Symptoms and General Pathology

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Patient that has or is at risk for Lynch Syndrome.

Follow-up questionnaire done once a year for five years.

Questionnaire

Karen H. Lu, MD

The goal of this study is to create a registry of information about women who have or are at risk for Lynch syndrome, in order to study gynecologic cancer risks.

This is an investigational study. Up to 1000 patients will take part in this study. All patients will be enrolled at MD Anderson.

Lynch Syndrome:

In women with hereditary non-polyposis colorectal cancer syndrome (HNPCC), also called Lynch syndrome, the lifetime risk for endometrial cancer increases to 40-60%, and the risk for ovarian cancer increases to 12%.

Study Procedures:

If you agree to take part in this study, basic medical and family information will be collected. You will be asked to fill out a baseline (starting) questionnaire, which will ask personal information such as age, ethnic background, medical and family history, and health habits. All information will be kept confidential. Some information may be gathered from your medical record. It should take about 30 minutes to complete this questionnaire.

Once a year for 20 years, you will be asked to complete a follow-up questionnaire. The follow-up questionnaire provides researchers with an opportunity to study possible health issues and/or changes that may have occurred since your last visit. This questionnaire should only take about 15 -20 minutes to complete.

If you have a history of endometrial or ovarian cancer, or develop endometrial or ovarian cancer while on study, researchers will collect copies of the diagnostic and surgery reports from your medical record and will ask you to fill out an additional questionnaire about symptoms of endometrial cancer. This should only take about 15 minutes to complete.

Researchers will also collect several leftover tissue samples from your surgery if you have had surgery. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors. The samples will be kept securely in a lab at MD Anderson.

Before your leftover tissue samples can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your leftover tissue samples must first be approved by the IRB.

Length of Study:

At the end of the study, you may be invited to participate in a follow-up study. During your participation in this registry study, researchers will inform you about related studies for which you might be eligible. You will have the option to take part or not to take part in them. Your active participation in this study will continue for up to 20 years total.

Leftover tissue samples will be collected from surgery performed. These samples will be stored and used to perform molecular studies to characterize Lynch syndrome tumors.

Registry for Women Who Are At Risk Or May Have Lynch Syndrome

M.D. Anderson Cancer Center

No intervention, observational study.

Fränzel van Duijnhoven, PhD

Ellen Kampman, PhD

The GEOLynch cohort study has been established to investigate the influence of genetic, environmental and other factors on tumour risk in persons with Lynch syndrome.

The GEOLynch cohort study includes persons with Lynch syndrome (LS) only. Persons with LS carry an inherited mutation in one of the DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2 which increases their risk of several types of cancer, especially colorectal and endometrial cancer. Additionally, mutations in the EPCAM gene that result in epigenetic silencing of the MSH2 gene cause LS. Since 2006, persons with LS are invited to participate in the GEOLynch cohort study via the Netherlands Foundation for the Detection of Hereditary Tumours, the Radboud University Medical Center Nijmegen or the University Medical Centre Groningen. Moreover, persons with LS can participate in the study after contacting the researcher themselves. Participants are asked to complete a food frequency questionnaire and questionnaires about dietary supplement use, physical activity, weight, height and medication use. A buccal swab was asked of every participant recruited between 2006 and 2008. From 2012 on, newly recruited participants are asked to donate a blood sample instead of a buccal swab. Furthermore, participants who had been recruited between 2006 and 2008 were asked to complete the questionnaires again and to donate a blood sample too. Hence, follow-up measurements are available for a subset of participants. DNA has been subtracted from the buccal swabs to genotype SNPs of the IGF gene axis and polymorphisms of MTHFR C377T. Blood samples are biobanked to facilitate future analyses of biomarkers, nutrients, DNA etc. Clinical characteristics regarding performed colonoscopies and tumour diagnoses of all participants is gathered from medical records and a linkage to the nationwide network and registry of histo- and cytopathology in the Netherlands (PALGA Foundation ). Hazard ratios will be calculated to investigate the influence of genetic, environmental and other factor on tumour risk. Repeated measures analyses will be used if follow-up measurements are taken into account.

The GEOLynch Cohort Study

The GEOLynch Cohort Study: Genetic, Environmental and Other Factors That Influence Tumour Risk Among Persons With Lynch Syndrome

All diagnosed colorectal adenomas and carcinomas described in paticipants' medical reports and/or pathology reports.

All diagnosed endometrial cancers described in participants' medical reports and/or pathology reports.

All diagnosed cancer types described in participants' medical reports and/or pathology reports.

Wereld Kanker Onderzoek Fonds

Dutch Cancer Society

Funding: Biobanking and BioMolecular resources Research Infrastructure The Netherlands

Wageningen University

Adenomatous Polyposis Coli

Colitis

Colitis, Ulcerative

Ulcer

Familial Adenomatous Polyposis

MYH-associated Polyposis

Patients who have had their IPAA procedures performed by Dr. Becker

James M Becker, MD

Francis A Farraye, MD

Arthur F Stucchi, PhD

Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.

In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.

Ileal Pouch-Anal Anastomosis Registry

Ileal Pouch-Anal Anastomosis (IPAA) Registry

Participants will be queried once per year as to the status of their intestinal pouch. Patients will have either a functional pouch or a non-functional pouch. A pouch will be considered functional if patient is not temporarily or permanently diverted to an ileostomy.

Participants will be queried once per year as to their quality of life using the IBDQ-10.

Participants will be queried once per year regarding health issues with pouch such as pouchitis, stricture and fistula. Participants will also be asked about presence of co-morbidities such as hypertension, diabetes and arthritis.

Boston Medical Center

Faculty member

Microsatellite Instability

Education for professionals

Distribution of educational materials

Feedback for professionals

Reminders for professionals

Lucy I Overbeek, MSc

Nicoline Hoogerbrugge, MD PhD

Stan J Ketelaars, MD

Els JM Ahsmann, MD PhD

Jos Meijer, MD

Paul Blok, MD PhD

Pieter J Westenend, MD PhD

Ineke van Lijnschoten, MD PhD

Sietske Riemersma, MD

Ton Tiebosch, MD PhD

Cilia M Ferrier, MD PhD

Joris J Grond, MD PhD

Erik Thunnissen, MD PhD

Sonja Henzen, MD PhD

Anneke van der Wurff, MD PhD

Rosella P Hermens, MSc PhD

The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.

The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.

Implementation of a New Strategy to Identify HNPCC Patients

Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer

ZonMw: The Netherlands Organisation for Health Research and Development

Radboud University Medical Center

Chao Hsiung, PhD.

Rei-Ping Tang, PhD.

Ling-Ling Hsieh, PhD.

The purpose of this study is to establish the HNPCC related information in Taiwan, and to characterize relevant susceptibility genes related to colorectal cancer to provide better disease control for the high-risk people. To accomplish this objective, we will collect detailed information of the HNPCC patients and their families from the collaborative hospitals and relate the information to the risk of CRC in order to provide sound disease control system in Taiwan.

HNPCC is an autosomal dominant disease that is clinically characterized by the development of colorectal cancer (CRC) at an early age (mean age 44 years old). Four genes have been known to be related to this hereditary disease. It shows an excess of synchronous and metachronous tumors as well as a preponderance of right-sided tumors (70%). Another feature has been seen among the families of the HNPCC patients is the occurrence of adenocarcinomas at other sites (particularly at the endometrial, ovary, stomach, pancreas, ureter, renal pelvis, and skin). Difficulties arise in distinguishing environmental factors and genetic predisposition for familial clustering of CRC. The discovery of HNPCC germline mutations has been momentous in that it enables a clear distinction between carriers and noncarriers for those who were previously assigned a 50% risk of germline mutation. The informed consent provided by patients is important for the process of familial study and the search for germline mutations, these will further provide information for education and counseling. HNPCC has been reported to be responsible for about 1% to 13% of all CRC. The frequency of HNPCC varies by geographical areas. The true incidence of HNPCC in Taiwan area is unclear. From year 1995 to 2000, 50 out of 4500(1.1%) patients were HNPCC according to the Amsterdam I criteria. MMR gene databases are crucial to understand the relationship between genotype and phenotype. Kindred sharing the same mutations but living in different places will provide the information to assess the contribution of environmental factors to colorectal carcinogenesis. The related clinical and basic researches are thus important for understanding the mutation spectrum of MMR genes, interaction between oncogenes, tumor suppressor genes, and roles of genetic polymorphisms in modifying MMR genes in Taiwan.

Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications

Chang Gung Memorial Hospital

National Health Research Institutes, Taiwan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry for Women Who Are At Risk Or May Have Lynch Syndrome	NCT00508573	Hereditary Nonp... Lynch Syndrome	Questionnaire	18 Years -	M.D. Anderson Cancer Center
The GEOLynch Cohort Study	NCT03303833	Lynch Syndrome Neoplasms Hereditary Nonp... Colorectal Neop...	No intervention...	18 Years - 80 Years	Wageningen University
Ileal Pouch-Anal Anastomosis Registry	NCT01026480	Ileal Pouch-Ana...		-	Boston Medical Center
Registry for Women Who Are At Risk Or May Have Lynch Syndrome	NCT00508573	Hereditary Nonp... Lynch Syndrome	Questionnaire	18 Years -	M.D. Anderson Cancer Center
Ileal Pouch-Anal Anastomosis Registry	NCT01026480	Ileal Pouch-Ana...		-	Boston Medical Center
Implementation of a New Strategy to Identify HNPCC Patients	NCT00141466	Colorectal Neop... Hereditary Nonp...	Education for p... Distribution of... Feedback for pr... Reminders for p...	-	Radboud University Medical Center
Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications	NCT00262171	Hereditary Nonp...		20 Years -	National Health Research Institutes, Taiwan

Spots Global Cancer Trial Database for hereditary nonpolyposis colorectal cancer