INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG CANCER Prospective Mesothelioma Staging Project

Transcription

1 INTERNATIONAL ASSOCIATION FOR THE STUDY OF LUNG CANCER Prospective Mesothelioma Staging Project Data Forms and Fields in CRAB Electronic Data Capture System - Reduced Set - Pivotal data elements for developing proposals for change to the 8 th edition of TNM as of July 7, 2013 Last revised

2 Contents PATIENT CHARACTERISTICS... 2 DISEASE DESCRIPTION AT DIAGNOSIS... 4 PRE-TREATMENT TNM... 6 PRE-TREATMENT ASSESSMENT OF PLEURAL THICKNESS AND PRESENCE OF EFFUSIONS... 7 PRE-TREATMENT ASSESSMENT OF DIRECT INVASION... 8 PRE-TREATMENT ASSESSMENT OF DIRECT INVASION... 9 PRE-TREATMENT ASSESSMENT OF NODAL INVOLVEMENT PRE-TREATMENT ASSESSMENT OF DISTANT METASTASIS TREATMENT POST-SURGICAL TNM POST-SURGICAL ASSESSMENT OF DIRECT INVASION POST-SURGICAL ASSESSMENT OF NODAL INVOLVEMENT POST-SURGICAL ASSESSMENT OF DISTANT METASTASIS FOLLOW-UP PATIENT CHARACTERISTICS Page 2

3 1-Male 2-Female 3-No Data Sites may elect to provide only year of birth or provide the age at diagnosis (located on the Disease Description at Diagnosis ecrf) in lieu of birth year if this is a requirement for release of the data by the local ethics review board. Substituting age at diagnosis for birth date or year is not advisable for sites which intend to export and analyze their data locally. 1-Asian 2-Black or African America 3-White or Caucasian 4-America Indian/Alaskan Native/Pacific Islander 5-Other /Mixed/Uncertain Note: The reason that hispanic or latino origin does not appear in the drop-down menu is that these terms describe ethnicity rather than race. Page 3

4 DISEASE DESCRIPTION AT DIAGNOSIS 1-Yes 2-No Date of pathologic diagnosis is a derived variable which is equal to: 1) the date of histology if histologic proof of malignancy is obtained or 2) the date of cytology, if the diagnosis is based on solely on cytologic proof of malignancy. If data are being submitted in batch rather than through the EDC, the data contributor may elect to provide year only for the date of diagnosis and to provide "delta times" (days elapsed since the date of diagnosis) for all other date fields. 1-Right 2-Left 3-Bilateral 4-No data The date of histologic proof of malignancy will be considered the date of pathologic diagnosis except when histology was not obtained. In that case, date of cytology will be used. Page 4

5 DISEASE DESCRIPTION AT DIAGNOSIS If Histologic Type/Subtype is malignant mesothelioma, NOS or Other, these fields will be enabled. 1-Localized 2-Diffuse 4-Not Applicable 1-Diffuse malignant mesothelioma: Epithelioid mesothelioma 2-Diffuse malignant mesothelioma: Sarcomatoid mesothelioma 3-Diffuse malignant mesothelioma: Desmoplastic mesothelioma 4-Diffuse malignant mesothelioma: Biphasic mesothelioma 5-Diffuse malignant mesothelioma: NOS 6-Localized malignant mesothelioma: Epithelioid mesothelioma 7-Localized malignant mesothelioma: Sarcomatoid mesothelioma 8-Localized malignant mesothelioma: Desmoplastic mesothelioma 9-Localized malignant mesothelioma: Biphasic mesothelioma 10-Localized malignant mesothelioma: NOS 11-Well differentiated papillary mesothelioma 12-Malignant mesothelioma, NOS 13-Other 14-No data 1-Yes 2-No Page 5

6 PRE-TREATMENT TNM Page 6

7 PRE-TREATMENT ASSESSMENT OF PLEURAL THICKNESS AND PRESENCE OF EFFUSIONS 1-Minimal 2-Rind-like 3-Nodular 4-No data 2-Yes, non-calcified 3-Yes, calcified 4-Yes, calcification not specified 5-No data Please see protocol section 10.3 for instructions on measuring maximal pleural thickness. 1-Positive 2-Negative ne 2-Present, right side 3-Present, left side 4-Present, both sides 5-Present, side not specified 6-No data 2-Yes, non-calcified 3-Yes, calcified 4-Yes, calcification not specified 5-No data Page 7

8 PRE-TREATMENT ASSESSMENT OF DIRECT INVASION Use this button to answer no to all invasions Indicate no data or unknown to all invasions Unless otherwise specified, choices are: 2-Yes 2-Pleura and endothoracic fascia only 3-Fascia and chest wall muscle 4-Fascia, chest wall muscle, and ribs 5-Yes, no further data 6-No data 1-Single focus 2-Confluent tumor ne 2-Single focus 3-Diffuse or multifocal 4-Yes, no further data 5-No data Page 8

9 PRE-TREATMENT ASSESSMENT OF DIRECT INVASION Unless otherwise specified, choices are: 2-Yes Use this button to answer no to all questions in this box. Indicate no data or unknown to all questions in this box. 2-Possible 3-Yes 4-No data 2-Mediastinal fat 3-Mediastinal organs 4-No data 2-Possible 3-Probable 4-Definite 5-Transmural 6-No data Page 9

10 PRE-TREATMENT ASSESSMENT OF NODAL INVOLVEMENT 1-IASLC None Individual results need not be entered if not examined is checked. + = At least one node examined in this region was considered to be metastatic - = All nodes examined in this region were considered to be nonmetastatic ND = No node examination done in this region or results were equivocal (none considered metastatic) Page 10

11 PRE-TREATMENT ASSESSMENT OF DISTANT METASTASIS Entered on Pre-Treatment TNM Page 1-Absent 2-Single 3-Multiple 4-Present 5-No data 1-Yes, resected 2-Yes, biopsied, positive for malignancy 3- Yes, biopsied, negative for malignancy 4-No 5-No data Page 11

12 TREATMENT ne 2-Exploration, no pleurodesis 3-Exploration, pleurodesis only 4-Partial pleurectomy 5-Pleurectomy/decortication 6-Extended pleurectomy/decortication 7-Extrapleural pneumonectomy 8-Other 9-No data Page 12

13 TREATMENT ne 2- Median Sternotomy 3-Thorocotomy 4-VATS 5-No data 1-Yes 2-No 1-R1 (Microscopic residual tumor) 2-R2 (Macroscopic residual tumor) * Please note: R0 (Microscopically complete resection) is not listed as a choice due to the view that microscopically complete resection of MPM is highly unlikely. ne 2-Segmentectomy 3-Wedge Resection 4-Lobectomy 5-Bilobectomy 6-Pneumonectomy 7-Other 8-No data Page 13

14 TREATMENT 1-Surgery 2-Systemic therapy 3-Radiation therapy 4-Radiation and systemic therapy 5-None 6-No data Page 14

15 POST-SURGICAL TNM The data entry system will prompt the user to complete post-surgical forms only if the final surgical procedure is described on the Treatment form as one of the following choices: 2- Exploration, no pleurodesis (no resection) 3-Exploration, pleurodesis only (no resection) 4-Partial pleurectomy 5-Pleurectomy/decortication 6-Extended pleurectomy/decortication 7-Extrapleural pneumonectomy 8-Other Post-Surgical forms include: Post-Surgical TNM Post-Surgical Assessment of Direct Invasion Post-Surgical Assessment of Nodal Involvement Post-Surgical Assessment of Distant Metastasis Note that findings from any surgery other than pleurodesis alone or a strictly diagnostic procedure will be recorded on Post-Surgical ecrfs. Findings from pleurodesis alone or strictly diagnostic procedures will be recorded on Pre-Treatment ecrfs. Page 15

16 POST-SURGICAL TNM The system calculates Overall Stage based the T, N, and M as entered on above. Page 16

17 POST-SURGICAL ASSESSMENT OF DIRECT INVASION Unless otherwise specified, choices are: 2-Yes Entered on Post-Surgical TNM Page 1-Single focus 2-Confluent tumor 2-Single focus 3-Diffuse or multifocal 4-Yes, no further data 5-No data 2-Pleura and endothoracic fascia only 3-Fascia and chest wall muscle 4-Fascia, chest wall muscle, and ribs 5-Yes, no further data Page 17

18 POST-SURGICAL ASSESSMENT OF DIRECT INVASION Unless otherwise specified, choices are: 2-Yes Indicate no data or unknown to all questions in the box below. Indicate no data or unknown to all questions in the box below. 2-Mediastinal fat 3-Mediastinal organs 4-No data 2-Yes, non-transmural 3-Yes, transmural 4-Yes, no further data 5-No data Page 18

19 POST-SURGICAL ASSESSMENT OF DIRECT INVASION 1-Yes 2-No ne 2-Present, right side 3-Present, left side 4-Present, both sides 5-Present, side not specified 6-No data 2-Muscle only 3-Muscle plus adjacent peritoneum 4-Muscle plus adjacent peritoneum plus adjacent abdominal organ 5-Muscle plus diffuse peritoneal, no ascites 6-Muscle plus diffuse peritoneal with ascites 7-Yes, no further data 8-No data 1-Positive 2-Negative 2-Yes, with positive cytology 3-Yes, with negative cytology 4-Yes, without cytology results 5-No data Page 19

20 POST-SURGICAL ASSESSMENT OF NODAL INVOLVEMENT Entered on Post-Surgical TNM Page Page 20

21 POST-SURGICAL ASSESSMENT OF DISTANT METASTASIS Entered on Post-Surgical TNM Page 1-Absent 2-Single 3-Multiple 4-Present 5-No data 1-Yes, resected 2-Yes, biopsied, positive for malignancy 3- Yes, biopsied, negative for malignancy 4-No 5-No data 2-Yes Page 21

22 FOLLOW-UP 1-Alive 2-Dead 3-Lost to follow-up 4-No Data Page 22