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CompletedNCT00276120Updated Jan 25, 2023

Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer

An observational study in Invasive Breast Cancer, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Ohio State University Comprehensive Cancer Center · Observational

Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
4,385
Ages
18 Years to 80 Years
Sex
Female
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Study summary

The purpose of this study is to identify novel genetic factors which distinguish breast cancer in younger women compared to older women. By identifying these novel genetic factors we believe more specific therapies can be developed and breast cancer may be prevented among women with an increased cancer risk. A woman does not have to live in St. Louis to participate.

Read the detailed description

Breast cancer takes its greatest toll on younger women, as it is the leading category of cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women diagnosed at a young age. This impact is most significant among African-American women who have the highest incidence and mortality rate among women less than 45 years of age. The goal of our program is to identify the genetic factors which distinguish breast cancer in younger women compared to older women.

Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited to participate. The age at diagnosis is used to determine eligibility, not a woman's current age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a consent form, submit a sample of blood, release their cancer related records, and answer some family history questions.

We will use a family based case control approach in our analysis. As such, if a woman's parents are living, they will be invited to participate as a "comparison" group. The parents are asked to: sign a consent form, submit a sample of blood, and release any cancer records.

A woman does not have to live in St. Louis to participate. All study related materials can be mailed directly to the young woman or her parents. There is no expense to the family. All materials are kept strictly confidential and participation is completely voluntary.

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Conditions studied

  • Invasive Breast Cancer

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Keywords

  • Breast
  • Cancer
  • Young
  • Women
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 4,385 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

women diagnosed with invasive breast cancer \< 40 years of age

Inclusion criteria

  • Women diagnosed with invasive breast cancer 40 years of age or younger. If their parents are living, the parents are also invited to participate, regardless of their history of cancer.

Exclusion criteria

Exclusion Criteria:

  • Women diagnosed with in-situ breast cancer.
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Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
4,385 participants (actual)
Biospecimen retention
Samples with dna
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Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43210, United States
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00276120
Lead sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
Barnes-Jewish Hospital
Responsible party
Amanda Toland (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted
Jan 12, 2006
Start date
Mar 2005
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jan 25, 2023

Study contacts

Amanda Toland, PhD
principal investigator · The Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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