DNA Sequencing for Endometrial Cancer

(OPTEC Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-English speakers, Unable to consent, Prisoners, Uterine sarcomas, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

1001 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch repair deficiency in patients with endometrial cancer, mutations in the genes responsible for Lynch syndrome (inherited forms of endometrial cancers) and other DNA changes that could help guide treatment strategies. Universal tumor DNA sequencing may help doctors better understand how to personalize care, increase length of life, and increase quality of life in patients with endometrial cancer and their relatives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Universal Endometrial Cancer DNA Sequencing for endometrial cancer?

Research shows that analyzing circulating tumor DNA (ctDNA) can help detect and monitor endometrial cancer recurrence and progression, suggesting that DNA sequencing could be a useful tool for early detection and personalized treatment planning. This approach has been effective in identifying cancer activity and predicting treatment responses in other aggressive forms of endometrial cancer, like uterine serous carcinoma. ^{1 2 3 4 5}

Is DNA sequencing for endometrial cancer safe for humans?

The research does not provide specific safety data for DNA sequencing in humans, but it focuses on the diagnostic potential and technical performance of sequencing methods for detecting endometrial cancer. ^{2 6 7 8 9}

How does the Universal Endometrial Cancer DNA Sequencing treatment differ from other treatments for endometrial cancer?

This treatment is unique because it uses DNA sequencing to identify specific genetic changes in endometrial cancer, allowing for a more personalized approach to treatment. Unlike traditional methods, it can detect microsatellite instability and POLE mutations, which helps in classifying the cancer more accurately and potentially guiding targeted therapies. ^{1 2 10 11 12}

Research Team

Paul Goodfellow

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adult women diagnosed with endometrial adenocarcinoma who had a hysterectomy or biopsy between certain dates and were treated at participating hospitals. It's also for their relatives found to have Lynch Syndrome. Excluded are non-English speakers, those unable to consent, prisoners, pregnant women, and women with uterine sarcomas.

Inclusion Criteria

I had a hysterectomy or biopsy showing endometrial cancer between 10/1/2017 and 4/30/2020.

I am an adult relative of someone with Lynch syndrome.

Exclusion Criteria

I can make my own medical decisions.

Individuals must be able to speak and read English; non-English speaking individuals will be excluded

Prisoners will be specifically excluded from participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing

Patients undergo clinical testing for inherited cancer mutations using blood DNA and next-generation sequencing of tumor samples

Up to 3 years

Genetic Counseling

Patients testing positive for Lynch syndrome or other cancer susceptibilities will undergo genetic counseling and testing and counseling will be offered to their family members

Follow-up

Participants are monitored for safety and effectiveness after genetic testing and counseling

Up to 3 years

Treatment Details

Interventions

• Universal Endometrial Cancer DNA Sequencing

Trial Overview The study is testing universal DNA sequencing on tumors from endometrial cancer patients to detect Lynch Syndrome and other genetic changes that could inform personalized treatment plans aimed at improving lifespan and quality of life.

Participant Groups

Group I: Comprehensive LS genetic testing Experimental Treatment 4 Interventions

Testing for inherited forms of cancer and tumor sequencing

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Mutational profile in circulating tumor DNA in a patient affected by low-risk endometrial cancer: predictable tool of relapse? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Adoption of Universal Testing in Endometrial Cancers for Microsatellite Instability Using Next-Generation Sequencing. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of Circulating Tumor DNA for Detection and Monitoring of Endometrial Cancer Recurrence and Progression. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Genetic analysis of uterine aspirates improves the diagnostic value and captures the intra-tumor heterogeneity of endometrial cancers. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Monitoring Treatment Response, Early Recurrence, and Survival in Uterine Serous Carcinoma and Carcinosarcoma Patients Using Personalized Circulating Tumor DNA Biomarkers. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnostic Potential of Endometrial Cancer DNA from Pipelle, Pap-Brush, and Swab Sampling. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Determination of the Cancer Genome Atlas (TCGA) Endometrial Cancer Molecular Subtypes Using the Variant Interpretation and Clinical Decision Support Software MH Guide. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Detection of endometrial precancer by a targeted gynecologic cancer liquid biopsy. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Cancer susceptibility gene mutations in type I and II endometrial cancer. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a droplet digital PCR assay for detecting POLE mutations and molecular classification of endometrial cancer. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

B7-H4 Further Stratifies Patients With Endometrial Cancer Exhibiting a Nonspecific Molecular Profile. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Traditional Approaches to Molecular Genetic Analysis. [2017]