Understanding the Burden of ACC Through the Eyes of Patients

NCT ID: NCT04706845

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-11

Study Completion Date

2023-08-16

Brief Summary

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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

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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

Conditions

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Adenoid Cystic Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No evident disease

No interventions assigned to this group

2

Metastatic Disease; Watchful Waiting: Tumors bearing NOTCH Mutation

No interventions assigned to this group

3

Metastatic Disease; Watchful Waiting: Tumors bearing Notch Wild Type

No interventions assigned to this group

4

Progressive Disease: Tumors bearing NOTCH Mutation

No interventions assigned to this group

5

Progressive Disease: Tumors bearing Notch Wild Type

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adenoid Cystic Carcinoma Research Foundation

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Engage Health Inc.

INDUSTRY

Sponsor Role collaborator

Ayala Pharmaceuticals, Inc,

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Engage Health

Eagan, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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AL Patient Burden 01

Identifier Type: -

Identifier Source: org_study_id

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