Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in High-Risk Endometrial Cancers

Study Overview
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Brief Summary
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This study is to find out how well liquid biopsies work as a non-invasive alternative to other methods of finding cancer cells (such as a tissue biopsy) in patients with high-risk endometrial cancer. A liquid biopsy is a blood test that may be able to find cancer cells. Collecting and storing samples of blood and tissue from patients with endometrial cancer to study in the laboratory may help doctors learn how the cells in the blood may change during treatment for uterine cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. Compare TP53, FBXW7, and other mutated gene variant allele frequencies (VAF) in serial circulating cell free deoxyribonucleic acid (ccfDNA) samples obtained from patients with high-risk endometrial cancer subtypes during the primary treatment course, which may include pretreatment, post-surgical removal, post adjuvant treatment, and at time of recurrence. II. Compare the findings from the liquid biopsy mutational analysis to next generation sequencing from the primary tumor. EXPLORATORY OBJECTIVES: I. To estimate the presence of malignant cells in the vagina before and after minimally invasive hysterectomy among patients with high-risk endometrial cancer. II. Characterize the immune profile and single cell ribonucleic acid (RNA) sequencing (scRNAseq) profile of high-risk endometrial cancer subtypes. III. Estimate time to progression (TTP), and investigate potential correlations between mutated gene variant allele frequency (VAF) ccfDNA samples and progression. IV. Compare the efficacy of experimental ccfDNA assays to approved ccfDNA assay using the same samples. OUTLINE: Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy.

Official Title
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A Pilot Investigation to Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in High-Risk Endometrial Cancers

Conditions
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Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Mucinous Adenocarcinoma, Endometrial Serous Adenocarcinoma, Malignant Uterine Neoplasm, Uterine Corpus Carcinosarcoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Liquid Biopsy
* Other: Pap Smear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age 18 years and older Diagnosis of high-risk uterine cancer, including carcinosarcoma, clear cell, mucinous, serous, and dedifferentiated tumors Candidate for primary surgical treatment Willing and able to provide informed consent Exclusion Criteria: Patients who have received prior treatment including surgery, chemotherapy or radiation therapy for endometrial cancer. Note: patients with a history of other cancers may be enrolled after discussion with the principal investigator (PI) if it is determined that they are at low risk for recurrence or metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (biospecimen collection, Pap smear)<br>Patients undergo collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy, after hysterectomy but before starting any chemotherapy, and at the end of last chemotherapy cycle. Patients also undergo collection of tissue samples during hysterectomy. Patients may also undergo Pap smears before and after hysterectomy. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and tissue samples<br>* Other names: Biological Sample Collection;Procedure: Liquid Biopsy<br>* Undergo liquid biopsy<br>* Other names: Plasma Biopsy;Other: Pap Smear<br>* Undergo Pap smear<br>* Other names: Vaginal Smears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of circulating cell free deoxyribonucleic acid (ccfDNA) mutations | The proportion of ccfDNA mutations determined by liquid biopsy will be calculated along with 95% confidence intervals, and comparison between treatment time points will be performed. | through study completion, an average of 1 year |