-O-3: C52.X, C53.X ) All cervical and vaginal cytology test results including negative tests (no abnormalities) and light or moderate cell abnormalities. All cervical histology test results including negative tests (no abnormalities) and light or moderate cell abnormalities. Results of high risk HPV tests. CODAP page 12

13 2.3.B. Dataset for test results of cervical smears and biopsies- including HPV tests Variable Compulsory Format Comment or optional 1 National number C 11 characters, Leading zero's should be conserved! (INSZ / NISS) text format without space 2 Last name O free text field Compulsory if INSZ/NISS unknown 3 First Name O free text field Compulsory if INSZ/NISS unknown 4 Sex C MALE or FEMALE 5 Date of birth C yyyymmdd 6 Date of death O yyyymmdd Only if applicable 7 Zip code C free text field 8 Country code C 2 characters, text format Code of the legal residence of the person: mes_and_code_elements 9 Specimen number C free text field Should match the specimen number in the protocol. 10 Date specimen was taken C yyyymmdd 11 Requesting hospital O free text field Name of the hospital that requests the pathological examination 12 RIZIV/INAMI number of the demander of the test 13 Quality of the specimen C C 11 numbers text format without space SUF+, SUF-, INSU Only for pap smears 14 Organ C free text field Range to select: 64XX, 65XX 15 Lesion C free text field All test results including negative tests, benign and premalignant lesions 16 Degree of certainty 17 HPV high risk test results 18 HPV high risk types detected 19 Nomenclature number(s) C C = compulsory - O= optional : to be added O C if HPV test performed 1=uncertain 2=differential diagnosis 3=certain HPV-, HPV+, HPVi HP16,HP18,,,, free text field text field without space In grey the administrative block which is similar for all types of registration O Applies to lesion Several answers possible Different HPV types to be entered separated by commas "," Several answers possible Different numbers to be entered separated by commas "," CODAP page 13

14 2.3.C. Detailed information about the variables Date specimen was taken (Variable 10) Take care to fill in the date the specimen was taken and not the date of analysis. Requesting hospital (Variable 11) Please fill in the hospital (campus/laboratory) that sent the specimen, requested the pathological examination and to which the result is reported. RIZIV/INAMI number of the demander (Variable 12) See also section 2.2.C. (detailed information about the variables of the dataset colorectal and breast specimens). Quality of the specimen (Variable 13) This variable is obligatory to be used, only for cervical smears. Please add this variable and corresponding codes. Possible codes SUF+ SUF- INSU Meaning of the codes Sufficient, with endocervical cells Sufficient but without endocervical cells Insufficient (no reliable test result could be determined or the specimen could not be evaluated at all because it was broken or incorrectly labeled) Organ (Variable 14) Select the CODAP organ codes 64xx and 65xx. Please use organ codes with four characters. Make a clear distinction between cytology and histology. For cytology use organ codes 64CY of 65CY. CODAP page 14

15 Lesion (Variable 15): o BEFORE 2011: The test results of the cervical smears and biopsies of the year s 2008, 2009 and 2010 can be delivered as now available in your data base. o FROM 01/01/2011 ON: introduction of new lesion codes (CERVIBASE 2011) Several new lesion codes will be introduced. These new codes and their significance are mentioned in the table below. PLEASE ADD THESE NEW LESION CODES TO THE EXISTING CODAP 2007 CODES FROM 01/01/2011 ON. CERVIBASE 2011 NEW LESION CODES New codes Meaning of the code ONLY FOR CYTOLOGY NILM ASCU Negative for epithelial cell abnormalities or any malignancy Atypical squamous cells of undetermined significance ASCH Atypical squamous cells, cannot exclude HSIL LSIL Low-grade squamous intraepithelial lesion HSIL High-grade squamous intraepithelial lesion, incl. in situ AGLC Atypical glandular cells (no distinction between any favor or origin) ONLY FOR HISTOLOGY ABST CIN1 Absent: no squamous, glandular or any dysplasias nor tumour Mild dysplasia CIN2 Moderate dysplasia CGIN Endocervical glandular dysplasia CODAP page 15

16 o Systematic overview of CERVIBASE 2011 coding By coding the test results, take care to make a clear distinction between cytology and histology. For correct coding of the cervical smears (cytology) and biopsies (histology), please follow the systematic overview of diagnostic codes as mentioned below. THIS SYSTEMATIC OVERVIEW OF CERVIBASE 2011 CODES SHOULD BE APPLIED TO ALL SPECIMENS TAKEN FROM 01/01/2011 ON. MAKE A CLEAR DISTINCTION BETWEEN CYTOLOGY AND HISTOLOGY. POSSIBLE CODES FOR CYTOLOGICAL AND HISTOLOGICAL LESIONS CYTOLOGY Lesion code Meaning of the code No cell abnormalities NILM Negative for epithelial cell abnormalities or any malignancy Squamous cell abnormalities ASCU Atypical squamous cells of undetermined significance ASCH Atypical squamous cells, cannot exclude HSIL LSIL Low-grade squamous intraepithelial lesion HSIL High-grade squamous intraepithelial lesion (incl. in situ) CODAP 2007 Squamous cell carcinoma Glandular cell abnormalities AGLC Atypical glandular cells (no distinction between any favor or origin) CODAP 2007 Adenocarcinoma in situ CODAP 2007 Adenocarcinoma Other malignancies CODAP 2007 Any other malignancy HISTOLOGY Code Meaning of the code No cell abnormalities ABST No dysplasias nor tumour (absent) Squamous cervical lesions CIN1 Mild dysplasia (CIN1) CIN2 Moderate dysplasia (CIN2) CODAP 2007 Severe dysplasia (CIN3) CODAP 2007 Carcinoma in situ CODAP 2007 Squamous carcinoma Glandular cervical lesions CGIN Endocervical glandular dysplasia CODAP 2007 Adenocarcinoma in situ CODAP 2007 Adenocarcinoma Other malignancies CODAP 2007 Any other malignancy new lesion codes, to be used from 2011 in addition to the CODAP 2007 codes currently used CODAP 2007 lesion codes CODAP page 16

17 Degree of certainty (Variable 16): This applies to lesion and not HPV test. HPV high risk test results (Variable 17): select only one code HPV high risk test results: select only one code Possible codes Meaning of the codes HPV- Negative HPV+ Positive HPVi Inconclusive HPV high risk types detected (Variable 18) Possible codes Meaning of the codes HP16 HPV Type 16 HP18 HPV Type 18 HPxx HPV Type xx Multiple HPV types to be entered in a text field separated by com mas ",": Nomenclature number(s) (Variable 19) Please fill in the nomenclature number(s) associated with the corresponding specimens if known. In case of more than one nomenclature number, they should be entered separated by a comma (, ). Additional information about cervical smears For the cervical smears we want to know the following information: o o o Which method do you use to analyze the samples (conventional or liquid based)? What laboratory performs the HPV tests? Which test is used for HPV detection? This information should be communicated to the Belgian Cancer Registry by mail to following address: info@kankerregister.org or info@registreducancer.org CODAP page 17