Input from external experts and manufacturer on the 2 nd draft project plan Stool DNA testing for early detection of colorectal cancer

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1 Input externl experts nd mnufcturer on the 2 nd drft project pln Stool DNA testing for erly detection of colorectl cncer (Project ID:OTJA10)

2 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer Content EXTERNAL EXPERTS... 3 MANUFACTURER... 7 mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 2

3 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer EXTERNAL EXPERTS s were received : Nme Isel Idigors Ruio Eunte Arn-Arri Gerfried Lexer Bo Affilition Oskidetz, Spin BIOEF reserch Institute, Bsque Helth Service, Spin Registered physicin in surgery, Austri Hospitl, Oskidetz, Spin Eunte Arn- Arri Bsque Helth Service Idigors Oskidetz Eunte Arn- Arri Bsque Pge nd suggestion for rewording 8 87 I think it would e more interesting to mesure the result vrile efficiency insted of effectiveness. Besides detecting etter mlignnt nd premlignnt lesions, DNA stool is more efficient? On the other hnd, the term sfer must e considered within the complictions of screening progrm (complictions of colonoscopies, psychologicl dmge,...) ut not flse results. Chrcter of mjor =1 minor = 2 1 We don t ssess efficiency (tht would relte to the ECO domin) within this REA. Second sentence not quite cler we ssess sfety, primrily, of the test itself, not of the whole screening pthwy including the test nus nd nl cnl should not eing considered CRC 2 Thnks, corrected (Tle 2-5; Popultion) I do not think it is pproprite to estimte risk: greter or equl to 5 denoms or denoms greter thn or equl to 20 mm. 1 Sentence hs een modified. mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 3

4 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer Helth Service Dr.med.univ. Gerfried Lexer Pge nd suggestion for rewording These re premlignnt lesions tht must e detected in screening progrm As fr s I know in Germny colonoscopy in prevention colorectl cncer strts with the ge of 55. In Austri we strt with the ge of 50. Women nd men t the sme ge. As we know tht CRC in men occur erlier the society of gstroenterology recommend strting ge 45. As we know tht the Adeno Crcinom growing time is etween 10 nd 15 yers I urgently recommend screening strt t lest with the ge of 40 in men - nd - 45 in women. Within this time oncogenes get more in s so they cn get ctched during this time period s precncerous signs efore the cncer is histologiclly dignosed. I recommend strting with 40/45 yers. Chrcter of mjor =1 minor = 2 1 During the scoping phse we lredy discussed the strting ge tht should e defined within PICO nd so fr greed on sticking to the recommendtions pulished in Europe. Plese give the exct sources for your s nd recommendtions (cittion or pdf) so we cn reconsider. Answer expert: Americn cncer society: CA:A Cncer Journl for Clinicins (2018;doi: /cc.21457) uthors: For the definition of the generl trget popultion of the ssessment (i.e. typicl screening popultion) the ge ws modified to 45 yers or older ccording to the recently pulished recommendtions of the Americn cncer society. Dr.med.univ A mjor prolem of colonoscopy s it is sujective investigtion 1 Mny thnks for the relevnt mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 4

5 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer Gerfried Lexer Bo Hospitl Oskidetz Bo Hospitl Oskidedtz Bo Hospitl Oskidedtz Bo Pge Tle 2-5 Screening polupltion Tle 2-5 Polultion: Screening for colorectl cmcer (CRC) nd precncerous lesions Tle 2-5 Popultion: Screening for colorectl cmcer (CRC) nd precncerous lesions Tle 2-5 nd suggestion for rewording re the undetected pthologies - which re responsile for the so-clled Intervll crcinoms. A DNA Test is like in criminology ojective testing. High risk for CRC: I recommend defining fmily history of high risk only one first degree reltive (FGR) under 60 yers or two FDR ges 60 or more. D01-. Is etter to define s high grde dysplsi for the term crcinom in situ K63.5 Polyp of colon Incl: serrted polyps I recommend dividing serrted polyps in sessile serrted denom nd trditionl serrted denom. Numer needed to screen must e divided in two trgets: to detect colorectl cncer nd dvnced denom Chrcter of mjor =1 minor = 2. 1 Added 1 We do not wnt to chnge the wording here, s D01 Crcinom in situ is the term used in WHO ICD Hs een dded. 1 Hs een dded. mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 5

6 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer Hospitl Oskidedtz Idigors Oskidetz Idigors Oskidetz Eunte Arn- Arri Bsque Helth Service Idigors Oskidetz Pge Outcomes: Effectiveness nd suggestion for rewording The cut off for Positivity of Fecl immunochemicl test (FIT) should e clrified s it is different for eing referred to colonoscopy round the different screening progrmmes round Europe Rtionle: ccording to Europen Guidelines (2012) should e editor (Tle 2- In the security I do not think it is pproprite to include: 5; Outcomes) - flse negtive rte for CRC / precncerous lesions - flse positive rte for CRC / precncerous lesions - negtive predictive vlue These re efficcy dt. Sfety is the complictions derived the progrm (psychologicl dmge, complictions of colonoscopies, complictions of surgeries,...) The errors of the test should e nother nd neither re progrm sfety Chrcter of mjor =1 minor = 2 1 Mny thnks of course vlid point. The cut off will e extrcted (see lso tle 2-4) nd results will e interpreted ccordingly. 1 Thnks, corrected. 1 We ssess sfety, primrily, of the test itself, not of the whole screening pthwy tht includes the test. We gree with regrd to flse negtive nd flse positive rtes eing (lso) efficcy dt, ut for resons of clerness wnt to hve them mentioned in the sfety. The other mentioned outcomes (errors of the test) hve een moved to other outcomes REFERENCE: Frist edition ; typing error FIRST 3 Thnks, corrected. mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 6

7 All s nd uthor s replies on the 2nd drft project pln Stool DNA testing for erly detection of colorectl cncer MANUFACTURER s were received : Nme Philipp Freese, Moritz Eidens Compny PhrmGenomics GmH Pge Line or nd suggestion for rewording Chrcter of mjor =1 minor = 2 PhrmGenomics Generl Everything is fine for us no s! Thnk you. mjor : the points to highly relevnt spect nd thorough nswer is expected the uthor(s) minor : the does not necessrily hve to e nswered in detiled mnner c linguistic : grmmr, wording, spelling or comprehensiility 7

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