Understanding the Burden of ACC Through the Eyes of Patients

Ayala Pharmaceuticals

Status: Completed

Conditions: Adenoid Cystic Carcinoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04706845

AL Patient Burden 01

Details and patient eligibility

About

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)

Full 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

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 5 patient groups

1

Description:

No evident disease

2

Description:

Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation

3

Description:

Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type

4

Description:

Progressive Disease: Tumors bearing NOTCH Mutation

5

Description:

Progressive Disease: Tumors bearing Notch Wild Type