Endometrial AdenocarcinomaOPTECNCT03460483
Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care
A study testing Genetic Counseling, Genetic Testing and Laboratory Biomarker Analysis in people with Endometrial Adenocarcinoma and Endometrial Carcinoma, run by Ohio State University Comprehensive Cancer Center at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Carcinoma, Lynch Syndrome
- What is being tested?
- Genetic Counseling, Genetic Testing and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Mar 2018to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult women who had a hysterectomy or diagnostic biopsy proving endometrial adenocarcinoma (any stage) between 10/1/2017 and 4/30/2020, and received care at one of the participating hospitals
- Adult relatives of the EC patients found to have LS
Who cannot join
- Individuals must be able to speak and read English; non-English speaking individuals will be excluded
- Individuals must be able to consent for themselves; those who are unable to consent for themselves for any reason will be excluded
- Prisoners will be specifically excluded from participation in the study
- Women who have uterine sarcomas are excluded
- Pregnant women are not eligible for the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304
Aultman Health Foundation
Canton, Ohio, 44710
University of Cincinnati
Cincinnati, Ohio, 45219
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45245
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Ohio Health
Columbus, Ohio, 43214
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
About this study
Official title: Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.
II. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.
III. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.
IV. Provide local access to genetic counseling for patients with harmful germline mutations.
- Identify molecular signatures that may be associated with favorable response to specific treatments (including chemotherapeutic agents, non-surgical options, and novel clinical trials [in particular, patients with mismatch repair (MMR)-deficient or POLE-mutant tumors]).
VI. Determine if recurrence likelihood can be predicted from molecular signature.
VII. Identify EC patients with select molecular signatures for recruitment to long-term follow-up, cancer prevention, and treatment studies.
OUTLINE:
Patients with endometrial cancer undergo clinical testing for inherited cancer mutations using blood DNA and via next-generation sequencing of tumor samples. 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.
- Being tested
- Genetic Counseling, Genetic Testing, Laboratory Biomarker Analysis, Mutation Carrier Screening
- Medical subject headings
- Endometrial Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic CounselingOther
Undergo genetic counseling
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
Laboratory Biomarker AnalysisOther
Correlative studies
Mutation Carrier ScreeningProcedure or surgery
Undergo tumor screening via next-generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive LS genetic testing | Experimental | Testing for inherited forms of cancer and tumor sequencing Receives: Other: Genetic Counseling; Other: Genetic Testing; Other: Laboratory Biomarker Analysis; Procedure: Mutation Carrier Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of endometrial cancer patients with Lynch syndrome
Measured by molecular profiling of tumor deoxyribonucleic acid (DNA) via next-generation sequencing.
Measured: Up to 3 years
Incidence of tumors with microsatellite instability and/or somatic POLE mutations
Measured by molecular profiling of tumor DNA via next-generation sequencing.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start30 Mar 2018
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Goodfellow, Ohio State University Comprehensive Cancer Center
- Investigators
- Paul Goodfellow, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460483
- Sponsor's protocol ID
- OSU-17149
- Other IDs
- NCI-2018-00218
- Acronym
- OPTEC
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2018
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment
- ClinicalTrials.gov ID
- NCT03460483
- Acronym / sponsor ID
- OPTEC / OSU-17149
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.
II. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.
III. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.
IV. Provide local access to genetic counseling for patients with harmful germline mutations.
- Identify molecular signatures that may be associated with favorable response to specific treatments (including chemotherapeutic agents, non-surgical options, and novel clinical trials [in particular, patients with mismatch repair (MMR)-deficient or POLE-mutant tumors]).
VI. Determine if recurrence likelihood can be predicted from molecular signature.
VII. Identify EC patients with select molecular signatures for recruitment to long-term follow-up, cancer prevention, and treatment studies.
OUTLINE:
Patients with endometrial cancer undergo clinical testing for inherited cancer mutations using blood DNA and via next-generation sequencing of tumor samples. 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive LS genetic testing | Experimental | Other: Genetic Counseling, Other: Genetic Testing, Other: Laboratory Biomarker Analysis, Procedure: Mutation Carrier ScreeningTesting for inherited forms of cancer and tumor sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult women who had a hysterectomy or diagnostic biopsy proving endometrial adenocarcinoma (any stage) between 10/1/2017 and 4/30/2020, and received care at one of the participating hospitals
- Adult relatives of the EC patients found to have LS
Key exclusion criteria (5 listed)
- Individuals must be able to speak and read English; non-English speaking individuals will be excluded
- Individuals must be able to consent for themselves; those who are unable to consent for themselves for any reason will be excluded
- Prisoners will be specifically excluded from participation in the study
- Women who have uterine sarcomas are excluded
- Pregnant women are not eligible for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic CounselingUndergo genetic counseling | Other | Comprehensive LS genetic testing |
| Genetic TestingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Comprehensive LS genetic testing |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Comprehensive LS genetic testing |
| Mutation Carrier ScreeningUndergo tumor screening via next-generation sequencing | Procedure or surgery | Comprehensive LS genetic testing |
Primary outcome
Incidence of endometrial cancer patients with Lynch syndrome
Time frame: Up to 3 years
Measured by molecular profiling of tumor deoxyribonucleic acid (DNA) via next-generation sequencing.
Incidence of tumors with microsatellite instability and/or somatic POLE mutations
Time frame: Up to 3 years
Measured by molecular profiling of tumor DNA via next-generation sequencing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Goodfellow principal investigator
Ohio State University Comprehensive Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Counseling, Genetic Testing and Laboratory Biomarker Analysis in people with Endometrial Adenocarcinoma and Endometrial Carcinoma, run by Ohio State University Comprehensive Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of endometrial cancer patients with Lynch syndrome (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.