Jump to: Authorized Access | Attribution | Authorized Requests

Study Description

  • To identify, confirm and code all malignancies appearing among participants of every generation of the Framingham Heart Study
  • To describe relationships between already identified FHS "risk factors" and the development of malignancies among participants
  • To describe interactions among risk factors, CVD, and cancer in the FHS population(s)

In 1948, researchers recruited men and women from the town of Framingham, Massachusetts, beginning the first round of extensive physical examinations and lifestyle interviews that would later be analyzed for common patterns related to CVD development.

Initially, the Framingham Heart Study enrolled 5,209 men and women from the Framingham area who were between the ages of 28 and 62 years. Beginning in 1971, the Framingham Heart Study enrolled 5,124 men and women, who were either offspring of the original cohort or spouses of those offspring. In 2002, 4,095 third generation participants (men and women) were enrolled.

During each clinic exam cycle, the participants undergo a detailed examination including physical examination, medical history, laboratory testing, and electrocardiogram. Over the years, other tests (that may not be performed at every exam cycle) have included pulmonary function, lifestyle, physical function, cognitive function questionnaires, and various noninvasive cardiovascular tests including echocardiograms. The content of each exam cycle differs for Original, Offspring and Generation 3 cohorts and can be found in the Exam Cycle Protocol Manuals.

Authorized Access
Publicly Available Data
Study Inclusion/Exclusion Criteria

Included are the codes for all FHS reviewed cases of primary cancers (malignant or in-situ). The codes have been verified by pathology reports or occasionally by other clinical records for all Framingham Heart Study participants in all cohorts who reported a tumor or cancer at an examination or on a health history survey.

Excluded are cases described in pathology reports as benign tumors or tumors of borderline malignancy, or cases described as metastases from other primary cancers. Also excluded are recurrences of basal cell and squamous cell skin cancers; the first occurrence of each of these series is the only one included for any individual person.

Study History

In the early 1970's, there was a full review of every page of every Original Cohort's FHS chart, looking for clues indicating that participants might have had cancer. Many of these clues led to confirmed diagnoses then; but many cases were left open. In the late 1980's, a formal review was conducted, including all suspect and all confirmed prior cases, plus all clues regarding possible cancers noted since the first review. This time, the Original Cohort, the Offspring Cohort and Third Generation were included. Pathology reports were obtained for almost all cases; and every cancer was coded using the ICD-O system. The FHS Cancer database has been updated periodically since the 1980's and is now being done continuously, as participants are seen in person, via Health Updates, and from medical records/reports. All three generations are included now.

The Generation 1 (or Original) cohort Exam 1 took place between 1948 and 1953. Biennial exams have continued to the present. Exam 29 took place between 2006 and 2007. Exam 30 began in 2008.

The Generation 2 (or Offspring) cohort Exam 1 took place between 1971 and 1975. This cohort on average has been examined every three to four years. However, there was an eight year gap between Exam 1 and Exam 2 and a seven year gap between Exam 7 and Exam 8. Exam 8 took place between 2005 and 2008.

The Generation 3 cohort Exam 1 took place between 2002 and 2005. Exam 2 began in 2008.

The New Offspring Spouse cohort Exam 1 took place between 2003 and 2005. Exam 2 began in 2008.

Selected Publications
Diseases/Traits Related to Study (MeSH terms)
Authorized Data Access Requests
Study Attribution
  • Principal Investigator
    • Bernard E. Kreger, MD, MPH. Boston University, Boston, MA, USA.
  • Institution
    • National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
  • Funding Source
    • Framingham Heart Study Contract. National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.