Understanding the Burden of ACC Through the Eyes of Patients

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.

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

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