-
Notifications
You must be signed in to change notification settings - Fork 0
/
Copy pathconnectStudy.txt
164 lines (122 loc) · 8.37 KB
/
connectStudy.txt
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
Connect for Cancer Prevention Study
The Connect for Cancer Prevention Cohort StudyExit Disclaimer is a new prospective cohort of 200,000 adults in the United States designed to further investigate the etiology of cancer and its outcomes, which may inform new approaches in precision prevention and early detection. The new cohort capitalizes on research innovations to advance the field of cancer epidemiology and prevention including:
New technologies for exposure assessment (e.g., tracking and sensors to measure behavior and environment);
Large-scale analyses of the genome, epigenome, transcriptome, proteome, metabolome, microbiome;
Molecular profiling of tumors and precursor lesions.
Overview of Study Setting and Design
The Connect for Cancer Prevention Study (“Connect”) is being conducted within a set of integrated health care systems to recruit 200,000 members or patients between the ages of 30-70 years with no personal history of invasive cancer (other than non-melanoma skin cancer at the time of recruitment), based on an NIH IRB-approved protocolExit Disclaimer. Recruitment efforts are aimed to promote participation of individuals from diverse backgrounds and geographic areas.
Consented participants are asked to complete an online questionnaire at baseline and periodically throughout the duration of follow-up, as well as provide access to their electronic medical records (EMRs). Blood, urine, and saliva samples are collected at baseline and repeatedly during follow-up. During follow-up, serial biological specimens as well as new specimens, including tissue specimens, are collected. Passive follow-up via tumor registries and EMRs provides outcome information for cancers and their precursors.
Communication and coordination of study activities occur electronically through a participant application (“app”) available for desktop or mobile devices. This state-of-the-art cohort is built with an efficient, flexible, and integrated infrastructure designed to make the most of modern interoperability standards in order to serve as a research resource for future generations of scientists at the NCI and across the broader scientific community.
Connect is supported by the NIH Intramural Research Program.
Initial contracts for study recruitment were awarded to the following healthcare institutions:
HealthPartners, Minneapolis, MN
Henry Ford Health, Detroit, MI
Kaiser Permanente Colorado, Denver, CO
Kaiser Permanente Georgia, Atlanta, GA
Kaiser Permanente Hawaii, Honolulu, HI
Kaiser Permanente Northwest, Portland, OR
Marshfield Clinic Health System, Marshfield, WI
Sanford Health, Sioux Falls, SD
University of Chicago Medical Center, Chicago, IL
Timeline
Recruitment through the partnering health care institutions was launched in 2021 and will continue through 2026. Serial questionnaires, biospecimen collection, EHR data collection, data linkages and passive follow-up activities will occur during the duration of the study, which is expected to be for decades. Visit the participant recruitment website.
Study Team
Coordinating Center for the Connect for Cancer Prevention Study
Mia Gaudet, Ph.D., Senior Scientist
Nicolas Wentzensen, M.D., Ph.D., M.S., Principal Investigator
Marie-Josèphe Horner, Ph.D., Staff Scientist, Lead of Scientific Development
Scientific Development Working Groups
Connect assets have been developed by investigators at DCEG and the broader scientific community. The Study Team is grateful for these contributions that have led to the study protocol:
Breast Cancer Screening
Scope
Develop protocol for transferring images, pilot protocol, consider self-reported survey module
Leadership
Gretchen Gierach, Ph.D., M.P.H.
Diet
Scope
Implementation of Diet History Questionnaire (DHQ) at six months and ASA24 at 12 months post-enrollment; return of results
Leadership
Erikka Loftfield, Ph.D., M.P.H.
Electronic Medical Records
Scope
Define technical details of transfer, frequency, replace data
Leadership
Megan Clarke, Ph.D., M.H.S. (lead); Toniya Brown and Aileen Cunnane (CCC coordinators)
Genome-Wide Association Studies (GWAS)
Scope
Develop ancestral algorithm, return of results and approach, oversight of QC metrics, display of data at multiple layers of access
Leadership
Mitchell Machiela, Sc.D, M.P.H. (lead); Dominique Hopkins (CCC coordinator)
Liquid Biopsy
Scope
Develop protocol for serial biospecimen collection for future assays; define study participants of interest; develop complementary data collection
Leadership
Dr. Wentzensen (lead; CGB), Ms. Hopkins (CCC coordinator)
Microbiome
Scope
Develop protocol for stool collection during follow-up and microbiome assays; obtain funding for entire cohort; return of results
Leadership
Emily Vogtmann, Ph.D., M.P.H. (lead), Dr. Horner (CCC coordinator)
Precursor Ascertainment (Benign Breast Biopsies and Colorectal Adenomas)
Scope
Develop an algorithm for the ascertainment of prevalent and incident precursor lesions, starting with benign breast biopsies and colorectal adenomas.
Leadership
Dr. Clarke (lead), Ms. Cunnane (CCC coordinator)
Rapid Case Ascertainment
Scope
Develop rapid case ascertainment algorithm and define technical details of data transfer
Leadership
Dr. Clarke (lead), Ms. Cunnane (CCC coordinator)
Surveys: Cancer Screening History
Scope
Develop surveys related to cancer site-specific screening, diagnostic modality, and symptoms
Leadership
Dr. Neal D. Freedman (lead; DCCPS – TCRB), Julie Cusack (CCC coordinator)
Surveys: Cancer Survivorship
Scope
Develop survey timing and frequency relative to diagnosis and content
Leadership
Dr. Freedman (lead; DCCPS – TCRB), Ms. Cusack (CCC coordinator)
Surveys: Hair Products
Scope
Develop survey on hair straighteners, relaxers, colorants, and windows of exposure over the life-course
Leadership
Stella Koutros, Ph.D., M.P.H. (lead), Dr. Katie O'Brien (co-lead), Ms. Cusack (CCC coordinator)
Surveys: Menstrual and Intimate Care Products
Scope
Develop survey on menstrual and intimate care products and windows of exposure over the life-course
Leadership
Dr. O'Brien (lead), Ms. Cunnane (CCC coordinator), Ms. Cusack (CCC coordinator)
Surveys: Naphthalene and Scented Products
Scope
Develop survey on household exposures to naphthalene-containing products (e.g. mothballs) and other scented household products
Leadership
Sonja Berndt, Pharm.D., Ph.D. (lead); Ms. Cusack (CCC coordinator)
Surveys: Structural and Social Determinants of Health
Scope
Develop conceptual model and measures of social inequities, including structural racism, built and social environment, social cohesion, and social capital
Leadership
Wayne Lawrence, Dr.P.H., M.P.H. (lead), Dr. Joseph (co-lead), Aleah Thomas, B.S. (CCC Coordinator)
Members
Dr. Lawrence (co-lead)
Christine Joseph, Henry Ford Health (co-lead)
Ms. Thomas (CCC coordinator)
Madina Agénor, Brown University
Paula Braveman, University of San Francisco
Cheryl Clark, Brigham and Women's Hospital, Harvard University
Gilbert Gee, University of California, Los Angeles
Scarlett Gomez, University of California, San Francisco
Brad Greenwood, George Mason University
Kekoa Taparra, Stanford University
Sean Valles, Michigan State University
David Williams, Harvard T.H. Chan School of Public Health
Tissues
Scope
Collection and sampling of benign breast biopsy, colorectal adenomas, other precursor lesions, cancer tissues
Leadership
Mustapha Abubakar, M.D., Ph.D. (lead)
Resource Sharing Principles for Research
The principles of the Connect for Cancer Prevention Study data and biospecimen sharing policy will support extensive and appropriate use of the resource, consistent with NIH policy. Safeguards for privacy and confidentiality will be in place to protect participants’ data and biospecimens. Any researchers wishing to use the resources from the cohort will need to complete an application. The process will vary for biospecimens and depend on the sensitivity of the requested data.
To improve data traceability and reproducibility of analyses and results according to FAIR (Findable, Accessible, Interoperable, Reusable) data principles, Connect data access will be granted through a cloud-hosted Connect for Cancer Prevention Data Platform. The Data Platform will facilitate access to raw and derived data, metadata, data dictionaries, and annotated code to all platform users.
All projects approved for data and sample use will be noted on the study website, including project summaries and study team descriptions.
For more information, contact Mia Gaudet.