Clinical trial · Observational
1380GCC: Prospective Study of GP-88 Blood Test in Healthy Women With Baseline Gail Model Risk Assessment Undergoing Screening for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phlebotomy - Blood sampling for GP88 at MM | Other | — | UNRESOLVED |
| SOC Tissue biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- COHORT I-BIRADS 1 or 2,
- description
- Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0 and 6-12.
- interventionNames
- Other: Phlebotomy - Blood sampling for GP88 at MM
- label
- COHORT II -BIRADS 3
- description
- Phlebotomy - Blood sampling for GP88 and MM. Occurs at months 0, 3-6, and 6-12.
- interventionNames
- Other: Phlebotomy - Blood sampling for GP88 at MM
- label
- COHORT III-BIRADS 4-6
- description
- SOC Tissue Biopsy. Occurs at months 0, 3-6, and 6-12.
- interventionNames
- Other: Phlebotomy - Blood sampling for GP88 at MM
- Procedure: SOC Tissue biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available