Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of REVIVE Clinical Study in Patients With Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events
研究概览
简要总结
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.
详细描述
This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person. The objectives of this study are to:
- Evaluate the long-term safety of iltamiocel
- Evaluate the long-term effectiveness of iltamiocel treatment as demonstrated through anterior tongue strength and patient reported outcomes (PROs) related to tongue dysphagia (TD) symptoms, quality of life (QOL), and overall satisfaction.
The duration of participants' participation in this registry will extend to 5 years after enrollment. This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have received iltamiocel as part of participation in the REVIVE clinical study for males and females with tongue dysphagia (TD) are eligible, provided the following criteria are fulfilled:
- •Has completed the Month 24 visit in the REVIVE study.
- •Has received iltamiocel as part of the blinded portion of the REVIVE study.
- •Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
排除标准
- •The following criteria will exclude participants from participation:
- •Has received placebo as part of the blinded portion of the REVIVE study.
- •Unable or unwilling to provide informed consent.
- •Not available for, or willing to comply with the follow-up evaluations as required by the protocol.
研究组 & 干预措施
Tongue Dysphagia Oropharyngeal Cancer
Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study
干预措施: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. (Other)
结局指标
主要结局
Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events
时间窗: From baseline through 5 years of follow-up, assessed annually
Iltamiocel-related adverse events (AEs) and iltamiocel-related serious adverse events (SAEs) assessed by the investigator. Long-term safety outcomes and efficacy outcomes will be separated in analysis and reporting.
Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI)
时间窗: Baseline and annually up to 5 years
Anterior tongue pressure measured using the Iowa Oral Performance Instrument (IOPI). Range 0-100 kPa, where a lower number indicates less strength.
次要结局
- Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10)(Baseline and annually up to 5 years)
- Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ)(Baseline and annually up to 5 years)
- Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS)(Baseline and annually up to 5 years)
- Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI)(Baseline and annually up to 5 years)
研究者
Peter Belafsky, MD
Director, Center for Voice & Swallowing Professor, Department of Otolaryngology
University of California, Davis