Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341536
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-06-19
Brief Title:
Feasibility Study for Prospective Diet and Lifestyle Cohorts in Delhi Kerala and Kolkota India
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Feasibility Study for Prospective Cohort in India
Status:
COMPLETED
Status Verified Date:
2013-11-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Questionnaires on medical history and treatment practices including questions on reproductive history
Brief medical examination
Body measurements including height weight forearm circumference thighs hips stomach skin thickness of the back and triceps back of the arms
Blood draw for research including studies of gene changes that affect the way the body uses nutrients
Collection of toenail clippings for research tests
Interview about 1 dietary habits and understanding of the relationship of diet to health 2 lifestyle work and family health and 3 moving history how often subject has moved in the past 5 years addresses of past homes and plans for future moves
Part B Understanding Diet 6 visits
Interview at each visit about food and drink consumed the day before the interview
2 blood draws
24-hour urine collection
Physical activity monitor The subject wears a small device placed on the belt or waist of the pants for a specified time to measure the amount of movement performed
Part C Medical Follow-up Patterns 1 visit
-Answer questions about medical history treatment practices and dietary habits
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
Questionnaires on medical history and treatment practices including questions on reproductive history
Brief medical examination
Body measurements including height weight forearm circumference thighs hips stomach skin thickness of the back and triceps back of the arms
Blood draw for research including studies of gene changes that affect the way the body uses nutrients
Collection of toenail clippings for research tests
Interview about 1 dietary habits and understanding of the relationship of diet to health 2 lifestyle work and family health and 3 moving history how often subject has moved in the past 5 years addresses of past homes and plans for future moves
Part B Understanding Diet 6 visits
Interview at each visit about food and drink consumed the day before the interview
2 blood draws
24-hour urine collection
Physical activity monitor The subject wears a small device placed on the belt or waist of the pants for a specified time to measure the amount of movement performed
Part C Medical Follow-up Patterns 1 visit
-Answer questions about medical history treatment practices and dietary habits
Detailed Description:
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 eg 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 eg 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 4000 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 1400 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
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 eg 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 eg 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 4000 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 1400 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-N219 | None | None | None |