Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting ("DINOSAur II")

Recruiting

• Conditions: Stage IV Solid Tumors; Stage III Solid Tumors
• Interventions: Diagnostic Test: Comprehensive liquid molecular panel test; Other: EORTC QLQ-30

• Registration Number: NCT05703243
• Lead Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale

Brief Summary

To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive l i q u i d molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-27
• Study Start: 2023-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-03
• Primary Completion: 2024-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 572

Inclusion Criteria

• Patients who have given informed consent in accordance with the methods and procedures of this study
• Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care
• Patients who have not received treatment related to his/her cancer
• Patients who are willing to sign a release of medical records to the research team
• Male and female patients ≥18 years of age
• Patients under oncology care
• Sufficient clinical status for collection of blood sample within usual care

Exclusion Criteria

• Patients considered minors in the jurisdiction where the protocol is conducted
• Patients who are prisoners and pregnant women
• Patients who cannot provide consent and did not sign a power of attorney

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active	Comprehensive liquid molecular panel test	Newly diagnosed cancer patients.
Active	EORTC QLQ-30	Newly diagnosed cancer patients.

Primary Outcome Measures

Name	Time	Method
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30)	2 years	The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. The scaling of items is 1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). The higher the score the better the quality of life.

Secondary Outcome Measures

Name	Time	Method
Compare the proportion of enrolling in clinical trials	2 years	To compare the proportion of enrolling in clinical trials between cancers patients who received the CLMT versus cancer patients with no CLMT.

Trial Locations

Locations (1)

Adventist Health Glendale; 🇺🇸 Glendale, California, United States