Understanding the Burden of ACC Through the Eyes of Patients

NCT04706845 | Completed

• 1 other identifier: AL Patient Burden 01
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor. Primary Objectives:

• To identify the specific burdens faced by patients with ACC
• To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (2)

• Key burdens related to the disease or treatments

  Q4-2021

• Life impacts of those burdens for patient/family

  Q4-2021

Study Arms (5)

1

No evident disease

2

Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation

3

Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type

4

Progressive Disease: Tumors bearing NOTCH Mutation

5

Progressive Disease: Tumors bearing Notch Wild Type

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Within the United States or Israel, patients who have been diagnosed with Adenoid Cystic Carcinoma (ACC)

You may qualify if:

• Participant must be a person diagnosed with ACC who is 18 years or older
• For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor
• Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.
• Able to read, write and understand English, Hebrew, Arabic, or Russian
• Able to grant informed consent
• Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)

Sponsors & Collaborators

• Ayala Pharmaceuticals, Inc,: lead
• Adenoid Cystic Carcinoma Research Foundation: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Hadassah Medical Organization: collaborator
• Engage Health Inc.: collaborator

Study Sites (1)

Engage Health

Eagan, Minnesota, 55121, United States

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: January 11, 2021
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)