NCT05049538

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

A Pilot Investigation to Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancer

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

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

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and tissue samples
PROCEDURE	Liquid Biopsy	Undergo liquid biopsy
OTHER	Pap Smear	Undergo Pap smear

Timeline

• Start date: 2019-06-18
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2021-09-20
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States