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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2023
  • participants needed
    50
  • sponsor
    M.D. Anderson Cancer Center
Updated on 26 September 2021
carcinosarcoma

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 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.

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 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.

Details
Condition Uterine Cancer, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Uterine Corpus Carcinosarcoma, Endometrial Mucinous Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, uterine papillary serous carcinoma
Treatment biospecimen collection, Liquid Biopsy, Pap smear
Clinical Study IdentifierNCT05049538
SponsorM.D. Anderson Cancer Center
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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