Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care (OPTEC)
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|ClinicalTrials.gov Identifier: NCT03460483|
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2018
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Adenocarcinoma Endometrial Carcinoma Lynch Syndrome Relatives||Other: Genetic Counseling Other: Genetic Testing Other: Laboratory Biomarker Analysis Procedure: Mutation Carrier Screening||Not Applicable|
I. 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.
V. 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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment|
|Actual Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2021|
Experimental: Comprehensive LS genetic testing
Testing for inherited forms of cancer and tumor sequencing
Other: Genetic Counseling
Undergo genetic counseling
Other: Genetic Testing
Undergo genetic testing
Other: Laboratory Biomarker Analysis
Procedure: Mutation Carrier Screening
Undergo tumor screening via next-generation sequencing
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460483
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Paul Goodfellow||Ohio State University Comprehensive Cancer Center|