NCT01447199

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1994

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
17.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

26.1 years

First QC Date

October 4, 2011

Last Update Submit

January 5, 2020

Conditions

Bladder CancerColorectal CancerEndometrial CancerKidney CancerSkin CancerUterus Cancer

Keywords

Bladder cancerColorectal cancerEndometrial cancerKidney cancerSkin cancerUterus cancerMolecular PredispositionHereditary Nonpolyposis Colon CancerHNPCCMolecular genetic testingGene mutationsMutation analysesGenetic polymorphismsFamily history of cancerEarly age of cancer onsetLittle/no personal or family history of cancerSpousesQuestionnairesBlood sampleSaliva Sample

Outcome Measures

Primary Outcomes (1)

  • 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 Arms (3)

Gene Mutation

Group with increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset.

Behavioral: Health and Diet Questionnaire

No Cancer History

Group with little/no personal or family history of cancer.

Behavioral: Health and Diet Questionnaire

Spouses

Spouses of those who may have an increased risk for developing colorectal and/or other cancers as the result of an inherited gene mutation, family history of cancer, or an early age of cancer onset, or little/no personal or family history of cancer.

Behavioral: Health and Diet Questionnaire

Interventions

Health and Diet QuestionnaireBEHAVIORAL

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

Also known as: Survey
Gene MutationNo Cancer HistorySpouses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • 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.
  • 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).
  • Any patient diagnosed with CRC and/or any HNPCC-related cancers less than or equal to 45 years of age.
  • Greater than or equal to age 18 at time of study.
  • 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.
  • 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.
  • 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.

You may not qualify if:

  • Diagnosis of current major psychiatric disorder, per DSM-III-R (or DSM IV).
  • Age less than 18 years at time of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Participants will have a single sample (8-10 teaspoons) of blood collected at M. D. Anderson, depending upon current health status. In the case of individuals not coming to the clinic, a blood drawing kit will be sent to the participant's home, which will include instructions and a postage-paid return express mail envelope. If participant unable or unwilling to give a blood sample, saliva samples can be collected instead.

MeSH Terms

Conditions

Urinary Bladder NeoplasmsColorectal NeoplasmsEndometrial NeoplasmsKidney NeoplasmsSkin NeoplasmsUterine NeoplasmsColorectal Neoplasms, Hereditary Nonpolyposis

Interventions

HealthSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, FemaleUterine DiseasesGenital Diseases, FemaleGenital DiseasesKidney DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Patrick Lynch, MD, JD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 6, 2011

Study Start

September 1, 1994

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

US(1)