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

  • days left to enroll
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 4 October 2022


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.



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.


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.


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.

Condition Uterine Corpus Carcinosarcoma, Uterine Cancer, Endometrial Mucinous Adenocarcinoma, uterine papillary serous carcinoma, Endometrial Serous Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Clear Cell Adenocarcinoma
Treatment biospecimen collection, Liquid Biopsy, Pap smear
Clinical Study IdentifierNCT05049538
SponsorM.D. Anderson Cancer Center
Last Modified on4 October 2022


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note