1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
Stopped early
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is find out if a protein level in the blood (called PC Cell Derived Growth Factor or glycoprotein 88 \[GP88\]), combined with standard mammography screening, can help detect breast cancer better than mammography screening alone. Earlier research has shown that a certain glycoprotein 88 (GP88) is higher in women with breast cancer. In this study, investigators will measure the level of GP88 in the blood of healthy women who are having mammography screening for breast cancer. The investigator plans to correlate the results of the mammogram with the GP-88 level.
Key facts
- Study ID
- NCT02700776
- Run by
- University of Maryland, Baltimore
- People needed
- 417
- Starts
- 2014-04-01
- Expected to finish
- 2017-02-27
- Last updated by the study team
- 2019-11-07
Who can join
Age: 40 and older, up to 64. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female greater than or equal to 40 years.
- Presenting to UM Breast Center and BWMC for breast imaging: screening or diagnostic mammogram, breast ultrasound (US), breast MRI, stereotactic core needle biopsy, ultrasound core needle biopsy, MRI guided breast biopsy.
- Patients with a recent screening diagnosis of breast cancer < = 3months.
- Patients presenting with mammogram findings with BIRADS of 0-6 < =3 months.
- Able to understand and the willingness to sign a written informed consent document.
You may not qualify if…
- Patients with a personal history of stage 0-4 breast cancer >3months.
- Patients who have known severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation in the study, or personal history of other malignancies.
- Patients who are unfit or unable to comply with having breast imaging studies such as mammogram, ultrasound, and MRI or breast biopsy or with study procedures-blood draw.
- Patients with personal history of ovarian cancer or other cancers.
- Patients with a personal history of breast biopsy positive for atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS).
Where it is running
- University of Maryland, Greenebaum Cancer Center — Baltimore, Maryland, United States
- Baltimore Washington Medical Center — Glen Burnie, Maryland, United States
Full record on ClinicalTrials.gov
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