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

March 1, 2023 updated by: Mihran Shirinian, Glendale Adventist Medical Center d/b/a Adventist Health Glendale

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

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.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

572

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mihran H Shirinian, MD
  • Phone Number: 818-543-7574
  • Email: mshirin@aol.com

Study Contact Backup

  • Name: Lily Villalobos, MHA
  • Phone Number: 818-409-8009
  • Email: villall3@ah.org

Study Locations

    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Adventist Health Glendale
        • Principal Investigator:
          • Mihran Shirinian, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newly diagnosed cancer patients at the pathology level

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active
Newly diagnosed cancer patients.
Quality of life questionnaire
Lab test
Control
Historically diagnosed cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30)
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the proportion of enrolling in clinical trials
Time Frame: 2 years
To compare the proportion of enrolling in clinical trials between cancers patients who received the CLMT versus cancer patients with no CLMT.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Mihran H Shirinian, MD, Glendale Adventist Medical Center dba Adventist Health Glendale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DINOSAur II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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