Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342654
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-15
First Post:
2006-06-19
Brief Title:
Nutrition Intervention Trials in Linxian Follow-up Study
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Nutritional Intervention Trials in Linxian China- Continued Follow-up
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10-15
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:
Two large nutritional intervention trials were conducted in Linxian China between 1985-1991 These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world Results from the trials showed that Beta-carotene Vitamin E selenium reduced total mortality total cancer mortality and stomach cancer incidence and mortality Multivitaminsminerals also showed reduction in premalignant lesions Preliminary follow-up data obtained for the time period after cessation of intervention in 1991 suggests that the observed benefit for total and cancer mortality is reduced but that the benefit for stomach cancer remains
The objectives of the follow-up study are 1 to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period 2 to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status asses the validity of dietary questionnaires and relate neurologic status to vitamin B12 plasma levels 3 to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses and 4 to perform nested case-control studies of selected genetic and environmental hypotheses
To accomplish the objectives of the follow-up study we will 1 determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry conduct a VitalCancer Status Interview Survey among all n-34000 trial participants or their surrogates identify collect and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period 2 conduct a Nutritional Survey on a subsample n-1000 of living trial participants that will include a a physical exam and brief medical history b a neurologic history c a cognitive function exam d a hairmouth skin exam e a neurological exam f a nutritional questionnaire and g collection of a blood sample for hematologicbiochemical analyses 3 conduct a Blood Collection Survey of all living trial participants n-23000 to obtain a a physical exam and brief medical history and b a single 10-ml blood sample for separation and preservation as WBCs both viable and nonviable RBCs and plasma for genetic eg xenobiotic polymorphisms and environmental eg plasma ascorbic acid hypothesis testing and 4 perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke These will be done using serum from the new cancer and stroke cases -2500 and controls -2500 previously identified from 1991-1996 as well as using new cancer and stroke cases and controls for the period 1996-2004 -9000
The followup for endpoints will continue monthly for an additional 5 years through the year 2003 The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999 The Nested Case-Control studies will be performed annually beginning in 2000 and the VitalCancer Interview Survey will be conducted in the Spring of 2001
The objectives of the follow-up study are 1 to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period 2 to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status asses the validity of dietary questionnaires and relate neurologic status to vitamin B12 plasma levels 3 to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses and 4 to perform nested case-control studies of selected genetic and environmental hypotheses
To accomplish the objectives of the follow-up study we will 1 determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry conduct a VitalCancer Status Interview Survey among all n-34000 trial participants or their surrogates identify collect and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period 2 conduct a Nutritional Survey on a subsample n-1000 of living trial participants that will include a a physical exam and brief medical history b a neurologic history c a cognitive function exam d a hairmouth skin exam e a neurological exam f a nutritional questionnaire and g collection of a blood sample for hematologicbiochemical analyses 3 conduct a Blood Collection Survey of all living trial participants n-23000 to obtain a a physical exam and brief medical history and b a single 10-ml blood sample for separation and preservation as WBCs both viable and nonviable RBCs and plasma for genetic eg xenobiotic polymorphisms and environmental eg plasma ascorbic acid hypothesis testing and 4 perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke These will be done using serum from the new cancer and stroke cases -2500 and controls -2500 previously identified from 1991-1996 as well as using new cancer and stroke cases and controls for the period 1996-2004 -9000
The followup for endpoints will continue monthly for an additional 5 years through the year 2003 The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999 The Nested Case-Control studies will be performed annually beginning in 2000 and the VitalCancer Interview Survey will be conducted in the Spring of 2001
Detailed Description:
Two large nutritional intervention trials were conducted in Linxian China between 1985-1991 These trials tested the effect of multiple vitamins and minerals in the prevention of esophageal cancer in a population with the highest known rate for this disease in the world Results from the trials showed that Beta-carotene Vitamin E selenium reduced total mortality total cancer mortality and stomach cancer incidence and mortality Multivitaminsminerals also showed reduction in premalignant lesions Preliminary follow-up data obtained for the time period after cessation of intervention in 1991 suggests that the observed benefit for total and cancer mortality is reduced but that the benefit for stomach cancer remains
The objectives of the follow-up study are 1 to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period 2 to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status asses the validity of dietary questionnaires and relate neurologic status to vitamin B12 plasma levels 3 to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses and 4 to perform nested case-control studies of selected genetic and environmental hypotheses
To accomplish the objectives of the follow-up study we will 1 determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry conduct a VitalCancer Status Interview Survey among all n approximately 34000 trial participants or their surrogates identify collect and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period 2 conduct a Nutritional Survey on a subsample n approximately 1000 of living trial participants that will include a a physical exam and brief medical history b a neurologic history c a cognitive function exam d a hairmouth skin exam e a neurological exam f a nutritional questionnaire and g collection of a blood sample for hematologic biochemical analyses 3 conduct a Blood Collection Survey of all living trial participants n approximately 23000 to obtain a a physical exam and brief medical history and b a single 10-ml blood sample for separation and preservation as WBCs both viable and nonviable RBCs and plasma for genetic eg xenobiotic polymorphisms and environmental eg plasma ascorbic acid hypothesis testing and 4 perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke These will be done using serum from the new cancer and stroke cases approximately 2500 and controls approximately 2500 previously identified from 1991-1996 as well as using new cancer and stroke cases and controls for the period 1996-2004 approximately 9000
The followup for endpoints will continue monthly for an additional 5 years through the year 2003 The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999 The Nested Case-Control studies will be performed annually beginning in 2000 and the VitalCancer Interview Survey will be conducted in the Spring of 2001
The objectives of the follow-up study are 1 to continue to determine cancer incidence and all causes of mortality in trial participants after intervention to permit examination of potential effects of the interventions on total and cause-specific mortality and cancer incidence in the post-intervention period 2 to conduct a cross-sectional nutritional survey in a subsample of living trial participants to evaluate their nutritional status asses the validity of dietary questionnaires and relate neurologic status to vitamin B12 plasma levels 3 to collect a blood sample from all living trial participants to permit further etiologic investigations of genetic and environmental hypotheses and 4 to perform nested case-control studies of selected genetic and environmental hypotheses
To accomplish the objectives of the follow-up study we will 1 determine updated vital status and cancer status data on all trial participants via monthly checks of village doctor records and quarterly checks of the Linxian Cancer Registry conduct a VitalCancer Status Interview Survey among all n approximately 34000 trial participants or their surrogates identify collect and store all available diagnostic materials for trial participants identified as having developed cancer or died with cancer during the follow-up period 2 conduct a Nutritional Survey on a subsample n approximately 1000 of living trial participants that will include a a physical exam and brief medical history b a neurologic history c a cognitive function exam d a hairmouth skin exam e a neurological exam f a nutritional questionnaire and g collection of a blood sample for hematologic biochemical analyses 3 conduct a Blood Collection Survey of all living trial participants n approximately 23000 to obtain a a physical exam and brief medical history and b a single 10-ml blood sample for separation and preservation as WBCs both viable and nonviable RBCs and plasma for genetic eg xenobiotic polymorphisms and environmental eg plasma ascorbic acid hypothesis testing and 4 perform Nested Case-Control Studies of selected genetic and environmental hypothesis related to the etiology and prevention of esophageal cancer and stroke These will be done using serum from the new cancer and stroke cases approximately 2500 and controls approximately 2500 previously identified from 1991-1996 as well as using new cancer and stroke cases and controls for the period 1996-2004 approximately 9000
The followup for endpoints will continue monthly for an additional 5 years through the year 2003 The Nutritional Survey and Blood Collection Survey will be conducted in the spring of 1999 The Nested Case-Control studies will be performed annually beginning in 2000 and the VitalCancer Interview Survey will be conducted in the Spring of 2001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| OH99-C-N031 | None | None | None |