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Feasibility of Identifying a Chinese Study Population and Eligible Pediatric Cancer Cases, and Linking the Two Groups to Assess the Role of Periconceptional Folic Acid Supplements in Risk of Pediatric Cancer.

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ClinicalTrials.gov Identifier: NCT02160795
Recruitment Status : Withdrawn
First Posted : June 11, 2014
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

- Pregnant women are encouraged to take the vitamin folate. It helps prevent some birth defects. Children of mothers who take it also have less risk of some cancers. Between 1993 and 1995, some women in China took the vitamin daily before and during early pregnancy. Another group did not. This study will follow up on children born to both sets of women. (The children were born between 1994 and 1996.) Researchers will use these data to study the link between folate and cancer in infants and children.

Objective:

- To see if folate may reduce childhood cancer if women take it every day before and during early pregnancy.

Eligibility:

- Mothers who took part in a Chinese folic acid study between 1993 and 1995 and their offspring.

Design:

  • Mothers of children in the study will sign a consent form. The form lets the researchers review the child s medical history. They may also review data about their cancer diagnosis. The children will also sign a form.

Condition or disease
Pediatric Leukemia Pediatric Brain Neoplasms Other Pediatric Cancers

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Feasibility of Identifying the Chinese Community Intervention Program (CIP) Population and Eligible Incident Pediatric Cancer Cases, and Linking the Cases to the Population to Assess the Role of Periconceptional Folic Acid Supplements in Risk of Pediatric Cancer (Pilot #N3)
Study Start Date : March 27, 2014
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : October 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Folic acid




Primary Outcome Measures :
  1. Pediatric cancer [ Time Frame: 1994-2015 ]
    outcomes include pediatric leukemia, pediatric brain tumors and other pediatric cancers



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Eligibility and inclusion criteria are as follows for each specific aim:

Specific Aim #1. Families with a child born 1994-96 in the 21 CFCS counties and whose family members (mother, offspring, and child) match the identifying characteristics listed in Table 2.

Specific Aim #2. Children born during 1994-96 in the 21 CFCS counties who were diagnosed with incident pediatric cancers during 1994 to the present

Specific Aim #3. Children born during 1994-96 in the 21 counties and members of the CFCS population who were determined to have died during the 2000-2001 follow-up. Those eligible for this specific aim among children not known to have died based on the 2000-2001 follow-up will include children born during 1994-1996 in the 21 counties who are found to have died after 2000-2001 based on search of death certificates at the county- and provincial-level CDCs. Efforts will be undertaken to determine if children who died after 2000-2001 and are potentially eligible (born 1994-1996 in one of the 21 CFCS counties) were definitely or probably offspring members of the CFCS through review of death certificates and interview of mothers of the deceased children. For these offspring, review and abstracting of medical records for hospitalizations, or, if not available, interviews with primary care doctors of the children will be undertaken to determine if the individual definitely, probably, possibly or did not have a diagnosis of childhood cancer.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160795


Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Martha Linet, M.D. National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02160795    
Other Study ID Numbers: 999914093
14-C-N093
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: October 9, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Periconceptional
Folic Acid
Leukemia
Childhood Cancer
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases