CCC update. WHI Investigators Meeting May 7-8, 2015

Transcription

1 CCC update WHI Investigators Meeting May 7-8, 2015

2 Significant activities of the past year RFP and responses for Extension study Preparation for launching two new embedded trials

3 Significant activities of the past year Life and Longevity After Cancer (LILAC) Second mailing to previously enrolled participants Initial mailing to newly diagnosed cancers Medical records and tissue collection began Retention Mailing Letters from NHLBI Director Gibbons, RC and CCC PIs Brochure introducing the new embedded trials WHI 20 th anniversary commemorative medallion

4 Feasibility Study update Limited by compressed timeline Announced in December Approved by ASC in January, SC in February All costs incurred by August 31 Restricted to studies with no participant burden Lessons learned: Flow-down of contract requirements a surprise to some Direct purchase orders to labs allowed work to proceed while subcontracts were being negotiated

5 2015 Feasibility Studies Title PI Status Assessing sodium and potassium in 24-h and spot urines: feasibility of calibrating self-reported diet for use in WHI CVD association studies Lesley Tinker, FHCRC Specimens results back Longitudinal study of DNA methylation as a mediator between age and cardiovascular risk Targeted serum metabolites profiling in early detection of pancreatic cancer APOL1, sickle cell trait and chronic kidney disease in aging women Karen Conneely, Emory Li Jiao, Baylor College of Medicine Nora Franceschini, UNC Specimens delivered to the lab in mid-april. Specimens delivered to the lab in mid-april. Pulls 1-8 delivered. Pull 9 in process. Expect all to be delivered to the lab by May 31.

6 2015 Feasibility Study update Title PI Status Feasibility Study to Evaluate Haptaglobin Phenotype and Risk of CHD and Stroke among Older Diabetic Women Richard Donahue, SUNY at Buffalo Samples enroute to the lab in Israel. A pilot RNA-seq study among Long Life Study participants of the WHI A novel endogenous SERM and cholesterol metabolite, 27- hydroxcholesterol, and fracture risk in postmenopausal women Tim Assimes, Stanford Jennifer Lee, Stanford Samples to arrive at CCC on April 30, with delivery to lab in mid-may. Participant selection nearing completion. Hope to have samples processed and delivered to lab by May 31. Feasibility Study to Evaluate Gut Microbiome and CVD-related Measures in Older Women Michael LaMonte, SUNY at Buffalo Local specimens

7

8 #/type of studies using WHI biorepository and vials/10,000 pulled per year WHI Core BAA Ancillary # Vials pulled/10,000

9 Biorepository Inventory as of 4/8/15 Source Specimen Participants Vials WHI Buffy coat 146, ,811 WHI DNA Parent 104, ,447 WHI DNA Sub 57, ,141 WHI Citrate plasma 161, ,645 WHI EDTA plasma 161, ,161 WHI Red blood cells 159, ,289 WHI Serum 161,707 1,441,679 WHI Urine 11, ,901 WHI-HV 1 DNA Parent 7,314 14,409 WHI-HV EDTA plasma 7,308 76,968 WHI-HV EDTA PPT 2 7,382 57,952 WHI-HV Red blood cells 7,137 22,746 WHI-HV Serum SST 3 7,283 52,729 WHI-HV RNA Parent 7,241 14,479 1 HV (Home Visit) = collection at participant homes in (N~8,000) 2 PPT = Plasma preparation tube 3 SST = Serum separator tube

10 Selected outcomes with biospecimen Outcomes as of 8/29/14, specimen available as of 3/30/15 Outcome Incident cases 250 µl baseline serum 250 µl baseline EDTA plasma > 25 µg DNA or buffy coat Breast Ca 1 11,679 11,639 (99.7%) 11,467 (98.2%) 11,401 (97.6%) Colorectal Ca 2,835 2,826 (99.7%) 2,773 (97.8%) 2,758 (97.3%) Endometrial Ca 1,622 1,608 (99.1%) 1,592 (98.1%) 1,590 (98.0%) CHD 2 8,558 8,515 (99.5%) 8,381 (97.9%) 8,293 (96.9%) Stroke 6,418 6,393 (99.6%) 6,392 (99.6%) 6,176 (96.2%) Clinical MI 6,045 6,014 (99.5%) 5,910 (97.8%) 5,864 (97.0%) Hip Fracture 4,040 4,023 (99.6%) 3,966 (98.2%) 3,892 (96.3%) Pancreatic Ca (99.8%) 918 (97.9%) 906 (96.6%) Leukemia (99.0%) 843 (98.0%) 839 (97.6%) 1 Ca = Cancer 2 CHD = coronary heart disease

11

12 Access to Medicare data CMS approved access to WHI-linked Medicare data through a Virtual Data Enclave (VDE) Implementation awaiting NHLBI and CCC agreement regarding systems security plan and review process Based on approved manuscript or ancillary study proposal Plan for access Allows access to specific Medicare files required for approved proposal Denominator, MedPar (In-patient), Outpatient, Carrier, Home Health, Skilled Nursing, Hospice, Durable Medical Equipment Part D (prescription drugs, when available) Requires Separate data use agreement, signed by an institutional official Second approval by NHLBI and CCC VDE use fee

13

14 No changes Grab bars Decreasing clutter Increasing lighting Railings Non-slip surfaces Tacking down carpets/rugs Other Ramps Sink/counter heights Changes to Home (Total) Percent of Total (N=71,806)

15 50 Fall(s) at Home by Age 40 Percent (%) < Age at Start of Extension

16 Vaccines (Total) Flu shot past 12 months Pneumonia shot ever Shingles vaccine ever Percent of Total (N=71,806)

17 25 Glaucoma Ever by Race/Ethnicity 20 Percent (%) White Black Hispanic American Indian Asian/Pacific Islander Unknown

18 Eating Habits (Total) Eat alone most of the time Not able to shop, cook, feed Problems making it hard to eat Fewer than 2 meals per day Not enough money for food Percent of Total (N=71,806)

19 30 Not Able to Shop, Cook, Feed by Age 20 Percent (%) 10 0 < Age at Start of Extension

20 10 Not Enough Money for Food by Race/Ethnicity 8 Percent (%) White Black Hispanic American Indian Asian/Pacific Islander Unknown

21 Own cell phone Use a computer Use computer for Use computer internet Use internet for health info Send or receive text messages Use smart phone, ipad, device Looked at WHI website Phone and Computer Use (Total) Percent of Total (N=71,806)

22 15 Does Not Own Cell Phone by Race/Ethnicity 10 Percent (%) 5 0 White Black Hispanic American Indian Asian/Pacific Islander Unknown

23 80 Sends or Receives Text Messages by Age 60 Percent (%) < Age at Start of Extension

24 Cross-Cohort Collaboration Meeting WHI Attendees Karen Margolis, Marco Perez, Garnet Anderson, Jacques Rossouw, Barbara Howard Cohorts represented AGES, ARIC, CARDIA, CHS, FHS, HCHS/SOL, HealthABC, IRAS, JHS, MESA, MrOS, REGARDS, SHS, SOF, WHI Steering Committee with 1 member/1 alternate per cohort Chuck Eaton/Marco Perez Working groups to drive efforts, secure funding