- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05703243
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
Status
Recruiting
Conditions
Intervention / Treatment
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:
- Mihran Shirinian, M.D.
- Phone Number: 818-543-7574
- Email: mshirin@aol.com
-
-
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.
Clinical Trials on Stage III Solid Tumors
-
Glendale Adventist Medical Center d/b/a Adventist...Caris Life SciencesRecruitingStage III Solid Tumors | Stage IV Solid TumorsUnited States
-
Memorial Sloan Kettering Cancer CenterTesaro, Inc.RecruitingSolid Tumor | Solid Tumor, Adult | Rectal Adenocarcinoma | Clinical Stage: Stage II (T3-4, N-) | Stage III (Any T, N+)United States
-
Janssen Research & Development, LLCRecruitingAdvanced Stage Solid TumorsSpain
-
Leap Therapeutics, Inc.Cancer Research Institute, New York CityCompletedUnresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor MalignanciesUnited States
-
Tianjin Hemay Oncology Pharmaceutical Co., LtdRecruitingPatients With Advanced Stage Solid TumorsChina
-
Cure Cancer Worldwide CorporationUnknownSurvival | Stage IV Cancer (Solid Tumors Only)China
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Recurrent Melanoma | Stage IV Melanoma | Stage III MelanomaUnited States
-
MedPacto, Inc.National OncoVentureCompletedAdvanced Stage Solid TumorsUnited States
-
National Cancer Institute (NCI)WithdrawnMetastatic Melanoma | Stage III Cutaneous Melanoma AJCC v7 | Stage IV Cutaneous Melanoma AJCC v6 and v7 | Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Stage IIIC Cutaneous Melanoma AJCC v7 | Estrogen Receptor Negative | HER2/Neu Negative | Progesterone Receptor Negative | Triple-Negative... and other conditions
-
Oxford University Hospitals NHS TrustUniversity of Oxford; Barts & The London NHS Trust; Ninewells HospitalCompletedMelanoma Stage III | Melanoma, Stage II | Melanoma, Stage IUnited Kingdom
Clinical Trials on EORTC QLQ-30
-
Chulabhorn Cancer CenterCompleted
-
Glendale Adventist Medical Center d/b/a Adventist...Caris Life SciencesRecruitingStage III Solid Tumors | Stage IV Solid TumorsUnited States
-
Ludwig-Maximilians - University of MunichRecruitingQuality of Life | Chemoradiation | Anal CancerGermany
-
Ludwig-Maximilians - University of MunichRecruitingQuality of Life | Chemoradiation | Rectal Cancer | Radiation TherapyGermany
-
Washington University School of MedicineTerminatedHepatocellular Carcinoma | Pancreatic Cancer | Pancreas Cancer | Cancer of the PancreasUnited States
-
The University of Texas Health Science Center at...Recruiting
-
Memorial Sloan Kettering Cancer CenterCompletedAdvanced Stage Head and Neck CancerUnited States
-
Ludwig-Maximilians - University of MunichRecruitingQuality of Life | Esophageal Cancer | ChemoradiationGermany
-
University Hospital, AntwerpRecruiting
-
National Cancer Institute, NaplesNot yet recruiting