Condition or disease | Intervention/treatment |
---|---|
Retinoblastoma Cancer Survivor Biological Sibling Intraocular Retinoblastoma Unilateral Retinoblastoma | Procedure: Biospecimen collection Other: Vision assessment Other: Questionnaire administration Other: Quality of life assessment Other: Laboratory Biomarker Analysis |
PRIMARY OBJECTIVES:
I. Define acute toxicity, subsequent malignant neoplasm (SMN) risk and visual outcomes in retinoblastoma (RB) survivors and compare patient centered psychosocial and neurocognitive and physical outcomes in survivors with normative data and sibling controls.
II. Create the first Clinically-Annotated Patient Tissues to Analyze Gene INteractions to assess biologic correlates of disease and facilitate future research: The RIVERBOAT-CAPTAIN biorepository, including germline deoxyribonucleic acid (DNA) and tumor tissue from patients, with detailed patient, disease and treatment-related information.
III. Using the RIVERBOAT-CAPTAIN clinically-annotated biorepository, determine the interplay between specific RB1 mutation type and the role of additional modifier genes in determining those tumor phenotypes that drive treatment decisions.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
RETROSPECTIVE COHORT: Patients treated between 2008-2018 undergo collection of saliva samples at >= 6 months after treatment, and undergo vision assessment at >= 6 months after treatment and again 1 year later if necessary. Previously collected tissue samples at the time of surgery are also obtained. Patients also complete questionnaires at >= 6 months after treatment and again 2 years later.
PROSPECTIVE COHORT: Patients treated between 2018-2023 undergo collection of saliva samples at the time of enrollment and at 6 months after treatment. Patients also undergo vision assessment at the time of enrollment, at 6 months, and 18 months after completion of treatment. Patients also complete questionnaires at 6 months and again 2 years later, as well as undergo collection of tissue samples at the time of surgery. Immediate family members with history of RB or RB1 gene mutation also undergo collection saliva samples.
Study Type : | Observational |
Estimated Enrollment : | 900 participants |
Observational Model: | Case-Control |
Time Perspective: | Other |
Official Title: | Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT) |
Actual Study Start Date : | January 24, 2019 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | January 2026 |
Group/Cohort | Intervention/treatment |
---|---|
Retrospective(biospecimens, vision assessment, questionnaires) |
Procedure: Biospecimen collection
Collection of tissue and saliva samples
Other: Vision assessment Undergo vision assessment
Other: Questionnaire administration Complete questionnaires
Other: Quality of life assessment Complete questionnaires
Other: Laboratory Biomarker Analysis Correlative studies
|
Prospective (biospecimens, vision assessment, questionnaires) |
Procedure: Biospecimen collection
Collection of tissue and saliva samples
Other: Vision assessment Undergo vision assessment
Other: Questionnaire administration Complete questionnaires
Other: Quality of life assessment Complete questionnaires
Other: Laboratory Biomarker Analysis Correlative studies
|
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Retrospective group patients must be ≥ 6 months post end of treatment at study entry
Contact: Vanderbilt-Ingram Service for Timely Access | 800-811-8480 | cip@vanderbilt.edu |
United States, Illinois | |
Lurie Children's Hospital | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Monica Newmark mnewmark@luriechildrens.org | |
Principal Investigator: Joanna Weinstein, MD | |
University of Illinois, Chicago | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Kristen kitsch kitsc@uic.edu | |
Principal Investigator: Mary Lou Schmidt, MD | |
United States, Minnesota | |
University of Minnesoa | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Kendra Pallin palli007@umn.edu | |
Principal Investigator: Joseph Neglia, MD | |
United States, Missouri | |
Washington School of Medicine at St. Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Kara Sauerburger sauerburgerk@wustl.edu | |
Principal Investigator: Robert Hayashi, MD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Amanda Pfeiffer amanda.pfeiffer@cchmc.org | |
Principal Investigator: Rajaram Nagarajan, MD | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Stephen Markham markhams@chop.edu | |
Principal Investigator: Amish Shah, MD, PhD | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480 | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Theresa Honey TAHoney@mdanderson.org | |
Principal Investigator: Anna Herzog, MD | |
Texas Childeren's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Najeeba Ali nmali@texaschildrens.org | |
Principal Investigator: Murali Chintagumpala, MD | |
United States, Wisconsin | |
Children's Hospital of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Veronica Seher vseher@mcw.edu | |
Principal Investigator: Cindy Schwartz, MD | |
Canada | |
The Hosptial for Sick Children | Recruiting |
Toronto, Canada | |
Contact: Roxanna Noronha roxanna.noronha@sickkids.ca | |
Principal Investigator: Helen Dimaras, MD |
Principal Investigator: | Debra Friedman, MD | Vanderbilt Medical Center |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | March 15, 2019 | ||||
First Posted Date | May 1, 2019 | ||||
Last Update Posted Date | April 21, 2021 | ||||
Actual Study Start Date | January 24, 2019 | ||||
Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Studying Health Outcomes After Treatment in Patients With Retinoblastoma | ||||
Official Title | Research Into Visual Endpoints and RB Health Outcomes After Treatment (RIVERBOAT) | ||||
Brief Summary | This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering health information over time from patients and family members through vision assessments, samples of tissue and saliva, and questionnaires may help doctors learn more about what causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma, and find out which therapies may be the best for treating retinoblastoma | ||||
Detailed Description |
PRIMARY OBJECTIVES: I. Define acute toxicity, subsequent malignant neoplasm (SMN) risk and visual outcomes in retinoblastoma (RB) survivors and compare patient centered psychosocial and neurocognitive and physical outcomes in survivors with normative data and sibling controls. II. Create the first Clinically-Annotated Patient Tissues to Analyze Gene INteractions to assess biologic correlates of disease and facilitate future research: The RIVERBOAT-CAPTAIN biorepository, including germline deoxyribonucleic acid (DNA) and tumor tissue from patients, with detailed patient, disease and treatment-related information. III. Using the RIVERBOAT-CAPTAIN clinically-annotated biorepository, determine the interplay between specific RB1 mutation type and the role of additional modifier genes in determining those tumor phenotypes that drive treatment decisions. OUTLINE: Patients are assigned to 1 of 2 cohorts. RETROSPECTIVE COHORT: Patients treated between 2008-2018 undergo collection of saliva samples at >= 6 months after treatment, and undergo vision assessment at >= 6 months after treatment and again 1 year later if necessary. Previously collected tissue samples at the time of surgery are also obtained. Patients also complete questionnaires at >= 6 months after treatment and again 2 years later. PROSPECTIVE COHORT: Patients treated between 2018-2023 undergo collection of saliva samples at the time of enrollment and at 6 months after treatment. Patients also undergo vision assessment at the time of enrollment, at 6 months, and 18 months after completion of treatment. Patients also complete questionnaires at 6 months and again 2 years later, as well as undergo collection of tissue samples at the time of surgery. Immediate family members with history of RB or RB1 gene mutation also undergo collection saliva samples. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Other |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
Tissue, saliva
|
||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Retrospective patients (those treated between 2008 and 2018) identified by each site at the start of the study period and prospective patients (those treated between 2018 and 2023) identified at the time of diagnosis by each site during the study period with unilateral or bilateral intraocular retinoblastoma | ||||
Condition |
|
||||
Intervention |
|
||||
Study Groups/Cohorts |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
900 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | January 2026 | ||||
Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
|
||||
Sex/Gender |
|
||||
Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
|
||||
Listed Location Countries | Canada, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03932786 | ||||
Other Study ID Numbers | VICC PED 1878 NCI-2019-00635 ( Registry Identifier: NCI, Clinical Trials Reporting Program ) 1R01CA225005-01A1 ( U.S. NIH Grant/Contract ) |
||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Debra Friedman, Vanderbilt-Ingram Cancer Center | ||||
Study Sponsor | Vanderbilt-Ingram Cancer Center | ||||
Collaborators | National Cancer Institute (NCI) | ||||
Investigators |
|
||||
PRS Account | Vanderbilt-Ingram Cancer Center | ||||
Verification Date | April 2021 |