Overview of the PPMI Widespread Recruitment Initiative. Tatiana Foroud Indiana University Genetic Coordination Center (GCC)
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1 Overview of the PPMI Widespread Recruitment Initiative Tatiana Foroud Indiana University Genetic Coordination Center (GCC)
2 G-PPMI: Widespread Recruitment MJFF and the Genetic Coordination Core (GCC) developed paired websites to screen large numbers of individuals for the key LRRK2 mutations
3 G-PPMI: Widespread Recruitment Individuals pre-screened on MJFF website Read basic information about LRRK2 and PD Sent to IU website to complete IU Informed Consent Process
4 MJFF website
5 GCC-WRI website
6 Who has completed the WRI screening process?
7 WRI Screening Questions Yes: 265 No: 259 Yes: 53 No: 432 Unknown: 39 Yes: 415 No: 73 Unknown: 36 Yes: 1 No: 92 Unknown: 4 (newer question) Father: 151 Mother: 120 Sibling: 65 Children: 10 Yes: 43 No: 126 Unknown: 355
8 G-PPMI: Widespread Recruitment Individuals pre-screened on Fox website Provide basic demographic information Read basic information about LRRK2 and PD Complete screening questions Sent to IU website to complete IU Informed Consent Process risk for LRRK2 mutation: qualify for saliva kit risk for LRRK2 mutation: do not qualify for saliva kit
9 WRI- Saliva kit
10 Who has qualified for a saliva kit?
11 G-PPMI: Widespread Recruitment Saliva kit sent by GCC to those at risk for LRRK2 mutation Saliva kit sent by GCC to MGH for testing Subject fills saliva kit and mails back to GCC at Indiana University Results returned to GCC; GCC Genetic Counselor counsels subject by phone LRRK2+ subjects referred to PPMI site for screening
12 WRI Update Qualified and Confirmed 381 Sent Kit 381 Kit returned and sent to MGH 281 Kits outstanding 100 Results returned 229 Positive 28 Negative 201 Pending 52 Pending confirmation of qualification 22 Do not qualify 90
13 Currently, we have identified 28 LRRK2+ individuals from the 229 subjects who have results 12.2% rate of LRRK2+ (12.1% in PD, 12.4% in unaffected)
14 Who is testing positive for a LRRK2 mutation? In the WRI recruitment, of the 28 LRRK2+ individuals 96.4% AJ 23 (82.1%) have 1 relative with PD For 20 of the 23, the relative is a parent At the PPMI site, PD and Movement Disorders Center of Boca Raton: 8% of unaffected AJ subjects with a 1 st degree relative with PD are LRRK2+
15 Previous Genetic Testing Individuals can also come to the WRI website if they have previous genetic testing There is a question in the survey asking if genetic testing has been done Individuals who respond affirmatively are asked to send in their results Genetic counseling is offered
16 Previous Genetic Testing Number of individuals reporting previous genetic testing results Number of individuals who have sent in their genetic testing results so far Number of individuals who after review were confirmed to be LRRK2+ Number of individuals already referred to or waiting for a PPMI site Waiting to refer to a PPMI site
17 WRI Referrals to PPMI Sites Site # WRI Referred Cohort PD* Cohort Unaffected* Registry PD* Registry Unaffected* Columbia University Baylor College of Medicine The Parkinson s Institute University of Pennsylvania 1 1 University of California San Diego Boston University Northwestern University Sun Health Research Institute Total * Subject referred for this arm; enrollment pending for most 44 LRRK2+ individuals identified through WRI 16 with previous LRRK2+ test 28 found through genetic testing
18 Subject participates in Widespread Recruitment Initiative at GCC Subject LRRK2+ Subject LRRK2- GCC completes referral to PPMI site: Cover sheet Subject information & unofficial study arm assignment GCC genetic counseling checklist Genetic mutation testing form (GMU)
19 The Successful Transfer to a Site is Key!
20 The Successful Transfer to a Site is Key!
21 Funnel Filling through WRI MJFF Website: 1329 Complete the online survey 581 meet initial criteria GCC-WRI Website: 493 complete the online survey 381 meet the criteria to receive a saliva kit 281 return the filled saliva kit 28 LRRK2+ 15* referred to site *+16 with previous genetic test
22 What next for the PPMI site? The PPMI site enters the Genetic Mutation Testing form into eclinical GCC enters genetic testing result into eclinical Study arm assignment algorithm runs Site receives an automated confirming the study arm assignment
23 What next for the PPMI site? PPMI site contacts the subject Discusses the study and study arm assignment Schedules screening visit After speaking with the subject, the PPMI site Completes the bottom portion of the Genetics Referral form PPMI site faxes the Genetics Referral form back to the GCC
24 What s next for the GCC and WRI? Family History Substudy Identify related individuals participating in PPMI GCC sends Family History Substudy packet to all WRI LRRK2+ individuals Reduces the burden on the site Allows GCC to ask the subject to share LRRK2 family brochure with family members
25 Subject participates in Widespread Recruitment Initiative Subject LRRK2+ Subject LRRK2- GCC completes referral to PPMI site: Cover sheet Subject information & study arm assignment GCC genetic counseling checklist GMU GCC sends Family History Substudy packet and LRRK2 Family Brochures Subject sends Family History Questionnaire back to GCC; Subject sends LRRK2 Family Brochures to relatives
26 PPMI Genetics Operations Manual The updated manual is now available and includes: Widespread Recruitment Initiative (pages 10 and 11) Updated procedures and forms
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