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

NCT05049538 | Recruiting

• 2 other identifiers: PA19-0309NCI-2021-08621
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Dedifferentiated Carcinoma; Endometrial Mucinous Adenocarcinoma; Endometrial Serous Adenocarcinoma; Malignant Uterine Neoplasm; Endometrial Clear Cell Adenocarcinoma; Uterine Corpus Carcinosarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational (biospecimen collection, Pap smear)

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.

Procedure: Biospecimen Collection; Procedure: Liquid Biopsy; Other: Pap Smear

Interventions

Liquid Biopsy PROCEDURE

Undergo liquid biopsy

Also known as: Plasma Biopsy

Observational (biospecimen collection, Pap smear)

Pap Smear OTHER

Undergo Pap smear

Also known as: Cervical Smear Preparation, Cervical Smear Procedure, Pap Smear Procedure, Pap Test, Papanicolaou Smear Procedure, Papanicolaou Test, Vaginal Smears

Observational (biospecimen collection, Pap smear)

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Also known as: Biological Sample Collection

Observational (biospecimen collection, Pap smear)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of uterine cancer

You may qualify if:

• 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

You may not qualify if:

• Patients who have received prior treatment including chemotherapy or radiation therapy for endometrial cancer. Prior hormonal therapy for the treatment of endometrial cancer is allowed. 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Liquid Biopsy; Papanicolaou Test; Vaginal Smears

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques; Surgical Procedures, Operative; Diagnostic Techniques, Obstetrical and Gynecological

Study Officials

• Pamela T Soliman

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela T Soliman, MD

CONTACT

713-745-2352; psoliman@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 20, 2021
• Study Start: June 18, 2019
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)