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

NCT ID: NCT02700776

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 417 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-02-27

Brief Summary

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.

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COHORT I-BIRADS 1 or 2,

Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0 and 6-12.

Phlebotomy - Blood sampling for GP88 at MM

Intervention Type: OTHER

Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.

COHORT II -BIRADS 3

Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0, 3-6, and 6-12.

Phlebotomy - Blood sampling for GP88 at MM

Intervention Type: OTHER

Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.

COHORT III-BIRADS 4-6

SOC Tissue Biopsy. Occurs at months 0, 3-6, and 6-12.

Phlebotomy - Blood sampling for GP88 at MM

Intervention Type: OTHER

Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.

SOC Tissue biopsy

Intervention Type: PROCEDURE

standard of care tissue biopsy if clinically indicated.

Interventions

Phlebotomy - Blood sampling for GP88 at MM

Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.

Intervention Type: OTHER

SOC Tissue biopsy

standard of care tissue biopsy if clinically indicated.

Intervention Type: PROCEDURE

Other Intervention Names

GP88

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

A&G Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Tkaczuk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland Greenebaum Cancer Center

Locations

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, United States

Baltimore Washington Medical Center

Glen Burnie, Maryland, United States

Countries

United States

Other Identifiers

HP-00058144 1380GCC

Identifier Type: -

Identifier Source: org_study_id