Clinical trial · Observational
A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| History of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| qualitative interviews | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Unaffected Relatives
- description
- We will use a prospective, observational cohort design, we will invite a sample of individuals who have indicated willingness to be re-contacted for future studies (from existing protocols involving cancer survivors and their unaffected relatives employing mixed methods -qualitative interviews coupled with validated measures - to assess: the proportion of participants experiencing psychological distress from Whole genome/exome sequencing (WGS/WES) results.
- interventionNames
- Behavioral: qualitative interviews
- label
- Pts with history of cancer
- description
- We will use a prospective, observational cohort design, we will invite a sample of individuals who have indicated willingness to be re-contacted for future studies (from existing protocols involving cancer survivors and their unaffected relatives employing mixed methods -qualitative interviews coupled with validated measures - to assess: the proportion of participants experiencing psychological distress from Whole genome/exome sequencing (WGS/WES) results.
- interventionNames
- Behavioral: qualitative interviews
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available