American Cancer Society Cohorts:

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American Cancer Society Cohorts

• 100-Year History
• 1950-2050

45 and Up Meeting September 20, 2007 Jeanne
Calle, PhD
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Analytic Epidemiology
Mission Statement

• To conduct and publish high-quality
  epidemiologic research to advance our
  understanding of cancer etiology and thereby
  contribute to the prevention of cancer and death
  from cancer.

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History of ACS Follow-up Studies

• Partnership
• ACS researchers and volunteers
• Began in early 1950s
• Results
• link between smoking and lung cancer
• impact of obesity on cancer deaths
• link between aspirin and colon cancer
• impact of TSP2.5

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ACS Historical Cohorts

• Hammond-Horn Study
• 1952 to 1955
• 188,000 U.S. men, 9 states
• 22,000 ACS volunteers
• Cancer Prevention Study (CPS) I
• 1959 to 1972
• 1,000,000 U.S. men and women, 25 states
• 68,000 ACS volunteers

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SMOKING AND DEATH RATES-REPORT ON FORTY-FOUR
MONTHS OF FOLLOW-UP OF 187,783 MEN I. TOTAL
MORTALITY II. DEATH RATES BY CAUSE E. Cuyler
Hammond, Sc.D. and Daniel Horn, Ph.D.
N Engl J Med 1661159-1308, 1958
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1954- Cuyler Hammond, Donald Horn, and Charles
Cameron (Medical Director of ACS) at AMA
conference in 1954
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ACS Contemporary Cohorts

• CPS II Mortality Cohort
• 1982 to present - ongoing
• 1,200,000 U.S. men and women, 50 states
• 77,000 ACS volunteers
• CPS II Nutrition Cohort
• 1992 to present - ongoing
• 184,000 U.S. men and women, 21 states
• 7,000 ACS volunteers

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CPS-II Cohorts
Repeat questionnaires Nutrition Cohort
1997 1999 2001 2003
1982 Baseline Questionnaire
1992 Baseline Questionnaire
1998
2002
Mortality Cohort
Nutrition Cohort
Blood
1.2 million
184,000
40,000
Buccal Cell
70,000
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• Goal
• To collect and archive blood samples from
  40,000 CPS-II participants for future research

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LifeLink Methods

• 300 hospitals nationwide served as blood
  collection sites
• Blood was sent overnight to a central
  biorepository
• Sub-aliquot
• Store in Liquid Nitrogen

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Buccal (Cheek) Cell Collection By Mail

• Supplement the blood specimens with DNA
  specimens from additional CPS-II Nutrition Cohort
  members

Source Feigelson H et. al. 2001 CEBP101005-8.
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Buccal Cell Collection Kit
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NEW ACS COHORTPlanning for CPS-3
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CPS-3 Rationale and Objectives
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OBJECTIVES

• Enroll a diverse cohort of 500,000 men and women
• 30-65 years of age
• Never been diagnosed with cancer
• Willing to make a long-term commitment to the
  study (by completing questionnaires every few
  years)
• Recruitment goals
• At least 25 minority (racial/ethnic)
  participation
• Geographic diversity

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WHY WE NEED CPS-3?

• CPS-II is aging (median age77 years)
• Changes in environment and lifestyles lead to new
  research directives
• Ex Assessing how the rise in obesity impacts
  cancer risk
• New scientific technologies also lead to new
  research directives

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WHY IS CPS-3 IMPORTANT?

• Most new large, observational studies are
  overseas.
• Blood specimens on 500,000 individuals will be an
  entirely unique resource in the US.
• Brings CPS studies into the 21st century and
  allows us to be well-positioned to answer new and
  important questions in the future.

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Enrollment Venue

• Main enrollment venue -- Relay For Life
• Partnership with ACS volunteers
• Efficient for large-scale enrollment
• Committed, diverse population
• 2006-2011

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Relay For Life Sites in 2006
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Advantages of Relay For Life

• Partnership with ACS volunteer infrastructure
• Very successful in recruiting past ACS cohorts
• Large groups of people in one place for extended
  period of time
• We will target 1000 events that have 1000
• participants
• Committed population (including minorities)
• Critical for maintaining high follow-up rates
• Geographic diversity

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Limitations of Relay For Life

• Added logistics-outdoors, weather, temporary
  facilities
• Non-fasting specimens only
• No centrifuge onsite
• Difficulty in collecting some types of samples
  (ex. urine)
• Can consider collection of some specimens after
  enrollment

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2006 (Implementation) Pilots

• 6 pilots in Spring 2006 (Texas, metro
  Atlanta, California)
• 1,376 enrolled
• Goals
• Assess efficiency and effectiveness of enrollment
  protocol (through RFL and volunteers)
• Assess effectiveness of partnership with Quest
  Diagnostics for blood collection, transport, and
  processing

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Study Participation

• Initial enrollment at RFL
• Complete a brief survey and sign informed consent
  and HIPAA
• Provide a waist measurement
• Provide a small blood sample
• Within 3 months after enrollment at RFL, mailed
  baseline survey
• To collect complete, detailed environmental and
  lifestyle information
• Follow-up into the future
• Repeat surveys every two years to update exposure
  and outcome information

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CPS-3 ENROLLMENT PROCESS
1

• Enrollment should take 30 minutes

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2006 Pilot Results

• Successful logistics for enrollment
• Successful collection, transport, storage of
  bloods
• Successful recruitment of minorities
• Cant just build it and they will come
• - need visibility and promotion
• Our minority group is men

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CPS-3 Pilot Work in 2007

• Recruitment (Phase II) Pilots
• California 13 events
• South Atlantic 16 events
• High Plains 19 events
• Implementation (Phase I) Pilots
• 4 or 5 events per division
• New England, Florida, Great West, Eastern
• Pilot test Spanish-translated materials

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Timeline for CPS-3 Enrollment
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Geographic Diversity
Puerto Rico
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Selection of CPS-3 States

• Where is most of the population?
• Selected 25 states account for 81 of US
  population
• Where are high quality state cancer registries?
• TN and VA not included due to quality of state
  cancer registries
• Where are Quest Diagnostics central labs?

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Study Oversight

• Emory University IRB
• Certificate of Confidentiality (NCI) pending
• External Scientific Peer Review
• Biospecimen Advisory Group
• NHO CPS-3 Senior Strategy Team
• Divisional Implementation Team

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For More Information

• Website (www.cancer.org/cps3)
• Toll-free number (1-888-604-5888)
• Email cps3_at_cancer.org

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What to Do While Waiting for Your Cohort to Mature

• Cross sectional studies
• Predictors of screening
• Predictors of weight gain
• Any genotype/phenotype association
• Methodologic Studies
• Validate linkage with National Death Index
• Validate linkage with state registries
• DNA yield and quality from buccal cells
• Nutrition Cohort baseline paper
• GWS in paired blood and buccal samples
• Transforming cryopreserved lymphocytes

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Contributions of American Cancer Societys Cancer
Prevention Studies to Obesity Research
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• How is the relationship between BMI mortality
  different in smokers and sick people?

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Relative Risk of Death from All Causes according
to Race, CPS-II Women 1982-2004
White
Relative Risk
Black
BMI
Source Calle EE. unpublished
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Relative Risk of Death from All Causes according
to Race, CPS-II Men 1982-2004
White
Black
Relative Risk
BMI
Source Calle EE. (unpublished)
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Summary of Cancer Mortality by Body Mass Index -
Men
1.3
Prostate (gt 35)
1.5
Non-Hodgkins lymphoma (gt 35)
1.5
1.7
All Cancers (gt 40)
1.7
All other cancers (gt 30)
1.7
Kidney (gt 35)
1.8
Multiple myeloma (gt 35)
1.8
Gall bladder (gt 30)
Cause of Death (Highest BMI Category)
1.9
Colon Rectum (gt 35)
1.9
Esophageal (gt 30)
2.6
Stomach (gt 35)
4.5
Pancreas (gt 35)
Liver (gt 35)
Relative Risk and 95 CI
Based on never-smoking men. Source Calle EE
et.al. NEJM 20033481625-38.
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Summary of Cancer Mortality by Body Mass Index -
Women
1.4
Colon Rectum (gt 40)
1.5
1.5
Multiple myeloma (gt 35)
1.7
Ovarian (gt 35)
1.9
Liver (gt 35)
2.0
All Cancers (gt 40)
Non-Hodgkins lymphoma (gt 35)
2.1
2.1
Breast (gt 40)
2.5
Gall bladder (gt 30)
Cause of Death (Highest BMI Category)
2.6
All other cancers (gt 40)
2.8
Esophageal (gt 30)
3.2
Pancreas (gt 40)
4.8
Cervical (gt 35)
6.3
Kidney (gt 40)
Uterus (gt 40)
Relative Risk and 95 CI
Based on never-smoking women. Source Calle
EE et.al. NEJM 20033481625-38.
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BMI and Breast Cancer Incidence, CPS-II
Nutrition Cohort, 1992-97
BMI at baseline in 1992
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P for trend lt.0001
From age 18 to 1992
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New Developments

• With Nutrition Cohort DNA, part of a consortium
  to investigate genetic predictors of obesity
• Obesity as a predictor of survival from different
  cancers (Nutrition Cohort
• CPS-3 -- sadly, enrollees BMI looks just like
  US population

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THANK YOU!
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Confidentiality and Data Access

• CPS-3 survey data are kept confidential by
• Unique study ID numbers
• Limiting access to any identifying information to
  authorized personnel only
• Keeping study documents in a locked, limited
  access research storage room
• Having all staff sign confidentiality forms
  (including vendors and enrollment volunteers)
• Certificate of Confidentiality, HIPAA regulations
• Cohort membership will not be disclosed in other
  ACS constituent databases
• Individual results will not be shared with
  participants or their family, physicians,
  employers, insurance companies or other third
  parties