# Proteomic, Genomic, and Longitudinal Pathways to Ovarian Cancer Biomarker Discovery

> **NIH NIH U01** · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $82,995

## Abstract

Project Summary
This administrative supplement seeks support for administration of the Uterine Lavage Study by the
principal investigator and a research coordinator. Since the study has become a multi-year study due
to COVID and other reasons, and administrative support was only available for the first year, support
is needed to maintain administration of the study in a cohesive and organized fashion.
The Uterine Lavage Study (ULS) aims to elucidate the relative contributions to detection of ovarian
cancer from tumor DNA in uterine lavage (UL) and in Pap smears, and protein biomarkers from blood,
uterine lavage, and Pap smear fluid, using newly available detection and sample collection
technologies. Six sites will enroll patients into this study into two cohorts. In the first cohort, the study
will enroll 200 patients scheduled for surgery for suspected ovarian cancer. Enrolling patients prior to
surgical diagnosis ensures the study will be PRoBE compliant. Up to two blood draws will be obtained
preoperatively or up to 31 days prior to surgery, and a uterine lavage and Pap smear will be obtained
immediately prior to surgery. The expectation is that ~50 of these patients will have pathologically
confirmed ovarian cancer. In a second cohort, 50 patients with an inherited BRCA1 or BRCA2
deleterious mutation without suspected ovarian cancers who are scheduled for risk-reducing salpingo-
oophorectomy (RRSO) will be enrolled. Based on published reports, it is expected that that ~5 patients
will have microscopic or low volume ovarian cancer identified on SEE-FIM pathologic examination. In
each cohort, the patients with a pathologic invasive epithelial ovarian cancer diagnosis will be defined
as Cases and patients without any ovarian cancer, primary peritoneal cancer (PPC), or other cancer
identified due to the surgery, will be defined as Controls. Other cancer groups are: (i) PPC, (ii) non-
invasive serous tubal intraepithelial carcinoma (STIC) lesions, (iii) non-epithelial ovarian cancers, and
(iv) non-ovarian cancers. Analytic sites will determine TP53 mutation status and 25-gene panel
mutation status, targeted methylation, global methylation, and protein abundances in the uterine
lavage, Pap smear biospecimens, and in blood for cases and controls. Statistical analyses will identify
biomarkers which distinguish cases from controls with a high specificity, and determine the
complementarity of biomarkers from each biospecimen. Such analyses will identify a classifier based
on a panel of biomarkers that is likely to serve as high probability candidates for the early detection of
ovarian cancer.

## Key facts

- **NIH application ID:** 10426776
- **Project number:** 3U01CA152990-10S2
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Michael Birrer
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $82,995
- **Award type:** 3
- **Project period:** 2021-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10426776

## Citation

> US National Institutes of Health, RePORTER application 10426776, Proteomic, Genomic, and Longitudinal Pathways to Ovarian Cancer Biomarker Discovery (3U01CA152990-10S2). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10426776. Licensed CC0.

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