RetinoschisisNCT02317354
People s Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
An observational study of Retinoschisis and X-Linked, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: -X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials Objective: -To learn more about how people think and… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Retinoschisis, X-Linked
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2014to 20 Nov 2017
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants may be eligible to take part in this study if they:
- Are 18 years of age or older.
- Have a molecular diagnosis of XLRS and are eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
- Are able to understand and comply with the procedures of this study.
Who cannot join
- Participants may not be able to take part in this study if they:
- Have eye findings or other medical conditions that would preclude consideration for participation in a Phase I/II ocular gene transfer clinical trial.
- Are receiving experimental treatment for XLRS in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Patient Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
Background:
-X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials
Read more
Objective:
-To learn more about how people think and feel about taking part in early phase research.
Eligibility:
-Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
Design:
- Participants will be screened for the XLRS gene transfer study. They will be interviewed:
- Eligible participants who join the study - before the gene transfer procedure, then 3 months and 12 months after it.
- Eligible participants who do not join the study - after their screening visit and 3 months and 12 months later.
<TAB>- Participants who are screened but ineligible - after their screening visit.
<TAB>- Participants who choose not to be screened - at the time they make the decision and 1 year later.
- Interviews will ask for the participants thoughts about the clinical trial and why they chose to take part or not. The interviews will be recorded.
- On the day of interview 1, participants will fill out a survey about their mood and personality.
- On the days of interviews 2 and 3, participants will fill out a survey about their mood.
- Interviews may be done in person or by phone. Surveys can be done online or through the mail. Or they can be done in person at the NIH Clinical Center.
Read the detailed description
Objective: The objective of this study is to understand the factors that influence patient expectations when enrolling in an early-phase RS1 ocular gene transfer clinical trial and to assess the psychological impact of patient expectations over time.
Study Population: Up to 50 adults with X-linked retinoschisis who are eligible to be screened for a Phase I/II ocular gene transfer clinical trial will be included in this study. We hope to capture the experience of those actively engaged in the decision-making process who may choose not to participate in the clinical trial or who may receive gene transfer.
Design: This is a prospective qualitative interview study with quantitative questionnaires. Participation will involve up to three interviews with questionnaires over one year. Interviews may take place in person at the National Institutes of Health Clinical Center (NIH CC) or by telephone and will focus on how the interviewee came to the decision to participate (not to participate) in the early-phase ocular gene transfer trial. Interviews will be transcribed verbatim, coded by two independent coders, and analyzed thematically. Participants will also be asked to complete a questionnaire that measures dispositional optimism, resilience, and general mood states using instruments that have been shown to be valid and reliable in both the general population and in clinical samples. Information collected from these surveys will supplement information collected during the qualitative interview and will provide information about constructs that are difficult to assess during a brief interview.
Outcome Measures: The primary outcomes of this study include a description of what research participants expect when choosing to enroll in an early-phase clinical trial and a description of the psychological impact, over time, of having high expectations
- Conditions
- Retinoschisis, X-Linked
- Keywords
- X-Linked, Retinoschisis
- Medical subject headings
- Retinoschisis
What is being measured
The primary outcome is the main question the study is designed to answer.
Desc. expectation pt enroll ct
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study start13 Dec 2014
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RetinoschisisStudies of the same condition, open and under way.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amy E Turriff, Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317354
- Sponsor's protocol ID
- 150041
- Other IDs
- 15-EI-0041
- Status last verified
- 20 Nov 2017
- First submitted
- 13 Dec 2014
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Jansen LA. Two concepts of therapeutic optimism. J Med Ethics. 2011 Sep;37(9):563-6. doi: 10.1136/jme.2010.038943. Epub 2011 May 7.
PubMed 21551464Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5(3-4):319-29. doi: 10.1016/0160-2527(82)90026-7. No abstract available.
PubMed 6135666
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Expectations When Enrolling in a Phase I/II RS1 Ocular Gene Transfer Clinical Trial
- ClinicalTrials.gov ID
- NCT02317354
- Acronym / sponsor ID
- 150041
- Conditions
- Retinoschisis, X-Linked
- Keywords
- X-Linked, Retinoschisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 13 Dec 2014
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 16 Dec 2014 (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.
Background:
-X-linked retinoschisis (XLRS) is an inherited eye condition. Researchers want to learn more about how people with XLRS choose to take part in research studies. They hope to find ways to help other people make decisions about joining early phase trials
Objective:
-To learn more about how people think and feel about taking part in early phase research.
Eligibility:
-Adults age 18 or older with diagnosed XLRS. They must be eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
Design:
- Participants will be screened for the XLRS gene transfer study. They will be interviewed:
- Eligible participants who join the study - before the gene transfer procedure, then 3 months and 12 months after it.
- Eligible participants who do not join the study - after their screening visit and 3 months and 12 months later.
<TAB>- Participants who are screened but ineligible - after their screening visit.
<TAB>- Participants who choose not to be screened - at the time they make the decision and 1 year later.
- Interviews will ask for the participants thoughts about the clinical trial and why they chose to take part or not. The interviews will be recorded.
- On the day of interview 1, participants will fill out a survey about their mood and personality.
- On the days of interviews 2 and 3, participants will fill out a survey about their mood.
- Interviews may be done in person or by phone. Surveys can be done online or through the mail. Or they can be done in person at the NIH Clinical Center.
Detailed description
Objective: The objective of this study is to understand the factors that influence patient expectations when enrolling in an early-phase RS1 ocular gene transfer clinical trial and to assess the psychological impact of patient expectations over time.
Study Population: Up to 50 adults with X-linked retinoschisis who are eligible to be screened for a Phase I/II ocular gene transfer clinical trial will be included in this study. We hope to capture the experience of those actively engaged in the decision-making process who may choose not to participate in the clinical trial or who may receive gene transfer.
Design: This is a prospective qualitative interview study with quantitative questionnaires. Participation will involve up to three interviews with questionnaires over one year. Interviews may take place in person at the National Institutes of Health Clinical Center (NIH CC) or by telephone and will focus on how the interviewee came to the decision to participate (not to participate) in the early-phase ocular gene transfer trial. Interviews will be transcribed verbatim, coded by two independent coders, and analyzed thematically. Participants will also be asked to complete a questionnaire that measures dispositional optimism, resilience, and general mood states using instruments that have been shown to be valid and reliable in both the general population and in clinical samples. Information collected from these surveys will supplement information collected during the qualitative interview and will provide information about constructs that are difficult to assess during a brief interview.
Outcome Measures: The primary outcomes of this study include a description of what research participants expect when choosing to enroll in an early-phase clinical trial and a description of the psychological impact, over time, of having high expectations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are 18 years of age or older.
- Have a molecular diagnosis of XLRS and are eligible to be screened for a Phase I/II ocular gene transfer clinical trial.
- Are able to understand and comply with the procedures of this study.
Key exclusion criteria (3 listed)
- Have eye findings or other medical conditions that would preclude consideration for participation in a Phase I/II ocular gene transfer clinical trial.
- Are receiving experimental treatment for XLRS in another research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Desc. expectation pt enroll ct
Time frame: Study Completion
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 9 Dec 2019.
- Background: PubMed 21551464Jansen LA. Two concepts of therapeutic optimism. J Med Ethics. 2011 Sep;37(9):563-6. doi: 10.1136/jme.2010.038943. Epub 2011 May 7.
- Background: PubMed 6135666Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982;5(3-4):319-29. doi: 10.1016/0160-2527(82)90026-7. No abstract available.
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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.
Amy E Turriff principal investigator
National Eye Institute (NEI)
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 Retinoschisis and X-Linked, run by National Eye Institute (NEI) 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 4 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: finished, as of the sponsor's last update on 9 Dec 2019. 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?
Desc. expectation pt enroll ct (time frame: Study Completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317354, which also lists 2 linked publications.
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 9 Dec 2019.