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| Name | Class |
|---|---|
| Cook MyoSite | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tongue Dysphagia Oropharyngeal Cancer | Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. | Other | Participants are followed observationally to collect long-term safety and effectiveness data after prior receipt of iltamiocel in the separate Revive clinical trial; no intervention is administered as part of this registry. Long-term safety outcomes and efficacy will be separated in analysis & reporting |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events | 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. | From baseline through 5 years of follow-up, assessed annually |
| Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI) | Anterior tongue pressure measured using the Iowa Oral Performance Instrument (IOPI). Range 0-100 kPa, where a lower number indicates less strength. | Baseline and annually up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10) | Patient-reported dysphagia symptoms assessed using the Eating Assessment Tool (EAT-10) total score. Eating Assessment Tool (EAT-10), range 0-40, where higher scores indicate worse dysphagia symptoms. Survey consisting of 10 questions (see table below), each score on a scale of 0-4, with 0= no problem, 4= severe problem. 922 Belafsky et al. Eating Assessment Tool TABLE 3. EATING ASSESSMENT TOOL (EAT-10) Circle the appropriate response. To what extent are the following scenarios problematic for you?
|
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Inclusion Criteria:
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:
Exclusion Criteria:
The following criteria will exclude participants from participation:
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Participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study will be considered for enrollment. Eligibility according to inclusion and exclusion criteria is based on the participant's status at time of enrollment (Informed Consent Form (ICF) completion). All eligible participants consenting to study participation are expected to complete follow-up visits on a yearly basis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Randev Sandhu, BS | Contact | 916-734-2863 | rssandhu@health.ucdavis.edu | |
| Johnathon Anderson, PhD | Contact | 916-734-2801 | joanderson@health.ucdavis.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Belafsky, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Baseline and annually up to 5 years |
| Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ) | Patient-reported smell and taste function assessed using the ChemoSensory Smell and Taste Questionnaire (CSQ). Consists of 8 items divided into two subscales: 4 items for smell and 4 items for taste and each with a range of 1 to 5, where 1 is never, 2 is Rarely, 3 is Sometimes, 4 is Frequently and 5 is Always. Each scale ranges from 4 to 20, where higher scores indicate better chemosensory function. | Baseline and annually up to 5 years |
| Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS) | Functional oral intake assessed using the Functional Oral Intake Scale (FOIS). It is a 7-level ordinal scale used to document the functional level of oral food and liquid intake in patients with dysphagia. It ranges from Level 1 (no oral intake/tube-dependent) to Level 7 (full oral intake without restrictions), where the higher the score the less oral intake restrictions. | Baseline and annually up to 5 years |
| Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI) | Dysphagia-related quality of life assessed using the MD Anderson Dysphagia Inventory (MDADI). It is a 20-item questionnaire that measures swallowing-related quality of life, scoring from 20 to 100. Higher scores indicate better functioning, with 20 representing the lowest and 100 the highest. | Baseline and annually up to 5 years |
| UC SanFrancisco Medical Center | San Francisco | California | 94115 | United States |
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| D010038 | Otorhinolaryngologic Diseases |