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

Overseen By Pamela T Soliman, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Chemotherapy, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pamela T Soliman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Collection of blood samples for liquid biopsy during pre-treatment consultation before hysterectomy

1 week

1 visit (in-person)

Post-surgical

Collection of blood samples after hysterectomy but before starting any chemotherapy

1 week

1 visit (in-person)

Chemotherapy

Collection of blood samples at the end of the last chemotherapy cycle

Varies based on chemotherapy regimen

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Biospecimen Collection
• Liquid Biopsy
• Pap Smear

Participant Groups

Group I: Observational (biospecimen collection, Pap smear) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+