Clinical trial NCT05049538: Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancers
Official title: A Pilot Investigation to Determine the Utility of Liquid Biopsies and Tumor Molecular Profiling in Predicting Recurrence in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Clear Cell Adenocarcinoma
Endometrial Dedifferentiated Carcinoma
Endometrial Mucinous Adenocarcinoma
Endometrial Serous Adenocarcinoma
Malignant Uterine Neoplasm
Uterine Corpus Carcinosarcoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of uterine cancer

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of circulating cell free deoxyribonucleic acid (ccfDNA) mutations
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Pamela T Soliman
role: PRINCIPAL_INVESTIGATOR
References: