Colorectal Neoplasms, Hereditary NonpolyposisNCT03291106
Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
An observational study of Colorectal Neoplasms, Hereditary Nonpolyposis and Endometrial Neoplasms, run by Lei Li at 1 site in China.
Trial summary
In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms
- What is being tested?
- immunohistochemical staining, tests of microsatellite instability and clinical criteria of Lynch syndromes
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Oct 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patiens with definite diagnosis of endometrial cancer, including type I and type II endometrial cancer.
Who may be able to join
- Survivals of endometrial cancer
Who cannot join
- Metatatic malignacies to uterine
- Leiomyosarcoma of uterus
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, China/Beiing, 100000
Lei L Li, MD, 13911988831 ext. +86, lileigh@163.com
About this study
Official title: Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch syndromes.
- Being tested
- immunohistochemical staining, tests of microsatellite instability, clinical criteria of Lynch syndromes, sequencing for mismatch repair genes
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical stainingDiagnostic test
immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2
tests of microsatellite instabilityDiagnostic test
microsatellite instability in tissues of endometrial cancer
clinical criteria of Lynch syndromesDiagnostic test
Amsterdam I or II criteria and Bethesda criteria
sequencing for mismatch repair genesDiagnostic test
next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Lynch syndromes in endometrial cancer
Proportions of patients carrying mismatch repair gene in endometrial cancer
Measured: 2 years
Secondary outcomes (3)
Reliability of immunohistochemical staining for screening Lynch syndromes
Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes
Measured: 2 years
Reliability of microsatellite instability for screening Lynch syndromes
Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes
Measured: 2 years
Reliability of clinical criteria for screening Lynch syndromes
Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms, Hereditary NonpolyposisStudies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291106
- Sponsor's protocol ID
- EC-LYNCH
- Status last verified
- Nov 2018
- First submitted
- 20 Sep 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Distributions of specific mutation genes of Lynch syndromes will be available for other researches by officially published papers.
Publications
Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Bi Y, Lang J. Comparison of screening strategies for Lynch syndrome in patients with newly diagnosed endometrial cancer: a prospective cohort study in China. Cancer Commun (Lond). 2019 Jul 15;39(1):42. doi: 10.1186/s40880-019-0388-2.
PubMed 31307542
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03291106
- Acronym / sponsor ID
- EC-LYNCH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 25 Sep 2017 (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.
In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2), (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from aforementioned screening methods, a molecular diagnosis with next-generation sequencing for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch syndromes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiens with definite diagnosis of endometrial cancer, including type I and type II endometrial cancer.
Key inclusion criteria (1 listed)
- Survivals of endometrial cancer
Key exclusion criteria (2 listed)
- Metatatic malignacies to uterine
- Leiomyosarcoma of uterus
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 stainingimmunohistochemical staining for MLH1, MSH2, MSH6 and PMS2 | Diagnostic test | – |
| tests of microsatellite instabilitymicrosatellite instability in tissues of endometrial cancer | Diagnostic test | – |
| clinical criteria of Lynch syndromesAmsterdam I or II criteria and Bethesda criteria | Diagnostic test | – |
| sequencing for mismatch repair genesnext-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) | Diagnostic test | – |
Primary outcome
Distribution of Lynch syndromes in endometrial cancer
Time frame: 2 years
Proportions of patients carrying mismatch repair gene in endometrial cancer
3 secondary outcomes
Reliability of immunohistochemical staining for screening Lynch syndromes
Time frame: 2 years
Reliability of microsatellite instability for screening Lynch syndromes
Time frame: 2 years
Reliability of clinical criteria for screening Lynch syndromes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 31307542Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Bi Y, Lang J. Comparison of screening strategies for Lynch syndrome in patients with newly diagnosed endometrial cancer: a prospective cohort study in China. Cancer Commun (Lond). 2019 Jul 15;39(1):42. doi: 10.1186/s40880-019-0388-2.
- Individual participant dataSharing planned: Yes. Distributions of specific mutation genes of Lynch syndromes will be available for other researches by officially published papers.
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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.
Lei Li, MD principal investigator
Peking Union Medical College Hospital
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 Colorectal Neoplasms, Hereditary Nonpolyposis and Endometrial Neoplasms, run by Lei Li at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, MD (13911988831 ext. +86, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Lynch syndromes in endometrial cancer (time frame: 2 years). 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 NCT03291106, which also lists 1 linked publication.
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 14 Nov 2018.