Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02700776
Status:
TERMINATED
Last Update Posted:
2019-11-07
First Post:
2016-03-01
Brief Title:
1380GCC Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
1380GCC Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
1380GCC
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None