Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

The Molecular Predisposition to Hereditary Nonpolyposis Colon Cancer (HNPCC)

5 januari 2020 uppdaterad av: M.D. Anderson Cancer Center
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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

2000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • University of Texas MD Anderson Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Beteende: 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.
Andra namn:
  • Undersökning
No Cancer History
Group with little/no personal or family history of cancer.
Beteende: 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.
Andra namn:
  • Undersökning
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.
Beteende: 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.
Andra namn:
  • Undersökning

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Onset for Colorectal Cancer
Tidsram: Overall study period up to 15 years.
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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.D. Anderson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 1994

Primärt slutförande (Förväntat)

30 september 2020

Avslutad studie (Förväntat)

30 september 2020

Studieregistreringsdatum

Först inskickad

4 oktober 2011

Först inskickad som uppfyllde QC-kriterierna

5 oktober 2011

Första postat (Uppskatta)

6 oktober 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DM94-060

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera