1 / 30

The Feasibility of Routine Surveillance of Preinvasive Cervical Cancer in Louisiana

This study aims to determine if it is feasible to resume the collection of preinvasive cervical cancer cases in Louisiana using the existing registry infrastructure. The data collected will be used to assess the impact of the HPV vaccine on cervical cancer rates.

constancej
Télécharger la présentation

The Feasibility of Routine Surveillance of Preinvasive Cervical Cancer in Louisiana

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. The Feasibility of Routine Surveillance of Preinvasive Cervical Cancer in Louisiana Louisiana Tumor Registry Tara Ruhlen, MPH Vivien Chen, MPH, PhD Edward Peters, DMD, SM, ScD

  2. Background & Objectives • HPV Vaccine • Will significantly reduce rates of cervical cancer and pre-cancerous lesions • Baseline data is required, however, to measure the impact • Heightened interest in looking at CIN3 rates • Preinvasive — shorter time period before observing outcome • Intermediate biomarker • Is it feasible for Louisiana to resume the collection of CIN3 cases using the existing registry infrastructure?

  3. Louisiana CIN3 Background • Prior to 1996, Louisiana collected CIN3 cases • Collection stopped due to issues of burden and comparability • State law amended to exclude the reporting of CIN3 cases to the registry • Estimated that there are 1282 cases of CIN3 annually in Louisiana • Based on case counts from 2005 to 2006 data and ratio of cervical cancer to CIN3

  4. CIN3 Surveillance Project — Eligibility • Site (ICD-O-3) • C53.0 (endocervix) • C53.1 (exocervix) • C53.8 (overlapping lesions of cervix uteri) • C53.9 (cervix uteri) • Behavior • 2 (in situ or noninvasive) • Pathologic Classification • CIN III, CIS, AIS, Severe Dysplasia • Case Enrollment Period (Dx Date) • July 1, 2008 to December 31, 2009 • Catchment area • Residents of Louisiana at time of diagnosis (includes cases diagnosed out of state) • Histology • 8010/2 Carcinoma in situ, NOS • 8050/2 Papillary carcinoma in situ • 8052/2 Papillary squamous cell carcinoma, non-invasive • 8070/2 Squamous cell carcinoma in situ, NOS • 8071/2 Sq. cell carcinoma, keratinizing, NOS, in situ • 8072/2 Sq. cell carcinoma, lg. cell, non-ker., in situ • 8076/2 Sq. cell carcinoma, in situ with questionable stromal invasion • 8077/2 Squamous intraepithelial neoplasia grade III • 8140/2 Adenocarcinoma in situ

  5. CIN Surveillance Project — Variables • Patient Name (first, last) • Patient Address (city, state, parish) • Sex • Date of Birth • Date of Diagnosis • Age at Diagnosis • Race 1 • Spanish Origin 1 • Spanish Origin 2 • Original Reporting Facility • Follow-up Reporting Facility • Type of Reporting Source • Site • Behavior • Histology • Comments • Histology Terminology Code • 1 = AIS • 2 = CIN3 • 3 = CIS • 4 = Severe Dysplasia *Collecting abbreviated abstract with only required CIN study variables*

  6. Louisiana CIN3 Reporting • Looked at current methods for reporting cancer cases in the state, and adapted methods for CIN3 collection • Rapid Case Ascertainment • 30-60 days after date of diagnosis • Mechanisms for case reporting: • Electronic reporting from pathology labs • Screening pathology labs by central registry • WebPlus • Mail/Fax

  7. Reporting Mechanism #1: E-Path • Electronic Pathology (E-Path) • 40% of total cases reported from hospital or private pathology lab in LA reported by E-Path • Created minor changes in selection criteria to allow for the CIN3 reporting • Expanded criteria slightly so that all cases with possible inclusion would be reviewed • Cases are imported into SEER*DMS

  8. Reporting Mechanism #2: Screening • Central Staff pathology screening • Cases submitted into data management system • Customized special study criteria that searches for key terms and flags case for manual review

  9. Reporting Mechanism #3: WebPlus • Collects cancer data securely over the internet • Hospital registrar manually inputs data through reporting activity in the program • Reporting form designed specifically for the project and includes only necessary fields • Once entered, data collected by central registry and imported into database

  10. Reporting Method #4: Mail/Fax • Paper Pathology Reports • Requested reports and matching face sheets to be sent to LTR • Face sheets exclude need for follow-up to obtain demographic information • Case Entry Form • Scannable paper form for use in the field • Form sent back to LTR then transferred to the Epi Data Center for scanning and verification • Data is verified and automatically entered into database

  11. Preliminary Data from Louisiana Reporting activity through June 12, 2009

  12. # of Eligible CIN3 Cases Reported by Month of Diagnosis

  13. How are the cases being reported?

  14. Incomplete Records

  15. # of Eligible CIN3 Cases — Age at Diagnosis 50% of eligible cases in Louisiana are between ages 20 and 29

  16. Race

  17. Site & Histology of Eligible Cases Site Codes Histology

  18. Barriers to CIN3 Reporting

  19. Barriers – Louisiana State Law § Cancer Case Reporting. A. Reportable Cancer Cases. Any newly diagnosed in situ or invasive neoplasm is considered a reportable diagnosis (these bear a behavior code of “2” or “3” in the International Classification of Diseases for Oncology, 2nd edition (1992) or 3rd edition (2000), published by the World Health Organization. The two exceptions are: (1) carcinoma in situ of the cervixor prostate intraepithelial neoplasia and (2) basal cell and squamous cell carcinomas of the skin unless they occur on the vermillion border of the lips or on the genital organs. In addition, the following tumors shall be considered reportable: juvenile astrocytoma (ICD-O-3 code M-9421/1); tumors with a behavior code of “0” (benign) or “1” (borderline) if diagnosed at ICD-O-3 anatomical sites C70.0-C72.9 or C75.1-C75.3; and other histologies mandated by funding agencies. Louisiana Register – December 2004 issue

  20. Possible Solution to State Law “C. Variables to be Reported 2. …Additional variables may be added to the list as they are needed to study Louisiana-specific cancer questions or as they are required by LTR funding agencies. The Louisiana Tumor Registry or its regional offices may require that other data be abstracted and reported.” This section of the law allows the CIN3 project to be deemed an extension of routine surveillance

  21. Barriers — IRB • LSUHSC IRB and the CDC IRB have deemed project to be EXEMPT • Wanting to consider this an extension of routine registry surveillance • Yet, facilities are wanting to have own IRB completed • Full abstract is not required and the length of time for reporting has been shortened (from 6 month to 30 days) • Therefore, this project feels much different than routine casefinding and surveillance activity and, as a result, must be different • Time delay! Should be focusing on collecting cases

  22. Barriers - Resource Issues • Hospital Registry • Since Hurricane Katrina, many hospitals lost their registrars because of budget cuts and transfers • Number of staff workers reduced, but workload increased • “Must do more with less” • First priority is ROUTINE case finding and abstraction • Time involved in abstracting cases or filling in forms (WebPlus or scan) for CIN3 project is too extensive • Because this is not routine, “coverage of cases will be spotty”

  23. Barriers — Resource Issues • Central Registry • Study coordinators provided stacks of paper pathology reports to sort through to find cases • Many of the records are not cervical in nature • Missing demographic information on pathology reports = case follow-back • 72% of paper pathology reports sent to LTR have no demographics • 74% of electronic pathology reports are missing race and/or address

  24. Possible Solution to Staffing Issues • Suggested to contact hospital pathology labs directly (after informing hospital abstractors) to allow central registry staff to screen for CIN cases • Pathology labs may be able to generate list of CIN cases to review by searching for eligible terms • Similar to process in Kentucky • Created a new system of reporting that receives data directly from the pathology labs to obtain the CIN case information

  25. Lessons Learned

  26. Rapid Case Finding? E-Path • Allows for case identification within 60 days • Reports are given on the 1st of each month for previous month • Although timely, cases not usually complete • Select hospitals in the state contain address, but not race • Other labs have no demographics or race/ethnicity provided

  27. Rapid Case Finding? E-Path • Requires extensive manual review to determine eligibility • The use of multiple terms • SEVERE SQUAMOUS DYSPLASIA (CIN III) • SQUAMOUS CELL CARCINOMA IN SITU AND HPV CYTOPATHIC EFFECT (CIN III) • SEVERE SQUAMOUS DYSPLASIA/CARCINOMA IN SITU (CIN III/CIS) • CIN2/CIN3 (MODERATE TO SEVERE DYSPLASIA) • Diagnostic tests – study excluded cytology only diagnosis (i.e. Thin Prep) • Site: Cervical Lymph Node • 2503 records in the system that have been reviewed or are flagged for review

  28. Rapid Case Finding? Hospital Registrar • Reports sent in a rapid fashion • Most cases sent within 60 days of diagnosis date • Usually paper pathology report and face sheet to central office • Some have been using the scannable form • Not a full abstract, or even abstractions • Mostly just casefinding and leaving the abstraction to LTR coordinators • Coding of variables (histology term) is accurate when compared to the pathology report • Eligible case? • Cases sent quickly many times are not eligible cases • Sending in lots of CIN2/3, moderate dysplasia • Not necessarily that registrar finds case to fit in study criteria – it that it’s a dysplasia case

  29. Recommendations • Make CIN3 a reportable diagnosis • National Standard Setters • State law • If part of routine work, data will be collected • Clarify case definition • Need a clear-cut definition consistent with terms used in pathology labs • Further training may be required as to sort through inconsistent terminology • Utilize standard format • NAACCR record • Currently, data is sent using methods where full abstraction is not required

  30. Questions? Tara Ruhlen, MPH Louisiana Tumor Registry 1615 Poydras St, Ste 1400 New Orleans, LA 70112 (504)568-5770 (p) truhle@lsuhsc.edu

More Related