Clinical trial NCT04706845: Understanding the Burden of ACC Through the Eyes of Patients
Official title: Understanding the Burden of ACC Through the Eyes of Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoid Cystic Carcinoma
Lead sponsor: Ayala Pharmaceuticals, Inc,
Sponsor class: INDUSTRY
Collaborators: name: Adenoid Cystic Carcinoma Research Foundation
name: Memorial Sloan Kettering Cancer Center
name: Hadassah Medical Organization
name: Engage Health Inc.
First posted: 2021-01-13
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within the United States or Israel, patients who have been diagnosed with Adenoid Cystic Carcinoma (ACC)

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

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

Primary outcomes:
measure: Key burdens related to the disease or treatments
timeFrame: Q4-2021
measure: Life impacts of those burdens for patient/family
timeFrame: Q4-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Eagan
country: United States
facility: Engage Health
state: Minnesota
Study officials:
References: