The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01447199
• Date of registration: 04/10/2011
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
• Scientific title: The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)
• Date of first enrolment: September 1994
• Target sample size: 2000
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01447199
• Study type: Observational
• Study design: Observational Model: Family-Based, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Patrick Lynch, MD, JD

• Name: Patrick Lynch, MD, JD
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All patients with a new referral for a diagnosis of colorectal cancer
(adenocarcinoma) and/or HNPCC-related cancers at the UTMDACC will be considered
potentially eligible for this study regardless of prior treatment.

2. Families maintained at the UTMDACC Hereditary Colon Cancer Registry that have a known
germline mutation in a mismatch repair gene or contain two or more first degree
relatives diagnosed with CRC and/or any HNPCC-related cancers, one of whom must be
less than or equal to 50 years at diagnosis.

3. First-degree and more distant relatives of individuals diagnosed with CRC and/or any
HNPCC-related cancers from either of the groups in 1 and 2 (above).

4. Any patient diagnosed with CRC and/or any HNPCC-related cancers less than or equal to
45 years of age.

5. Greater than or equal to age 18 at time of study.

6. Able to provide informed consent to participate in this study indicating that they
are aware of the investigational nature, in keeping with the policies of this
hospital.

7. Non-HNPCC quartets, defined as parents and two offspring who do not carry a mismatch
repair gene mutation. These non-HNPCC quartets should have no personal history of
cancer, nor cancer in any first degree relatives of the quartet members, nor history
of trinucleotide repeat syndromes. Non-HNPCC parents in a quartet should be less than
34 years old at the time the offspring were born.

Exclusion Criteria:

1. Diagnosis of current major psychiatric disorder, per DSM-III-R (or DSM IV).

2. Age less than 18 years at time of enrollment.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bladder Cancer

Colorectal Cancer

Endometrial Cancer

Kidney Cancer

Skin Cancer

Uterus Cancer

Intervention(s)

Behavioral: Health and Diet Questionnaire

Primary Outcome(s)

Time to Onset for Colorectal Cancer [Time Frame: Overall study period up to 15 years.]

Secondary ID(s)

DM94-060

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)