Lynch SyndromeNCT05257057

Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome

An observational study of Lynch Syndrome and Endometrial Cancer, run by WellSpan Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial… Read more about this study

Who is it for?: Ages 18 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Lynch Syndrome, Endometrial Cancer, Endometrial Hyperplasia
What is being tested?: Immunohistochemical staining
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 8 May 2019to 2 Jun 2023
Phase: Observational
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 to 99 years
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: Patients who underwent tissue sampling of any type and received a pathologic diagnosis of endometrial hyperplasia at WellSpan from 2014-2022.

Who may be able to join

Appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade

Who cannot join

Any specimen that is later associated with endometrial cancer in subsequent pathology exam

Trial locations and contacts

1 site in 1 country.

United States1 site

WellSpan
York, Pennsylvania, 17403

Other trials in United States

About this study

The purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of Lynch Syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. This will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the Lynch syndrome gene.

Read the detailed description

This is an observational cohort study. Tissue specimens obtained that have been labeled with the diagnosis of endometrial hyperplasia will be identified and their chart reviewed for demographic date of age, race, body mass index, and co-morbidities. The specimen will then be tested via immunohistochemistry for the mismatch repair proteins MLH1, PMS2, MSH2, or MSH 6. Their absence is indicative of Lynch Syndrome. Statistical analysis will then be performed to compare the incidence of Lynch syndrome in endometrial hyperplasia with Lynch Syndrome in endometrial cancer.

Conditions: Lynch Syndrome, Endometrial Cancer, Endometrial Hyperplasia, Mismatch Repair Deficiency, Microsatellite Instability
Being tested: Immunohistochemical staining
Keywords: Lynch Syndrome, endometrial hyperplasia, endometrial cancer, immunohistochemistry, mismatch repair
Medical subject headings: Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms, Endometrial Hyperplasia, Turcot syndrome, Microsatellite Instability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immunohistochemical stainingDiagnostic test
Immunohistochemistry will be performed on the endometrial tissue specimens

Study groups in NCT05257057
Study group	Role	What they receive
Endometrial hyperplasia		These are patients with a diagnosis of endometrial hyperplasia at WellSpan in the study time frame diagnosed via endometrial biopsy, dilation and curettage, or hysterectomy. Receives: Diagnostic Test: Immunohistochemical staining

What is being measured

The primary outcome is the main question the study is designed to answer.

Lynch Syndrome Screen Positive Rate
This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining
Measured: 2014-2022

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 20192 Jun 2023

First posted25 Feb 2022
Study start8 May 2019
Primary completion2 Jun 2023
Study completion2 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Lynch SyndromeStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05257057
Sponsor's protocol ID: 1403922-5
Status last verified: Apr 2024
First submitted: 16 Feb 2022
Last updated: 28 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hampel H, de la Chapelle A. The search for unaffected individuals with Lynch syndrome: do the ends justify the means? Cancer Prev Res (Phila). 2011 Jan;4(1):1-5. doi: 10.1158/1940-6207.CAPR-10-0345.
PubMed 21205737
Sehgal R, Sheahan K, O'Connell PR, Hanly AM, Martin ST, Winter DC. Lynch syndrome: an updated review. Genes (Basel). 2014 Jun 27;5(3):497-507. doi: 10.3390/genes5030497.
PubMed 24978665
Ryan NAJ, Blake D, Cabrera-Dandy M, Glaire MA, Evans DG, Crosbie EJ. The prevalence of Lynch syndrome in women with endometrial cancer: a systematic review protocol. Syst Rev. 2018 Aug 16;7(1):121. doi: 10.1186/s13643-018-0792-8.
PubMed 30115102
Wang Y, Wang Y, Li J, Cragun J, Hatch K, Chambers SK, Zheng W. Lynch syndrome related endometrial cancer: clinical significance beyond the endometrium. J Hematol Oncol. 2013 Mar 25;6:22. doi: 10.1186/1756-8722-6-22.
PubMed 23531335
ACOG Practice Bulletin No. 147: Lynch syndrome. Obstet Gynecol. 2014 Nov;124(5):1042-1054. doi: 10.1097/01.AOG.0000456325.50739.72. No abstract available.
PubMed 25437740
Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of "untreated" hyperplasia in 170 patients. Cancer. 1985 Jul 15;56(2):403-12. doi: 10.1002/1097-0142(19850715)56:23.0.co;2-x.
PubMed 4005805
de Leeuw WJ, Dierssen J, Vasen HF, Wijnen JT, Kenter GG, Meijers-Heijboer H, Brocker-Vriends A, Stormorken A, Moller P, Menko F, Cornelisse CJ, Morreau H. Prediction of a mismatch repair gene defect by microsatellite instability and immunohistochemical analysis in endometrial tumours from HNPCC patients. J Pathol. 2000 Nov;192(3):328-35. doi: 10.1002/1096-9896(2000)9999:99993.0.CO;2-2.
PubMed 11054716
Han SJ, Kim MK. Clinical significance of mismatch repair genes immunohistochemical expression of complex endometrial hyperplasia. Obstet Gynecol Sci. 2015 Mar;58(2):106-11. doi: 10.5468/ogs.2015.58.2.106. Epub 2015 Mar 16.
PubMed 25798423
Horn LC, Meinel A, Handzel R, Einenkel J. Histopathology of endometrial hyperplasia and endometrial carcinoma: an update. Ann Diagn Pathol. 2007 Aug;11(4):297-311. doi: 10.1016/j.anndiagpath.2007.05.002.
PubMed 17630117
Huang M, Djordjevic B, Yates MS, Urbauer D, Sun C, Burzawa J, Daniels M, Westin SN, Broaddus R, Lu K. Molecular pathogenesis of endometrial cancers in patients with Lynch syndrome. Cancer. 2013 Aug 15;119(16):3027-33. doi: 10.1002/cncr.28152. Epub 2013 Jun 12.
PubMed 23760948
Ichikawa Y, Tsunoda H, Takano K, Oki A, Yoshikawa H. Microsatellite instability and immunohistochemical analysis of MLH1 and MSH2 in normal endometrium, endometrial hyperplasia and endometrial cancer from a hereditary nonpolyposis colorectal cancer patient. Jpn J Clin Oncol. 2002 Mar;32(3):110-2. doi: 10.1093/jjco/hyf026.
PubMed 11956307
Ketabi Z, Gerdes AM, Mosgaard B, Ladelund S, Bernstein I. The results of gynecologic surveillance in families with hereditary nonpolyposis colorectal cancer. Gynecol Oncol. 2014 Jun;133(3):526-30. doi: 10.1016/j.ygyno.2014.03.012. Epub 2014 Mar 13.
PubMed 24631699
Manchanda R, Saridogan E, Abdelraheim A, Johnson M, Rosenthal AN, Benjamin E, Brunell C, Side L, Gessler S, Jacobs I, Menon U. Annual outpatient hysteroscopy and endometrial sampling (OHES) in HNPCC/Lynch syndrome (LS). Arch Gynecol Obstet. 2012 Dec;286(6):1555-62. doi: 10.1007/s00404-012-2492-2. Epub 2012 Aug 4.
PubMed 22865035
Sutter C, Dallenbach-Hellweg G, Schmidt D, Baehring J, Bielau S, von Knebel Doeberitz M, Gebert J. Molecular analysis of endometrial hyperplasia in HNPCC-suspicious patients may predict progression to endometrial carcinoma. Int J Gynecol Pathol. 2004 Jan;23(1):18-25. doi: 10.1097/01.pgp.0000101085.35393.4a.
PubMed 14668545
Vierkoetter KR, Kagami LA, Ahn HJ, Shimizu DM, Terada KY. Loss of Mismatch Repair Protein Expression in Unselected Endometrial Adenocarcinoma Precursor Lesions. Int J Gynecol Cancer. 2016 Feb;26(2):228-32. doi: 10.1097/IGC.0000000000000606.
PubMed 26807560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Not yet recruitingObservational study
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
Lynch Syndrome
Active, not recruiting
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma

All Lynch Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome
ClinicalTrials.gov ID: NCT05257057
Acronym / sponsor ID: 1403922-5
Conditions: Lynch Syndrome, Endometrial Cancer, Endometrial Hyperplasia, Mismatch Repair Deficiency, Microsatellite Instability
Keywords: Lynch Syndrome, endometrial hyperplasia, endometrial cancer, immunohistochemistry, mismatch repair
Study type: Observational
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: WellSpan HealthUniversity, hospital or other
Study start: 8 May 2019 (actual)
Primary completion: 2 Jun 2023 (actual)
Study completion: 2 Jun 2023 (actual)
First posted: 25 Feb 2022 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Endometrial hyperplasia	–	Diagnostic Test: Immunohistochemical stainingThese are patients with a diagnosis of endometrial hyperplasia at WellSpan in the study time frame diagnosed via endometrial biopsy, dilation and curettage, or hysterectomy.

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients who underwent tissue sampling of any type and received a pathologic diagnosis of endometrial hyperplasia at WellSpan from 2014-2022.

Key inclusion criteria (1 listed)

Appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade

Key exclusion criteria (1 listed)

Any specimen that is later associated with endometrial cancer in subsequent pathology exam

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
Immunohistochemical stainingImmunohistochemistry will be performed on the endometrial tissue specimens	Diagnostic test	Endometrial hyperplasia

Primary outcome

Lynch Syndrome Screen Positive Rate
Time frame: 2014-2022
This is the rate of subjects who screen positive for Lynch Syndrome based on immunohistochemical staining

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 28 Mar 2025.
Background: PubMed 21205737Hampel H, de la Chapelle A. The search for unaffected individuals with Lynch syndrome: do the ends justify the means? Cancer Prev Res (Phila). 2011 Jan;4(1):1-5. doi: 10.1158/1940-6207.CAPR-10-0345.
Background: PubMed 24978665Sehgal R, Sheahan K, O'Connell PR, Hanly AM, Martin ST, Winter DC. Lynch syndrome: an updated review. Genes (Basel). 2014 Jun 27;5(3):497-507. doi: 10.3390/genes5030497.
Background: PubMed 30115102Ryan NAJ, Blake D, Cabrera-Dandy M, Glaire MA, Evans DG, Crosbie EJ. The prevalence of Lynch syndrome in women with endometrial cancer: a systematic review protocol. Syst Rev. 2018 Aug 16;7(1):121. doi: 10.1186/s13643-018-0792-8.
Background: PubMed 23531335Wang Y, Wang Y, Li J, Cragun J, Hatch K, Chambers SK, Zheng W. Lynch syndrome related endometrial cancer: clinical significance beyond the endometrium. J Hematol Oncol. 2013 Mar 25;6:22. doi: 10.1186/1756-8722-6-22.
Background: PubMed 25437740ACOG Practice Bulletin No. 147: Lynch syndrome. Obstet Gynecol. 2014 Nov;124(5):1042-1054. doi: 10.1097/01.AOG.0000456325.50739.72. No abstract available.
Background: PubMed 4005805Kurman RJ, Kaminski PF, Norris HJ. The behavior of endometrial hyperplasia. A long-term study of "untreated" hyperplasia in 170 patients. Cancer. 1985 Jul 15;56(2):403-12. doi: 10.1002/1097-0142(19850715)56:23.0.co;2-x.
Background: PubMed 11054716de Leeuw WJ, Dierssen J, Vasen HF, Wijnen JT, Kenter GG, Meijers-Heijboer H, Brocker-Vriends A, Stormorken A, Moller P, Menko F, Cornelisse CJ, Morreau H. Prediction of a mismatch repair gene defect by microsatellite instability and immunohistochemical analysis in endometrial tumours from HNPCC patients. J Pathol. 2000 Nov;192(3):328-35. doi: 10.1002/1096-9896(2000)9999:99993.0.CO;2-2.
Background: PubMed 25798423Han SJ, Kim MK. Clinical significance of mismatch repair genes immunohistochemical expression of complex endometrial hyperplasia. Obstet Gynecol Sci. 2015 Mar;58(2):106-11. doi: 10.5468/ogs.2015.58.2.106. Epub 2015 Mar 16.
Background: PubMed 17630117Horn LC, Meinel A, Handzel R, Einenkel J. Histopathology of endometrial hyperplasia and endometrial carcinoma: an update. Ann Diagn Pathol. 2007 Aug;11(4):297-311. doi: 10.1016/j.anndiagpath.2007.05.002.
Background: PubMed 23760948Huang M, Djordjevic B, Yates MS, Urbauer D, Sun C, Burzawa J, Daniels M, Westin SN, Broaddus R, Lu K. Molecular pathogenesis of endometrial cancers in patients with Lynch syndrome. Cancer. 2013 Aug 15;119(16):3027-33. doi: 10.1002/cncr.28152. Epub 2013 Jun 12.
Background: PubMed 11956307Ichikawa Y, Tsunoda H, Takano K, Oki A, Yoshikawa H. Microsatellite instability and immunohistochemical analysis of MLH1 and MSH2 in normal endometrium, endometrial hyperplasia and endometrial cancer from a hereditary nonpolyposis colorectal cancer patient. Jpn J Clin Oncol. 2002 Mar;32(3):110-2. doi: 10.1093/jjco/hyf026.
Background: PubMed 24631699Ketabi Z, Gerdes AM, Mosgaard B, Ladelund S, Bernstein I. The results of gynecologic surveillance in families with hereditary nonpolyposis colorectal cancer. Gynecol Oncol. 2014 Jun;133(3):526-30. doi: 10.1016/j.ygyno.2014.03.012. Epub 2014 Mar 13.
Individual participant dataSharing planned: No

Related trials for Lynch Syndrome

RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Not yet recruitingObservational study
Protocol for Non-invasive Gynaecological Surveillance in Lynch Syndrome
Lynch Syndrome
Active, not recruiting
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma

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.

Eav Lim, DO principal investigator

WellSpan Health-York Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lynch Syndrome and Endometrial Cancer, run by WellSpan Health at 1 site 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 1 inclusion and 1 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Lynch Syndrome Screen Positive Rate (time frame: 2014-2022). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257057, which also lists 15 linked publications.

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 28 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.