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Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers


N/A
15 Years
45 Years
Open (Enrolling)
Both
In Utero Exposure

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Trial Information

Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers


Background: Emerging epidemiological evidence suggests that early-life exposures in
conjunction with genetic makeup and variability may be important in the etiology of many
common adult cancers. Prospectively collected information on adolescent and early adulthood
exposures is lacking and current evidence often relies on adult recall of the past with a
limited array of exposure variables.

Long Term Objective:

1. To investigate the feasibility of assessing exposures that may be linked to early life
exposures and to later diseases. Exposures include diet, physical activity,
UV-exposure, DNA methylation status, body size and reproductive factors. This
feasibility work will inform additional research in an existing large Chinese-U.SC.D C
collaborative project conducted in 1993- 1995, Community Intervention Program( ClP)( n
= 247,OOO).

Short Term Objectives:

2. To determine the feasibility of collecting and assess in the quality of data on
current, diet, nutritional status, physical activity, physical strength, UV exposure,
DNA methylation status and other environmental exposures as early life determinants of
adult cancer in adolescent 15 - 17 years of age and early adulthood in their mothers.

3. To assess differences in methylation status of DNA between those exposed to
periconceptional folic acid supplementation and those unexposed.

4. To compare dietary and physical activity self-reporting instruments against objective
measures of dietary intake and physical activity, respectively.

Eligibility: Pairs of mothers and their children aged 15-17 years from the ClP, who
completed an associated pilot study in Laoting (Task1), Hebei province in the North, and
Taicang, Jiangsu province in the South, and who agree to participate in the study. An
additional subsample of 100 children who completed an accompanying study (Task1), who agree
to participate in a sub-study will be eligible.

Design: This pilot study will include 100 pairs of children and their mothers recruited from
2 provinces. A total of 50 children, 25 children (aged 15 years) from a middle school (grade
8) and 25 children (aged 16-17 years) from a high school (grades 9 -10) will be identified
in each province. To the extent possible, approximately equal numbers of children of 15, 16
and 17 years of age will be recruited, stratified by gender and in utero exposure to folic
acid. An additional sub-sample of 100 children that completed an accompanying study (Task1)
will be enrolled for only saliva collection and completion of a food frequency
questionnaire.

Inclusion Criteria


- NCLUSION CRITERIA:

Pairs of mothers and their children 15 - 17 years of age who completed Task1 and who agree
to participate in the study( Task2 ).

EXCLUSION CRITERIA:

1. Maternal pill usage only after conception and those who may have stopped taking folic
acid pills before the second trimester.

2. Pairs of mothers and children not living together or where the mother is not the
primary guardian (e.g., mother died or never lived with the child). Children in
boarding schools will not be included.

3. Participants taking sulfa drugs (sulfonamides) as these drugs may interfere with
para-aminobenzoic acid (PABA), which will be used as a marker for 24-hour urine
collection.

4. History of allergy to sunscreen, which may indicate possible allergy to PABA. Due to
its UVB absorbing properties, PABA has been used as a component in sunscreen
preparations, especially in the past.

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Changes in DNA Methylation related to in utero or pregnancy folate exposure.

Principal Investigator

Nancy A. Potischman, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999912038

NCT ID:

NCT01517139

Start Date:

December 2011

Completion Date:

Related Keywords:

  • In Utero Exposure
  • Diet and Nutrition
  • Pregnancy Folate
  • In Utero Exposure
  • DNA Methylation
  • Physical Activity

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