Hereditary Colorectal and Associated Tumor Registry Study

NCT00633607 | Completed DMC

• 1 other identifier: 04-112
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lynch Syndrome; FAP; Hereditary Diffuse Gastric Cancer; Juvenile Polyposis Syndrome; Peutz-Jeghers Syndrome

Outcome Measures

Primary Outcomes (1)

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

  1-N/A (up to 8 years)

Interventions

Research Registry OTHER

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

Eligibility Criteria

• Age: 8 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects are recruited from our Hereditary GI clinic.

You may qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and extracted DNA are stored for potential future studies.

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Stomach Neoplasms; Juvenile polyposis syndrome; Peutz-Jeghers Syndrome

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Stomach Diseases; Intestinal Polyposis; Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Randall E Brand, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 12, 2008
• Study Start: April 1, 2012
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (1)