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NCT05049538 Clinical Trial

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

Endometrial Serous Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05049538
Other study ID # PA19-0309
Secondary ID NCI-2021-08621
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2019
Est. completion date June 30, 2024

Study information
Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples
• Liquid Biopsy
Undergo liquid biopsy
Other:
• Pap Smear
Undergo Pap smear

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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