NCT00341263

Brief Summary

This study will examine levels of hormones, such as estrogen and testosterone, in maternal and umbilical cord blood to compare hormones between mothers who are having twins and mothers who are having one baby. It will investigate whether hormone levels in twin versus singleton pregnancies influence the babies' risk of developing breast, prostate, and testicular cancers later in life. Pregnant women 18 years of age and older who do not have preeclampsia, chronic hypertension, pre-pregnancy or gestational diabetes, thyroid disease, or other major pregnancy complications are eligible for this study. Participants will be recruited from the obstetrics and gynecology practice at the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire. Participants will have a blood sample drawn from their arm during their third trimester prenatal visit and again when they are admitted to the hospital for delivery. After the baby is born, a blood sample will be collected from the cut umbilical cord. Information about the pregnancy and delivery will be collected from the mother's medical chart, and information about the baby's size will be obtained from the baby's medical chart.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

February 21, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

June 19, 2006

Last Update Submit

February 20, 2020

Conditions

Normal Pregnancy

Keywords

TwinsClinical ResearchEndocrinologyBreast CancerBiochemical Epidemiology

Outcome Measures

Primary Outcomes (1)

  • Hormone concentrations

    Analysis of maternal and cord blood hormone concentrations inmonochorionic twin, dichorionic twin and singleton pregnancies of similar gestational age--especially with respect to cancer risk.

    Pregnancy

Study Arms (2)

Cases - twin pregnancies

Maternal and cord hormones in twins

Controls - singleton pregnancies

Maternal and cord hormones in singletons

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Mothers and children treated at Dartmouth Hitchcock Medical Center and Medical School.

You may not qualify if:

  • Eligible for study are pregnant women 18 years of age and older.
  • We will try to recruit women who do not have preeclampsia, chronic hypertension, pre-pregnancy or gestational diabetes, thyroid disease or other major pregnancy complications.
  • CASES:
  • Eligible women who are pregnant with twins.
  • CONTROLS (Singletons):
  • Three control groups will be recruited: two for the mother of twins (one at the third trimester, one at delivery), and one for the twins themselves at delivery.
  • A singleton pregnancy that meets the eligibility criteria and can be matched to the case pregnancy on gestational age (within 1 week), parity (nulliparous vs. parous) and maternal age (+/- 5 years) will be recruited for study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darmouth-Hitchcock Medical Center

Hanover, New Hampshire, 03756, United States

Location

Related Publications (3)

  • Andersson SW, Bengtsson C, Hallberg L, Lapidus L, Niklasson A, Wallgren A, Hulthen L. Cancer risk in Swedish women: the relation to size at birth. Br J Cancer. 2001 May 4;84(9):1193-8. doi: 10.1054/bjoc.2000.1738.

    PMID: 11336470BACKGROUND

  • Braun MM, Ahlbom A, Floderus B, Brinton LA, Hoover RN. Effect of twinship on incidence of cancer of the testis, breast, and other sites (Sweden). Cancer Causes Control. 1995 Nov;6(6):519-24. doi: 10.1007/BF00054160.

    PMID: 8580300BACKGROUND

  • Buell P. Changing incidence of breast cancer in Japanese-American women. J Natl Cancer Inst. 1973 Nov;51(5):1479-83. doi: 10.1093/jnci/51.5.1479. No abstract available.

    PMID: 4762931BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rebecca Troisi, D.Sc.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

November 21, 2003

Primary Completion

July 1, 2009

Study Completion

February 19, 2020

Last Updated

February 21, 2020

Record last verified: 2020-01

Locations

US(1)