Liquid Biopsy for Uterine Cancer

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a simple blood test, known as a liquid biopsy, can effectively detect cancer cells in women with endometrial cancer. The study aims to determine if this non-invasive method can predict cancer recurrence. Researchers will collect blood and tissue samples from participants before and after surgery and treatment to understand changes in cancer cells. Women with endometrial cancer who have not yet received chemotherapy or radiation are suitable candidates for this trial.

As a Phase 2 trial, this research measures the effectiveness of the liquid biopsy in an initial, smaller group, offering participants a chance to contribute to advancements in cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that liquid biopsies are safe for detecting cancer cells in patients with endometrial cancer?

Research has shown that liquid biopsies, blood tests used to detect cancer cells, are generally easy for patients to handle. These tests are non-invasive, meaning they don't involve surgery or cutting into the body, making them easier on patients compared to traditional methods like tissue biopsies.

Evidence suggests that liquid biopsies usually don't cause major side effects. Since they only involve drawing blood, much like a regular blood test, they are considered safe for most people. In cancer diagnosis and monitoring, liquid biopsies have provided important information without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using liquid biopsies and tumor molecular profiling to predict endometrial cancer recurrence. Unlike traditional methods that rely heavily on imaging and histopathology, liquid biopsies offer a less invasive way to gather essential genetic information from blood samples. This could lead to earlier and more accurate detection of cancer recurrence, potentially improving patient outcomes by allowing for timely interventions. Additionally, incorporating tumor molecular profiling helps personalize treatment plans, tailoring them to the unique genetic makeup of each patient's cancer.

What evidence suggests that liquid biopsies are effective for detecting cancer cells in endometrial cancer?

This trial includes an observational arm where participants will undergo biospecimen collection, including liquid biopsies and Pap smears. Studies have shown that liquid biopsies can effectively detect cancer cells in the body. They allow doctors to identify cancer without invasive procedures, such as tissue biopsies. Research indicates that liquid biopsies can find cancer cells in the blood, aiding in tracking cancer changes over time. This non-invasive method can be done quickly, making it easier for patients. Although researchers continue to study liquid biopsies, they show promise in helping doctors monitor endometrial cancer and adjust treatments as needed. ^{1 2 4 6 7}

Who Is on the Research Team?

Pamela T Soliman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Liquid Biopsy
• Pap Smear

How Is the Trial Designed?

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+

Citations

1. nature.com nature.com/articles/s41392-024-02021-w

Liquid biopsy in cancer: current status, challenges and ... Liquid biopsy has many advantages in the diagnosis and treatment of various types of cancer, including non-invasive, quickly and so on.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11130638/

Liquid biopsy for human cancer: cancer screening, monitoring ... Liquid biopsy is a novel, minimally invasive, real‐time detection tool for detecting information directly or indirectly released by tumors in human body fluids.

3. sciencedirect.com sciencedirect.com/science/article/pii/S295019542500013X

Enhancing detection and monitoring of circulating tumor cells Liquid biopsy offers a minimally invasive method for detecting and monitoring cancer, with key biomarkers including circulating tumor cells (CTCs), cell-free ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11010957/

The Role of Circulating Tumor Cells as a Liquid Biopsy for ... This review article explores the forefront of research and technology in the detection and isolation of circulating tumor cells (CTCs) for liquid biopsy ...

5. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-024-03026-7

Liquid biopsy techniques and lung cancer: diagnosis ... This review provides an overview of molecular biomarkers and assays utilized in liquid biopsies for lung cancer, encompassing CTCs, ctDNA, non-coding RNA ( ...

6. cap.org cap.org/member-resources/articles/the-liquid-biopsy

The 'Liquid' Biopsy A “liquid biopsy” does not replace a tissue-based diagnosis, but rather provides alternate sampling for (typically) molecular testing purposes.

7. bloodpac.org bloodpac.org/bloodpac-blog/circulating-tumor-cells

Understanding Circulating Tumor Cell-Based Liquid Biopsy In this article, we explore the identification, characterization, analysis, and clinical applications of circulating tumor cells as part of blood-based liquid ...