Hereditary Colorectal and Associated Tumor Registry Study

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.

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Key information

Conditions

Lynch Syndrome Colonic Diseases Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms FAP Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Hereditary Diffuse Gastric Cancer Hyperpigmentation Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Juvenile Polyposis Syndrome Lentigo Melanosis Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Nutritional and Metabolic Diseases Peutz-Jeghers Syndrome Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms

Age range

8 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Identified gene mutation
Personal history of colorectal cancer diagnosed ≤ 50
Personal history of cancer with tumor studies suggestive of Lynch syndrome
Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
Personal history of one of the above cancers and a family history of one or more of the above cancers
Personal or family history of diffuse gastric cancer
From a known genetic predisposition family
Personal history of > 10 colon adenomas (cumulative over a lifetime)
Personal history of any number of hamartomatous polyps
Personal history of multiple large (> 1cm) serrated polyps to right of sigmoid

Exclusion critera:

Individuals under the age of 8
Individuals who cannot travel to Pittsburgh for in-person enrollment
Individuals who cannot provide informed consent

Treatment and study plan

Research Registry

Other

Information regarding medical and family history is stored in the registry to be used for potential future studies

Primary outcomes

Establish a Hereditary Colorectal Tumor Registry to facilitate development and implementation of epidemiological, clinical and cancer control research.

Time frame: 1-N/A (up to 8 years)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Mar 12, 2008
Registry last updated: Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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