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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00341536 |
This pilot study will examine the potential for health, diet and lifestyle research in Delhi, Kerala, and Kolkota, India. It will: 1) evaluate the adequacy of the existing infrastructure for a large-scale epidemiologic investigation and follow-up; 2) obtain a characterization of the Indian diet; 3) determine study end-points; 4) evaluate the feasibility of collecting and analyzing biologic samples within India; and 5) evaluate the ability of centers to recruit subjects and collect data.
Indian men and women between 35 and 70 years of age who have resided in the study area (Delhi, Kerala, or Kolkota) for at least 1 year may be eligible for this study. Participants will undergo the following tests and procedures:
Part A: Diet and Lifestyle (2 visits)
Part B: Understanding Diet (6 visits)
Part C: Medical Follow-up Patterns (1 visit)
Condition |
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Chronic Diseases |
Study Type: | Observational |
Official Title: | A Feasibility Study for a Prospective Cohort in Delhi, India |
Estimated Enrollment: | 4044 |
Study Start Date: | June 2004 |
AIM: To conduct a pilot study in Delhi to assess the feasibility of establishing a prospective cohort.
Chronic diseases such as cancer, heart diseases, and diabetes, are now important public health issues in India. They share common risk factors.
Emphasis is being placed on understanding the etiology of these diseases. Over the last decade, India has developed an infrastructure conducive to state-of-the-art epidemiologic research studies. Several high-quality population- and hospital-based cancer registries are located throughout the country and also in Delhi. Now, there is a critical mass of epidemiologists, nutritionists, clinicians and statisticians who are committed to studying the etiology of chronic disease.
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Once a subject is identified, their eligibility for study participation will be determined based on the following:
Age between 35-70 years.
Use or would consider using certain medical centers/hospitals in the catchment area.
Resided in study area a minimum period of one year.
Must speak Hindi, Punjabi or English.
Female subjects cannot be pregnant.
EXCLUSION CRITERIA:
Children will be excluded from the study.
We will exclude persons with any physical ailments preventing them from study participation, and with recent chronic or other serious diseases or conditions that have made them alter their diet. This is likely to include cancer as well as cardiovascular disease or diabetes and also some infectious conditions.
Participants will be terminated from the study if they move outside of the study area.
Contact: Rashmi Sinha, Ph.D. | (301) 496-6426 | sinhar@epndce.nci.nih.gov |
India | |
Initiative for Cardiovascular Health Research in the Developing Countries | Recruiting |
New Delhi, India | |
Sub-Investigator: Prof. K. Srinath Reddy | |
Regional Cancer Centre | Recruiting |
Trivandum, India |
Study ID Numbers: | 999904219, 04-C-N219 |
Study First Received: | June 19, 2006 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00341536 History of Changes |
Health Authority: | United States: Federal Government |
Diet Pilot Cohort Environmental Chronic Disease |
Chronic Disease |
Disease Attributes Pathologic Processes Chronic Disease |