NCT05692466

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
572

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

December 21, 2021

Last Update Submit

March 1, 2023

Conditions

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.

    2 years

Secondary Outcomes (1)

  • Compare the proportion of patients enrolling in clinical trials

    2 years

Study Arms (2)

Active

Newly diagnosed cancer patients.

Diagnostic Test: Comprehensive molecular panel testOther: EORTC QLQ-30

Control

Historically diagnosed cancer patients.

Interventions

Lab test

Active

Quality of life questionnaire

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 of a participating site
  • Sufficient clinical status for collection of biospecimen samples within usual care
  • Patients who have insurance coverage for CMT

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adventist Health Glendale

Glendale, California, 91206, United States

RECRUITING

Central Study Contacts

Mihran H Shirinian, MD

CONTACT

Lily Villalobos, MHA

CONTACT

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

December 21, 2021

First Posted

January 20, 2023

Study Start

February 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2025

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations