1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer (1380GCC)

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Phlebotomy - Blood sampling for GP88 at MM; Procedure: SOC Tissue biopsy

Detailed Description

Eligible healthy women >= 40 years old at average risk for developing breast cancer will be offered participation in the study at the time they present for routine screening mammogram (MM) at the University of Maryland Breast Screening Center and Baltimore Washington Medical Center; includes women who present to the center as a referral for further diagnostic workup of recent screening diagnosis of breast cancer <= to 3 months with mammographic findings on screening MM with BIRADS 0-6<= 3 months.

Informed consent will be reviewed with the study participant and She will be asked if She wishes to participate in this study. Once the volunteer agrees and signs the consent, her eligibility criteria will be reviewed by the study coordinator and if eligible the patient will be enrolled. Her MM, US or MRI results will be obtained and the study subject will be assigned to one of the 3 cohorts of patients.

COHORT I-BIRADS 1 or 2, COHORT II -BIRADS 3 COHORT III-BIRADS 4-6.

The first blood sample (20ml) for GP-88 will be drawn within 31 days of the initial signing of the informed consent. It is expected that majority of women attending the screening and diagnostic program at the UM Breast Center will be approached about this study. The investigator expects to screen 1400 and consent approximately 800 women in 12 months.

Once deemed eligible the study participant will have their first GP-88 blood sample drawn (20ml) within 31 days of signing the consent. The investigator will make every effort to draw the blood sample for GP-88 on the day of the visit to our breast center and will try not to ask study participants to come back to have the blood samples drawn unless the patient is willing to do it. However the study participant does have the option to have the GP-88 blood sample drawn within 31 days of her screening or diagnostic MM, US or breast MRI or biopsy if she wishes to participate but cannot do it on the day of her visit here. If the initial-first blood sample is never drawn the patient will be considered a screen failure, if subsequent blood samples will not be drawn or if the patient does not return for follow up screening or diagnostic MM or other testing as recommended by the radiologists, she will be replaced by another subject.

• Study Type: Observational
• Enrollment (Actual): 417

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Greenebaum Cancer Center
    • Glen Burnie, Maryland, United States, 21061
      • Baltimore Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COHORT I-BIRADS 1 or 2,; Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0 and 6-12.	Other: Phlebotomy - Blood sampling for GP88 at MM; Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.; Other Names: GP88
COHORT II -BIRADS 3; Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0, 3-6, and 6-12.	Other: Phlebotomy - Blood sampling for GP88 at MM; Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.; Other Names: GP88
COHORT III-BIRADS 4-6; SOC Tissue Biopsy. Occurs at months 0, 3-6, and 6-12.	Other: Phlebotomy - Blood sampling for GP88 at MM; Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.; Other Names: GP88; Procedure: SOC Tissue biopsy; standard of care tissue biopsy if clinically indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography	1. To prospectively determine the GP-88 blood levels in healthy female volunteers who are undergoing routine screening mammography at the UM Breast Center, Baltimore Washington Medical Center and other local breast imaging referral centers and in patients with biopsy-confirmed breast cancer.	12 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: A&G Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): February 27, 2017
• Study Completion (ACTUAL): February 27, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (ESTIMATE): March 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; screening mammogram; GP88
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HP-00058144 1380GCC