Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06078527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.
Detailed Description:
PRIMARY OBJECTIVES:
I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).
SECONDARY OBJECTIVES:
I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.
III. To assess patient reported outcomes (PROs).
EXPLORATORY OBJECTIVES:
I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:
* modified barium swallow (MBS) study kinematics;
* MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
* MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
* Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
* Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).
OUTLINE:
Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).
I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).
SECONDARY OBJECTIVES:
I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.
III. To assess patient reported outcomes (PROs).
EXPLORATORY OBJECTIVES:
I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to:
* modified barium swallow (MBS) study kinematics;
* MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST);
* MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs);
* Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES)
* Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES).
OUTLINE:
Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-10667 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |