Tumor Genomic ProfilingNCT02713334
Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling
An observational study of Tumor Genomic Profiling, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The objective of this protocol is to characterize cancer patients' responses to learning their secondary findings arising from tumor genomic profiling, and the process and outcomes of their decisions to communicate these results to their families. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tumor Genomic Profiling
- What is being tested?
- survey and semi-structured interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2016to 25 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 300 participants for the proposed study from those already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.
Who may be able to join
- Patients (Phase I):
- 18 years of age or older
- Has consented to MSK IRB protocol #12-245, Consent A and Part C
- Has not received secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or patient report
- Diagnosed with a solid tumor as per EMR and/or clinician judgment
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
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- Family members (Phase I):
- 18 years of age or older as per self report
- Nominated by the patient participant as a family member with whom the secondary findings have been shared (spouses/partners are eligible as "family members" for the purposes of this study)
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- Patients (Phase 2):
- 18 years of age of older
- Has consented to MSK IRB protocol #12-245, Consent Part A and C
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefor, participants must be able to communicate in English to complete the surveys.
- AYA Survivors of Pediatric Cancers (Phase 3):
- Age 15 to 30 years old
- Are at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
- Has consented or provided assent to MSK IRB protocol #12-245, Consent Part A and C
- Has received pathogenic secondary findings as a result of MSK IRB protocol #12- 245, Consent Part C as per EMR and/or CGS care provider report
- Participated in a CGS consultation following receipt of secondary findings
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- Adult Caregivers of Survivors of Pediatric Cancers (Phase 3):
- 18 years of age or older
- Are the caregiver of a child who was treated for pediatric cancer (i.e., any cancer diagnosed before age 18). Caregiver status is based on either: 1) nomination as such by a young adult survivor (i.e., age 18+), 2) having consented on behalf of a minor child (i.e., age <18) to MSK IRB protocol
- #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child, or 3) nomination by the adult who consented on behalf of a minor child (i.e., age <18) to MSK IRB protocol #12-245 Part A and C plus self-reported confirmation that s/he is the caregiver for the child
- That child is currently alive and at least 1 year post-treatment for pediatric cancer (i.e., any cancer diagnosed before age 18)
- Has consented on behalf of that child, or that child consented, to MSK IRB protocol #12-245, Consent Part A and C
- That child received pathogenic secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or CGS healthcare provider report
- Participated in a CGS consultation following receipt of secondary findings
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys
Who cannot join
- Received genetic testing in the past that resulted in a pathogenic finding or a variant of unknown significance as reported in the EMR.
- Major psychiatric illness or cognitive impairment that in the judgment of the investigator or study staff would preclude study participation
- Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
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
The objective of this protocol is to characterize cancer patients' responses to learning their secondary findings arising from tumor genomic profiling, and the process and outcomes of their decisions to communicate these results to their families.
Read the detailed description
For Phase 1 of this study, the investigators will conduct a prospective, observational study with cancer patients undergoing tumor genomic profiling (n = 300) and their family members (anticipated n ≈ 150). Data collection will occur through an embedded mixed methods design, in which both quantitative (i.e., survey) and qualitative (i.e., semi-structured interview) data are collected at the same timepoint in order to obtain a more complete understanding of specific processes and outcomes.
They will be recruited from those who already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.
For Phase 2 of this study, participants (n=500) who have received pathogenic secondary findings through protocol #12-245 will be recruited.
For Phase 3, efforts will be expanded from the adult populations explored in the preceding phases to the experiences of patients affected by pediatric cancers and their families. Cross-sectional mixed methods data from AYA survivors of pediatric cancers (n=50) and adult caregivers of survivors of pediatric cancer (n=50) will be collected.
- Conditions
- Tumor Genomic Profiling
- Being tested
- survey, semi-structured interview
- Keywords
- Decision Making, Communication, 16-080
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyBehavioural
semi-structured interviewBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators will assess patients' emotional responses to receiving their secondary findings
Through quantitative (i.e., survey) assessments, the investigators will assess patients' emotional (both positive and negative) responses to receiving their secondary findings, and their perceptions regarding the utility of this information and communicating it to family.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start25 Feb 2016
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Genomic ProfilingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jada Hamiliton, PhD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713334
- Sponsor's protocol ID
- 16-080
- Status last verified
- May 2026
- First submitted
- 15 Mar 2016
- Last updated
- 26 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patients Decision Making and Family Communication About Secondary Findings From Tumor Genomic Profiling
- ClinicalTrials.gov ID
- NCT02713334
- Acronym / sponsor ID
- 16-080
- Conditions
- Tumor Genomic Profiling
- Keywords
- Decision Making, Communication, 16-080
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 25 Feb 2016
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 18 Mar 2016 (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.
The objective of this protocol is to characterize cancer patients' responses to learning their secondary findings arising from tumor genomic profiling, and the process and outcomes of their decisions to communicate these results to their families.
Detailed description
For Phase 1 of this study, the investigators will conduct a prospective, observational study with cancer patients undergoing tumor genomic profiling (n = 300) and their family members (anticipated n ≈ 150). Data collection will occur through an embedded mixed methods design, in which both quantitative (i.e., survey) and qualitative (i.e., semi-structured interview) data are collected at the same timepoint in order to obtain a more complete understanding of specific processes and outcomes.
They will be recruited from those who already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.
For Phase 2 of this study, participants (n=500) who have received pathogenic secondary findings through protocol #12-245 will be recruited.
For Phase 3, efforts will be expanded from the adult populations explored in the preceding phases to the experiences of patients affected by pediatric cancers and their families. Cross-sectional mixed methods data from AYA survivors of pediatric cancers (n=50) and adult caregivers of survivors of pediatric cancer (n=50) will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 300 participants for the proposed study from those already enrolled in protocol #12-245, and who agree to receive their secondary findings through Consent Part C of this existing protocol.
Key inclusion criteria (30 listed)
- 18 years of age or older
- Has consented to MSK IRB protocol #12-245, Consent A and Part C
- Has not received secondary findings as a result of MSK IRB protocol #12-245, Consent Part C as per EMR and/or patient report
- Diagnosed with a solid tumor as per EMR and/or clinician judgment
- English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Key exclusion criteria (3 listed)
- Received genetic testing in the past that resulted in a pathogenic finding or a variant of unknown significance as reported in the EMR.
- Major psychiatric illness or cognitive impairment that in the judgment of the investigator or study staff would preclude study participation
- Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
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 |
|---|---|---|
| survey | Behavioural | – |
| semi-structured interview | Behavioural | – |
Primary outcome
The investigators will assess patients' emotional responses to receiving their secondary findings
Time frame: 1 year
Through quantitative (i.e., survey) assessments, the investigators will assess patients' emotional (both positive and negative) responses to receiving their secondary findings, and their perceptions regarding the utility of this information and communicating it to family.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- 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.
Jada Hamiliton, PhD, MPH 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 Tumor Genomic Profiling, 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 30 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The investigators will assess patients' emotional responses to receiving their secondary findings (time frame: 1 year). 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 26 May 2026.