Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

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

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

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

Phlebotomy - Blood sampling for GP88 at MM

standard of care tissue biopsy if clinically indicated.

SOC Tissue biopsy

Katherine Tkaczuk, MD

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.

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.

Measure the level of GP88 in the blood of healthy women who are having mammography screening for breast cancer. If study doctor refers subject for breast biopsy the investigator will collect the information from the biopsy.

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

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.

A&G Pharmaceutical

University of Maryland, Baltimore

NYC Chinese immigrants provided with narrative breast health education

Health education program utilizing narrative messages to promote breast cancer screening in Chinese immigrant women will be delivered in a group format in the community

Narrative breast health education

Lina Jandorf

The long-term goal of this research is to increase breast cancer screening rates in NYC Chinese immigrants. The researchers plan to accomplish this objective by developing and testing a culturally- and linguistically-adapted Witness Project program for Chinese immigrants. To inform the intervention development, the study team will identify barriers and facilitators to breast cancer screening in Chinese immigrants through individual qualitative interviews.

A total of 156 participants will be recruited during the entire study.

In Aim 1 which started in July 2021, 60 women were recruited for in-depth interviews to assess their breast cancer knowledge, perceived barriers and benefits/risks to completing mammography, perceived susceptibility to breast cancer, fatalism, screening intention, acculturation, language preference, and health literacy.

In Aim 2, 96 women will be recruited to participate in the pilot testing of the intervention. Recruitment will take place at community sites that serve Chinese immigrants in New York City. Enrollment for Aim 2 is anticipated to start in March of 2022.

Increasing Breast Cancer Screening in Chinese Immigrants

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Self-report completion of screening mammogram (Yes/No)

Question: How likely are you to undergo a screening mammogram in the next 6 months? (Very likely, Somewhat likely, Not sure, Somewhat not likely, Not at all likely)

Pre- and post-program survey to access feasibility and acceptability of adapted narrative education program. Full scale from 5 - 25, with a higher score indicating greater acceptability.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer	NCT02700776	Healthy Volunte...	Phlebotomy - Bl... SOC Tissue biop...	40 Years - 64 Years	University of Maryland, Baltimore
Increasing Breast Cancer Screening in Chinese Immigrants	NCT05089292	Screening Mammo...	Narrative breas...	40 Years -	Icahn School of Medicine at Mount Sinai
Increasing Breast Cancer Screening in Chinese Immigrants	NCT05089292	Screening Mammo...	Narrative breas...	40 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for screening mammogram