Brief Title
Understanding the Burden of ACC Through the Eyes of Patients
Official Title
Understanding the Burden of ACC Through the Eyes of Patients
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)
Detailed Description
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) Secondary Objectives: - To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma) - To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to: - Rate of disease progression - Location of Metastases
Study Type
Observational
Primary Outcome
Key burdens related to the disease or treatments
Condition
Adenoid Cystic Carcinoma
Study Arms / Comparison Groups
1
Description: No evident disease
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
60
Start Date
January 11, 2021
Completion Date
March 31, 2022
Primary Completion Date
December 31, 2021
Eligibility Criteria
Inclusion Criteria: 1. Participant must be a person diagnosed with ACC who is 18 years or older 2. For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor 3. 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. 4. Able to read, write and understand English, Hebrew, Arabic, or Russian 5. Able to grant informed consent 6. Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary) Exclusion Criteria: 1. Inability to meet any of the inclusion criteria
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, (651)994-0510, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04706845
Organization ID
AL Patient Burden 01
Responsible Party
Sponsor
Study Sponsor
Ayala Pharmaceuticals, Inc,
Collaborators
Adenoid Cystic Carcinoma Research Foundation (ACCRF)
Study Sponsor
, ,
Verification Date
January 2021