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.

NCT02160795 | Withdrawn

• 2 other identifiers: 99991409314-C-N093
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pediatric Leukemia; Pediatric Brain Neoplasms; Other Pediatric Cancers

Keywords

Periconceptional; Folic Acid; Leukemia; Childhood Cancer

Outcome Measures

Primary Outcomes (1)

• Pediatric cancer

  outcomes include pediatric leukemia, pediatric brain tumors and other pediatric cancers

  1994-2015

Eligibility Criteria

• Age: 17 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Leukemia; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Martha Linet, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2014
• First Posted: June 11, 2014
• Study Start: March 27, 2014
• Primary Completion: February 23, 2018
• Study Completion: October 9, 2018
• Last Updated: December 16, 2019

Record last verified: 2018-10-09