History of CancerNCT01692223
A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
An observational study of History of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- History of Cancer
- What is being tested?
- qualitative interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from cohorts of patients whose DNA samples are being examined with WGS/WES as part of efforts to identify novel cancer susceptibility alleles. Participants will be derived from the following protocols: 09-068 and 96-051. We will also recruit an additional group of participants (up to 100) from the general public (with or without a cancer history) who have not had their genomes or exomes sequenced to participate in focus groups to inform us about their perceptions of the hypothetical utility of learning of incidental results from their genome or exomes.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
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
- History of Cancer
- Being tested
- qualitative interviews
- Keywords
- Personal genomics, Genome Sequencing Results, 12-167
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative interviewsBehavioural
Also called (Continued from Intervention Description) The RSA will call each participant to assess changes in health behavior and, service use at 3-,6- & 12-month timepoints after the results session. Distress, will also be re-assessed at 6 & 12-month timepoints after the results session., The interviewer will call willing participants to complete an open-ended, in-depth
A week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety \& Depression Scale (HADS), revised Impact of Events Scale (IES-R), \& a questionnaire about their health behaviors, to establish baseline distress levels \& health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider \& discuss resultant therapeutic \& management recommendations for the participants \& their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview.
| Study group | Role | What they receive |
|---|---|---|
| Unaffected Relatives | 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. Receives: Behavioral: qualitative interviews | |
| Pts with history of cancer | 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. Receives: Behavioral: qualitative interviews | |
| Participants whose genomes/exomes are not sequenced | We will also recruit an additional group of participants from the general public (with or without a cancer history) who have not had their genomes or exomes sequenced to participate in focus groups to inform us about their perceptions of the hypothetical utility of learning of incidental results from their genome or exomes. For our sampling purposes, this group of participants is referred to as the 'focus group participants (sample #3-hypothetical group) Receives: Behavioral: qualitative interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety \& Depression Scale (HADS; score > or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for History of CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Robson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692223
- Sponsor's protocol ID
- 12-167
- Status last verified
- Aug 2018
- First submitted
- 20 Sep 2012
- Last updated
- 2 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Genomics: A Safety Study Assessing the Effects of Receiving Genome Sequencing Results
- ClinicalTrials.gov ID
- NCT01692223
- Acronym / sponsor ID
- 12-167
- Conditions
- History of Cancer
- Keywords
- Personal genomics, Genome Sequencing Results, 12-167
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unaffected Relatives | – | Behavioral: qualitative interviewsWe 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. |
| Pts with history of cancer | – | Behavioral: qualitative interviewsWe 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. |
| Participants whose genomes/exomes are not sequenced | – | Behavioral: qualitative interviewsWe will also recruit an additional group of participants from the general public (with or without a cancer history) who have not had their genomes or exomes sequenced to participate in focus groups to inform us about their perceptions of the hypothetical utility of learning of incidental results from their genome or exomes. For our sampling purposes, this group of participants is referred to as the 'focus group participants (sample #3-hypothetical group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from cohorts of patients whose DNA samples are being examined with WGS/WES as part of efforts to identify novel cancer susceptibility alleles. Participants will be derived from the following protocols: 09-068 and 96-051. We will also recruit an additional group of participants (up to 100) from the general public (with or without a cancer history) who have not had their genomes or exomes sequenced to participate in focus groups to inform us about their perceptions of the hypothetical utility of learning of incidental results from their genome or exomes.
Key inclusion criteria (10 listed)
- 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.
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative interviewsAlso: (Continued from Intervention Description) The RSA will call each participant to assess changes in health behavior and, service use at 3-,6- & 12-month timepoints after the results session. Distress, will also be re-assessed at 6 & 12-month timepoints after the results session., The interviewer will call willing participants to complete an open-ended, in-depthA week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety \& Depression Scale (HADS), revised Impact of Events Scale (IES-R), \& a questionnaire about their health behaviors, to establish baseline distress levels \& health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider \& discuss resultant therapeutic \& management recommendations for the participants \& their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview. | Behavioural | Participants whose genomes/exomes are not sequenced, Pts with history of cancer, Unaffected Relatives |
Primary outcome
Psychological distress
Time frame: 2 years
of receiving incidentally identified disease risk results from whole genome/exome sequencing. Safety is defined as no more than 20% of participants experiencing clinically meaningful levels of distress at 1 week follow-up, as measured by the Hospital Anxiety \& Depression Scale (HADS; score > or = to 8 on the anxiety sub-scale). Patients will be considered evaluable for the primary outcome if they are not distressed at baseline and have completed the 1 week follow-up assessment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Robson, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of History of Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.