Trial Information

A Feasibility Study for Prospective Cohort in India

Background

Cancer research in developing countries has not received adequate attention in spite of
having great potential to improve our understanding of genes and environmental exposures
such as diet in the etiology of cancer. Specifically, an Indian dietary cohort would
substantially expand the intake range and variety of different foods and lifestyles that
have not been adequately explored, e.g., spices, type of oils, lentils, vegetarianism (tied
to religion rather than healthy life-style'), and types of physical activities. Indians
also have distinct cancer incidence patterns. Establishing a cohort will allow us to study
multiple cancer outcomes as well as other disease end-points (e.g., cardiovascular disease
and diabetes), and it will avoid potential bias resulting from differential recall of past
diet by subjects, a critical concern in case-control studies that assess nutritional intake.
As measurement of various biological markers will be an integral component of this study, it
will be important to collect biological specimens prior to illness and treatment. This is
particularly important in India as cases may present with late stage disease.

Because a study of this magnitude and complexity has not been carried out in India, I have
proposed a pilot study to determine the feasibility of conducting a large cohort study in
India. The pilot study consists of three parts: 1) evaluation of logistical issues; 2)
characterization of the diet; and 3) evaluation of issues related to follow-up and end-point
ascertainment. In Part A of this pilot study there will be 4,000 subjects. This part of the
study will be evaluated for logistical issues, including questionnaire administration,
collection, storage, and analysis. Response rates for questionnaires, collection of
biospecimens and the centers' ability to carry out the proposed research will be evaluated
as well. Part B of the pilot study consists of a characterization of Indian diet to
determine within- and between-person variability in intake in a subset of 1,400 subjects; an
evaluation to determine whether Indians can estimate food quantities accurately; assess the
degree of measurement error in selected nutrients; and ascertain whether using multiple
forms of intake instruments in combination with biomarkers may categorize intake with less
error. In Part C of the pilot study, issues related to follow-up and end-point ascertainment
in 1200 subjects will be evaluated. In addition, an evaluation of the likelihood of cancers
and other chronic diseases remaining completely undiagnosed owning to lack of access to
health care; assess movement pattern and traceability of Indian populations; as well as an
evaluation of the cancer registry coverage and determine whether supplementary activities
are required.