DNA Sequencing for Endometrial Cancer

(OPTEC Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how DNA sequencing, specifically Universal Endometrial Cancer DNA Sequencing, can tailor treatments for individuals with endometrial cancer. The focus is on detecting DNA changes, such as those associated with Lynch syndrome, an inherited cancer risk. This approach aims to enhance the quality and length of life for patients and their relatives. Women who have had a hysterectomy or biopsy showing endometrial adenocarcinoma and received care at certain hospitals might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to personalized treatment options.

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 prior data suggests that this DNA sequencing is safe for endometrial cancer patients?

Research has shown that DNA sequencing for endometrial cancer is safe. Studies have not identified any safety issues with the DNA sequencing process itself. This method helps identify genetic changes, such as those linked to Lynch syndrome, an inherited condition that raises cancer risk.

No specific evidence indicates harmful effects from the DNA sequencing used to find these genetic changes. This type of testing is generally considered low-risk. The sequencing involves analyzing DNA from a sample, making it non-invasive except for the initial tissue collection.

While detailed safety data is not provided, the process resembles other genetic tests already used in medicine. This similarity suggests it is likely well-tolerated, with no major safety concerns reported in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about universal endometrial cancer DNA sequencing because it offers a personalized approach to diagnosing and treating cancer. Unlike traditional treatments that often rely on surgery or chemotherapy, this method involves comprehensive genetic testing to identify inherited cancer forms and perform detailed tumor sequencing. This can lead to more targeted and effective treatments by uncovering specific genetic mutations driving the cancer, potentially improving outcomes and reducing unnecessary treatments.

What evidence suggests that universal endometrial cancer DNA sequencing is effective for personalizing care in endometrial cancer?

Research has shown that testing the DNA of all endometrial cancer patients can help identify Lynch syndrome, a genetic condition that increases cancer risk. In this trial, participants will undergo comprehensive genetic testing for Lynch syndrome, which includes testing for inherited forms of cancer and tumor sequencing. Studies indicate that advanced DNA testing methods can detect changes in DNA, such as microsatellite instability (MSI), aiding in the detection of Lynch syndrome. This method not only identifies genetic changes but also helps doctors better understand the type of cancer. By knowing these genetic details, treatments can be customized to improve both the quality and length of life for patients. Testing tumor DNA offers a promising way to personalize care for endometrial cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul Goodfellow

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

I can make my own medical decisions.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ascopubs.org ascopubs.org/doi/abs/10.1200/PO.23.00033

Adoption of Universal Testing in Endometrial Cancers for ... Lynch syndrome screening by NGS in endometrial cancer allows concurrent molecular classification with one test.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10861015/

Adoption of Universal Testing in Endometrial Cancers for ... A next-generation sequencing (NGS) assay to detect microsatellite instability (MSI) as a screen for Lynch syndrome (LS) in endometrial cancer (EC).

3. lynchscreening.net lynchscreening.net/development/universal-screening-for-endometrial-cancer/

Screening for Endometrial Cancer - MLH1 methylation analysis was successful for 138/147 of the MSI cases. Among the 138 cases analyzed, 102 (74%) were methylated and 36 (26%) were unmethylated.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9024183/

Genomic landscape of advanced endometrial cancer ... These data indicated a 5-year survival rate of 60% for patients with TP53 mutations compared with up to 90% for those without mutations. In our study, the ...

5. trial.medpath.com trial.medpath.com/clinical-trial/d8af27072aa3f75e/nct03460483-ohio-endometrial-cancer-prevention-treatment

Universal Endometrial Cancer DNA Sequencing for Detection ... Universal tumor DNA sequencing may help doctors better understand how to personalize care, increase length of life, and increase quality of life in patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03460483

Universal Endometrial Cancer DNA Sequencing for ... This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch repair deficiency in patients with endometrial cancer, mutations in the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7565375/

Genetic Susceptibility to Endometrial Cancer: Risk Factors ... Endometrial cancer is a genetically heterogeneous disease with a prominent contribution of mismatch repair gene mutations that cause Lynch Syndrome.

8. withpower.com withpower.com/trial/phase-endometrial-neoplasms-2-2018-800fe

DNA Sequencing for Endometrial Cancer (OPTEC Trial) 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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3775889/

Genetic Testing Strategies in Newly Diagnosed Endometrial ... Testing all women newly diagnosed with endometrial cancer for Lynch syndrome may have clinical utility for the index case and her relatives.

10. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/10/2/108/46544/Clinical-Challenges-Associated-with-Universal

Clinical Challenges Associated with Universal Screening for ... Another significant risk factor for endometrial cancer is Lynch syndrome, an inherited cancer syndrome due to a germline mutation in one of the four DNA ...