Colo-rectal CancerLYNXNCT06990633
Lynch Syndrome in Colorectal Cancer Surgery
An observational study of Colo-rectal Cancer and Hereditary Diseases, run by Izmir Ataturk Training and Research Hospital.
Trial summary
Study Design (Material and Methods) This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Hereditary Diseases, Lynch Syndrome
- What is being tested?
- diagnostic test
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) who undergo surgical resection for histologically confirmed colorectal adenocarcinoma at tertiary hospitals in Türkiye. Participants will include both elective and emergency surgical cases. All patients will have their tumor samples evaluated for MMR protein expression by immunohistochemistry. Patients with abnormal MMR expression will undergo further genetic testing. The population will represent a real-world surgical cohort, including both hereditary and sporadic colorectal cancer cases.
Who may be able to join
- Age 18 years or older
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Undergoing surgical resection at one of the participating general surgery departments
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue for MMR analysis
- Consent to participate in the study and undergo genetic testing if indicated
Who cannot join
- Age below 18 years
- Diagnosis other than colorectal adenocarcinoma
- Incomplete or unavailable postoperative pathology results
- Inadequate tissue samples for IHC analysis
- Patients who decline participation in the study at any point
- Patients who do not attend or refuse referral to genetic counseling after pathology results
About this study
Official title: LYNX STUDY: Lynch Syndrome in Colorectal Cancer Surgery - A Multicentre, Prospective Cohort Study
Study Design (Material and Methods)
This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments.
Read more
Over a 12-month period, patients undergoing surgery for histologically confirmed colorectal cancer at multiple tertiary hospitals across Türkiye will be enrolled. Postoperative pathological assessments will include immunohistochemical (IHC) analysis for mismatch repair (MMR) protein expression (MLH1, PMS2, MSH2, and MSH6).
In cases showing loss of MLH1 and PMS2 expression, BRAF mutation testing will be performed. If BRAF mutation is detected, MLH1 promoter methylation analysis will follow. A positive result in both tests will suggest a sporadic etiology, whereas the absence of both findings will lead to referral for germline genetic testing using next-generation sequencing (NGS) to investigate Lynch syndrome.
For patients with isolated MSH2 and/or MSH6 loss, direct referral to genetic testing will be carried out without BRAF or methylation testing.
Patients with intact MMR expression will be recorded as the MMR-proficient control group. Comparative analysis will be conducted between dMMR and MMR-proficient patients, including demographic characteristics (age, sex, family history of cancer), tumor staging, anatomical location, and presence of metastases.
The primary outcome is to determine the incidence of Lynch syndrome among surgically treated colorectal cancer patients in Türkiye and to identify clinical and pathological correlations.
Read the detailed description
Study Design (Material and Methods)
This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments.
Over a 12-month period, patients undergoing surgery for histologically confirmed colorectal cancer at multiple tertiary hospitals across Türkiye will be enrolled. Postoperative pathological assessments will include immunohistochemical (IHC) analysis for mismatch repair (MMR) protein expression (MLH1, PMS2, MSH2, and MSH6).
In cases showing loss of MLH1 and PMS2 expression, BRAF mutation testing will be performed. If BRAF mutation is detected, MLH1 promoter methylation analysis will follow. A positive result in both tests will suggest a sporadic etiology, whereas the absence of both findings will lead to referral for germline genetic testing using next-generation sequencing (NGS) to investigate Lynch syndrome.
For patients with isolated MSH2 and/or MSH6 loss, direct referral to genetic testing will be carried out without BRAF or methylation testing.
Patients with intact MMR expression will be recorded as the MMR-proficient control group. Comparative analysis will be conducted between dMMR and MMR-proficient patients, including demographic characteristics (age, sex, family history of cancer), tumor staging, anatomical location, and presence of metastases.
The primary outcome is to determine the incidence of Lynch syndrome among surgically treated colorectal cancer patients in Türkiye and to identify clinical and pathological correlations.
- Conditions
- Colo-rectal Cancer, Hereditary Diseases, Lynch Syndrome
- Being tested
- diagnostic test
- Keywords
- Lynch Syndrom, Colorectal Cancer
- Medical subject headings
- Colonic Neoplasms, Genetic Diseases, Inborn, Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic testDiagnostic test
Group 1: MMR-Proficient Group Label: MMR-Proficient
Description: Patients with normal expression of MMR proteins on IHC analysis. No indication for further genetic testing.
Type: Observational Group
Group 2: dMMR Group Label: dMMR
Description: Patients with loss of MMR protein expression (MLH1, PMS2, MSH2, or MSH6) on IHC. These patients will undergo further molecular or genetic analysis to evaluate for Lynch syndrome.
Type: Observational Group
| Study group | Role | What they receive |
|---|---|---|
| dmmr | dmmr Receives: Diagnostic Test: diagnostic test | |
| mmr expression normal | mmr expression normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Lynch Syndrome Among Surgically Treated Colorectal Cancer Patients
The primary outcome is to determine the incidence of Lynch syndrome in patients who undergo surgery for colorectal cancer. The diagnosis will be based on initial immunohistochemical (IHC) analysis of MMR protein expression (MLH1, PMS2, MSH2, MSH6), followed by molecular and germline testing (BRAF mutation, MLH1 promoter methylation, and next-generation sequencing) when indicated.
Measured: Within 12 months following surgical resection and pathological assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SAADET KOCA, Izmir Ataturk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990633
- Sponsor's protocol ID
- Hilal
- Acronym
- LYNX
- Status last verified
- Feb 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LYNX STUDY: Lynch Syndrome in Colorectal Cancer Surgery - A Multicentre, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06990633
- Acronym / sponsor ID
- LYNX / Hilal
- Conditions
- Colo-rectal Cancer, Hereditary Diseases, Lynch Syndrome
- Keywords
- Lynch Syndrom, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 May 2025 (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.
Study Design (Material and Methods)
This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments.
Over a 12-month period, patients undergoing surgery for histologically confirmed colorectal cancer at multiple tertiary hospitals across Türkiye will be enrolled. Postoperative pathological assessments will include immunohistochemical (IHC) analysis for mismatch repair (MMR) protein expression (MLH1, PMS2, MSH2, and MSH6).
In cases showing loss of MLH1 and PMS2 expression, BRAF mutation testing will be performed. If BRAF mutation is detected, MLH1 promoter methylation analysis will follow. A positive result in both tests will suggest a sporadic etiology, whereas the absence of both findings will lead to referral for germline genetic testing using next-generation sequencing (NGS) to investigate Lynch syndrome.
For patients with isolated MSH2 and/or MSH6 loss, direct referral to genetic testing will be carried out without BRAF or methylation testing.
Patients with intact MMR expression will be recorded as the MMR-proficient control group. Comparative analysis will be conducted between dMMR and MMR-proficient patients, including demographic characteristics (age, sex, family history of cancer), tumor staging, anatomical location, and presence of metastases.
The primary outcome is to determine the incidence of Lynch syndrome among surgically treated colorectal cancer patients in Türkiye and to identify clinical and pathological correlations.
Detailed description
Study Design (Material and Methods)
This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments.
Over a 12-month period, patients undergoing surgery for histologically confirmed colorectal cancer at multiple tertiary hospitals across Türkiye will be enrolled. Postoperative pathological assessments will include immunohistochemical (IHC) analysis for mismatch repair (MMR) protein expression (MLH1, PMS2, MSH2, and MSH6).
In cases showing loss of MLH1 and PMS2 expression, BRAF mutation testing will be performed. If BRAF mutation is detected, MLH1 promoter methylation analysis will follow. A positive result in both tests will suggest a sporadic etiology, whereas the absence of both findings will lead to referral for germline genetic testing using next-generation sequencing (NGS) to investigate Lynch syndrome.
For patients with isolated MSH2 and/or MSH6 loss, direct referral to genetic testing will be carried out without BRAF or methylation testing.
Patients with intact MMR expression will be recorded as the MMR-proficient control group. Comparative analysis will be conducted between dMMR and MMR-proficient patients, including demographic characteristics (age, sex, family history of cancer), tumor staging, anatomical location, and presence of metastases.
The primary outcome is to determine the incidence of Lynch syndrome among surgically treated colorectal cancer patients in Türkiye and to identify clinical and pathological correlations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dmmr | – | Diagnostic Test: diagnostic testdmmr |
| mmr expression normal | – | –mmr expression normal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) who undergo surgical resection for histologically confirmed colorectal adenocarcinoma at tertiary hospitals in Türkiye. Participants will include both elective and emergency surgical cases. All patients will have their tumor samples evaluated for MMR protein expression by immunohistochemistry. Patients with abnormal MMR expression will undergo further genetic testing. The population will represent a real-world surgical cohort, including both hereditary and sporadic colorectal cancer cases.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Undergoing surgical resection at one of the participating general surgery departments
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue for MMR analysis
- Consent to participate in the study and undergo genetic testing if indicated
Key exclusion criteria (6 listed)
- Age below 18 years
- Diagnosis other than colorectal adenocarcinoma
- Incomplete or unavailable postoperative pathology results
- Inadequate tissue samples for IHC analysis
- Patients who decline participation in the study at any point
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 |
|---|---|---|
| diagnostic testGroup 1: MMR-Proficient Group Label: MMR-Proficient Description: Patients with normal expression of MMR proteins on IHC analysis. No indication for further genetic testing. Type: Observational Group Group 2: dMMR Group Label: dMMR Description: Patients with loss of MMR protein expression (MLH1, PMS2, MSH2, or MSH6) on IHC. These patients will undergo further molecular or genetic analysis to evaluate for Lynch syndrome. Type: Observational Group | Diagnostic test | dmmr |
Primary outcome
Incidence of Lynch Syndrome Among Surgically Treated Colorectal Cancer Patients
Time frame: Within 12 months following surgical resection and pathological assessment
The primary outcome is to determine the incidence of Lynch syndrome in patients who undergo surgery for colorectal cancer. The diagnosis will be based on initial immunohistochemical (IHC) analysis of MMR protein expression (MLH1, PMS2, MSH2, MSH6), followed by molecular and germline testing (BRAF mutation, MLH1 promoter methylation, and next-generation sequencing) when indicated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer and Hereditary Diseases, run by Izmir Ataturk Training and Research Hospital.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Lynch Syndrome Among Surgically Treated Colorectal Cancer Patients (time frame: Within 12 months following surgical resection and pathological assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.