Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bladder cancer clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bladder cancer clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bladder Cancer Clinical Trial in Houston TX

NCT01447199 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bladder cancer clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bladder cancer clinical study, and could be compensated for your time.

Active not recruiting

Male & Female

18 Years +

This study is looking to recruit 2000 Participants

The goal of this study is to understand factors which may influence risk for colorectal and other cancers in families. These factors include genetic variability, in combination with diet and lifestyle. In order to achieve these goals, we need to contact as many eligible participants as possible.

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Details for the study

Population

Referrals from Departments of GI Oncology, GI Medicine and Nutrition, GI Surgery, GYN Oncology, Cancer Prevention and from the Genetic Counselors at UT MD Anderson Cancer Center, families and spouses.

Brief Title

The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)

Official Title

The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)

Brief Summary

The goal of this study is to understand factors which may influence risk for colorectal and<br /> other cancers in families. These factors include genetic variability, in combination with<br /> diet and lifestyle. In order to achieve these goals, we need to contact as many eligible<br /> participants as possible.

Detailed Description

If you agree to take part in this study, you will have a single sample (8-10 teaspoons) of
blood collected, depending upon current health status. The blood will be drawn at MD
Anderson. If you cannot come to the clinic, a blood drawing kit will be sent to the your
home, which will include instructions and a postage-paid return express mail envelope.
Phlebotomy charges connected to this study will be paid by the study. The blood sample will
be sent to a research laboratory at MD Anderson for analyses. If you are unwilling or unable
to give a blood sample, you can give a saliva sample instead. In this case, a kit will be
mailed to you with instructions for obtaining the saliva sample. A prepaid envelope will be
included for its return. Participants who previously participated in Protocol PA11-0567 and
provided a blood sample do not need to provide another blood sample. The previously stored
blood sample collected by Protocol PA11-0567 may be used.

You will be asked to answer a series of questions. These questions will ask about foods eaten
either one year ago or one year before the first diagnosis of cancer. There will also be
questions about cooking methods as well as overall health, and vitamin and medication use.
Some of the questions are personal, but all answers will be kept strictly private.

The questionnaire will be sent to your home via U.S. or express mail. It may take several
hours to complete the survey, but there is no time limit on its completion. There are no
right or wrong answers to the questions. A postage-paid return envelope will be provided for
the return of the questionnaire.

Solid tumor material and colonoscopy specimens of normal tissue will be collected from
participants requiring either colonoscopy or surgery for routine clinical reasons. The tumor
fragments will be collected from specimens. Tissue required for a clinical pathology
diagnosis will not be used for research purposes.

This is an investigational study. About 2,000 patients and family members will take part in
this study. All will be enrolled at MD Anderson.

Treatments and/or Procedures

Health and diet questionnaire

Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Time to Onset for Colorectal Cancer

Primary endpoint is time to onset for colorectal cancer using Cox proportional hazard regression for determining the role that polymorphic variants of genes have on risk for development of HNPCC at an early age.

Overall study period up to 15 years.

Study 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.

8. Lynch Syndrome patients identified and recruited through Protocol PA11-0567 who opt
into Optional Procedure B, which consents the patient to participate in this study.

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.