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

NCT05703243 | Unknown

• 1 other identifier: DINOSAur II
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Solid Tumors; Stage IV Solid Tumors

Outcome Measures

Primary Outcomes (1)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30)

  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.

  2 years

Secondary Outcomes (1)

• Compare the proportion of enrolling in clinical trials

  2 years

Study Arms (2)

Active

Newly diagnosed cancer patients.

Diagnostic Test: Comprehensive liquid molecular panel test; Other: EORTC QLQ-30

Control

Historically diagnosed cancer patients.

Interventions

Comprehensive liquid molecular panel test DIAGNOSTIC_TEST

Lab test

Active

EORTC QLQ-30 OTHER

Quality of life questionnaire

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly diagnosed cancer patients at the pathology level

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glendale Adventist Medical Center d/b/a Adventist Health Glendale: lead
• Guardant Health, Inc.: collaborator

Study Sites (1)

Adventist Health Glendale

Glendale, California, 91206, United States

RECRUITING

Study Officials

• Mihran H Shirinian, MD

  Glendale Adventist Medical Center dba Adventist Health Glendale

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihran H Shirinian, MD

CONTACT

818-543-7574; mshirin@aol.com

Lily Villalobos, MHA

CONTACT

818-409-8009; villall3@ah.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 27, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)