Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
Comportemental Data
+ behavioral Data
+ behavioral Data
Données recueillies dès le début de l'étude - ProspectiveFamiliale
Étude au sein de familles pour explorer l'impact de l'hérédité et du mode de vie commun sur la santé.Résumé
Date de début de l'étude : 1 septembre 2012
Date à laquelle le premier participant a commencé l'étude.This study uses new methods called "genome sequencing" that allow the investigators to study part or all of a person's genome. The genome is the collection of all of a person's genes. Genes carry the instructions that our bodies need to develop and function. Genes are passed on from one generation to the next. Genome sequencing can study all of a person's genome (whole genome sequencing) or just parts of their genome (whole exome sequencing). In the study, the investigators refer to all these research methods as 'genome sequencing'. Genome sequencing typically shows a large number of gene changes, known as "variants." Some (but not all) of these genetic variants may be linked to increased risks of diseases other than cancer. The purpose of this study is to learn what kinds of genetic variants the patient wants to learn about from their genome.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.8 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Familiale
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Inclusion Criteria: Cancer survivors (sample #1): Consented individuals with a personal history of cancer enrolled on protocols 09-068 or 96-051 who have indicated their interest in participating in future research or learning their results, defined as either: For samples #1-2: checking "yes" to the re-contact question in their consent form; or, checking "I wish to know these results" in their consent form. Unaffected Relatives (sample #2): Consented individuals with no personal history of cancer enrolled on protocols 09-068 and 96-051 (parents or siblings of probands) who have indicated their interest in participating in future research or learning their results, defined as either: checking "yes" to the re-contact question in their consent form or, checking "I wish to know these results" in their consent form Focus group participants (sample #3- hypothetical group): Individuals with or without a personal history of cancer Exclusion Criteria: Non-English speakers; or, Individuals < 18 years of age; or Individuals unable to complete the follow-up assessments (e.g., unavailable to complete questionnaires over the 12-month study period). For samples #1-2: Individuals who indicate in their consent form that they do not want to checking "no" to the re-contact question in their consent form; or, checking "I prefer not to know these results" in their consent form Cases where it is unclear whether individuals' are interested in participating in future research or learning their results, defined as: Not answering the re-contact question in their consent form (i.e., left blank); or, Not answering the re-contact question because it did not exist in the version of the consent form that was originally signed (i.e., re-contact question missing).
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps