Endometrial Cancer Clinical Trial
Official title:
Correlation Between Somatic Mismatch Repair Instability and Germline Mismatch Repair Instability, in Low Socioeconomic Background Population Diagnosed With Endometrial Endometrioid Adenocarcinoma
NCT number | NCT04516083 |
Other study ID # | 1272883 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 21, 2019 |
Est. completion date | June 30, 2021 |
The objective of the study is the provide proof of high correlation between somatic and
germline mismatch repair instability. This correlation is specifically researched in an area
where patients have less access to cancer education and genetic testing for various reasons
such as lack of insurance and general accessibility.
The study concentrates on early diagnosis of Lynch syndrome. Lynch syndrome is usually
diagnosed from a blood test resulting in a mutation of one of the mismatch repair genes.
Those are MLH1, MSH2, MSH 6, PMS2. A mutation in one of these genes creates a mismatch repair
instability,hence higher incidence of cancers in specific organ groups. Amongst these organs
are the Uterus, Ovaries, Upper genitourinary system, Pancreas and GI system.
The most common endometrial carcinoma which is found in Lynch syndrome is of endometrioid
histology. Most patients with known germline mismatch repair instability, have the same
somatic mutation. Our study is looking into correlating somatic mutation to germline
mutation.
By doing so, patients diagnosed with somatic mismatch repair instability will be also
diagnosed with lynch syndrome without germline genetic testing.
Screening programs will be utilized earlier and preventive procedures offered.
Due to less access to educational programs, genetic counseling and testing in underserved
areas, patients are sometimes lost to follow up. Our study seeks to prove high correlation
between somatic and germline mutations and by doing so, patient will be diagnosed with Lynch
syndrome straight after endometrial cancer staging. As a result, increased compliance will be
expected and patients will be offered the recommended preventative surgeries and screening
protocols.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Underserved areas. Diagnosis of endometrial endometrioid carcinoma. Low socioeconomic status. Positive mismatch repair staining. All races. All ages. All cancer grades. All cancer stages . Exclusion Criteria: Diagnosis of type 2 endometrial carcinoma. Cancer diagnosis other than Endometrial. No mismatch repair genes mutation. High socioeconomic status. |
Country | Name | City | State |
---|---|---|---|
United States | Jersey city medical center | Jersey City | New Jersey |
Lead Sponsor | Collaborator |
---|---|
RWJ Barnabas Health at Jersey City Medical Center |
United States,
Chu MM, Liu SS, Tam KF, Ip PP, Cheung AN, Ngan HY. The Significance of Mismatch Repair Deficiency in Young Patients With Endometrial Cancer. Int J Gynecol Pathol. 2015 Sep;34(5):403-10. doi: 10.1097/PGP.0000000000000174. — View Citation
Kahn RM, Gordhandas S, Maddy BP, Baltich Nelson B, Askin G, Christos PJ, Caputo TA, Chapman-Davis E, Holcomb K, Frey MK. Universal endometrial cancer tumor typing: How much has immunohistochemistry, microsatellite instability, and MLH1 methylation improved the diagnosis of Lynch syndrome across the population? Cancer. 2019 Sep 15;125(18):3172-3183. doi: 10.1002/cncr.32203. Epub 2019 May 31. Review. — View Citation
Modica I, Soslow RA, Black D, Tornos C, Kauff N, Shia J. Utility of immunohistochemistry in predicting microsatellite instability in endometrial carcinoma. Am J Surg Pathol. 2007 May;31(5):744-51. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who have a somatic mutation at the same time as a germline mutation | Resected tissue during endometrial staging will be immunohistochemically stained for MMR mutation. Patient blood test will be checked for MMR gene mutation Linear regression curve will be constructed to evaluate the correlation between somatic and germline mutation. |
Through study completion, an average of 18 months |
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