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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-18

Study Completion Date

2028-06-30

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 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.

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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 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 endometrial cancer.

II. Characterize the immune profile and single cell ribonucleic acid (RNA) sequencing (scRNAseq) profile of 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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (biospecimen collection, Pap smear)

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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood and tissue samples

Liquid Biopsy

Intervention Type PROCEDURE

Undergo liquid biopsy

Pap Smear

Intervention Type OTHER

Undergo Pap smear

Interventions

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Biospecimen Collection

Undergo collection of blood and tissue samples

Intervention Type PROCEDURE

Liquid Biopsy

Undergo liquid biopsy

Intervention Type PROCEDURE

Pap Smear

Undergo Pap smear

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Plasma Biopsy Cervical Smear Preparation Cervical Smear Procedure Pap Smear Procedure Pap Test Papanicolaou Smear Procedure Papanicolaou Test Vaginal Smears

Eligibility Criteria

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Inclusion Criteria

* Women age 18 years and older
* Histologic diagnosis of endometrial cancer
* Candidate for primary surgical treatment or has recently had prior primary surgery
* Willing and able to provide informed consent

Exclusion Criteria

Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Patients with prior primary surgery will be allowed to enroll in this trial if the patient has not received any chemotherapy or radiation at the time of enrollment. Note: patients with a history of other cancers may be enrolled after discussion with the PI if it is determined that they are at low risk for recurrence or metastasis.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No