Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cervical Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/9/2018 |
| Start Date: | March 30, 2018 |
| End Date: | March 1, 2021 |
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.
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.
PRIMARY OBJECTIVES:
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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