Stage III Solid TumorsDINOSAur IINCT05703243
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting ("DINOSAur II")
An observational study of Stage III Solid Tumors and Stage IV Solid Tumors, run by Glendale Adventist Medical Center d/b/a Adventist Health Glendale at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Solid Tumors, Stage IV Solid Tumors
- What is being tested?
- Comprehensive liquid molecular panel test and EORTC QLQ-30
- How many people
- 572 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Jan 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed cancer patients at the pathology level
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Adventist Health Glendale
Glendale, California, 91206
Mihran Shirinian, M.D., 818-543-7574, mshirin@aol.com
Mihran Shirinian, M.D.
About this study
Official title: 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.
- Conditions
- Stage III Solid Tumors, Stage IV Solid Tumors
- Being tested
- Comprehensive liquid molecular panel test, EORTC QLQ-30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive liquid molecular panel testDiagnostic test
Lab test
EORTC QLQ-30Other
Quality of life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Active | Newly diagnosed cancer patients. Receives: Diagnostic Test: Comprehensive liquid molecular panel test; Other: EORTC QLQ-30 | |
| Control | Historically diagnosed cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Compare the proportion of enrolling in clinical trials
To compare the proportion of enrolling in clinical trials between cancers patients who received the CLMT versus cancer patients with no CLMT.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 572 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Glendale Adventist Medical Center d/b/a Adventist Health Glendale
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health, Inc.
- Responsible party
- Principal investigator, Mihran Shirinian, Glendale Adventist Medical Center d/b/a Adventist Health Glendale
- Investigators
- Mihran H Shirinian, MD, Principal investigator, Glendale Adventist Medical Center dba Adventist Health Glendale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703243
- Sponsor's protocol ID
- DINOSAur II
- Acronym
- DINOSAur II
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting. ("DINOSAur II")
- ClinicalTrials.gov ID
- NCT05703243
- Acronym / sponsor ID
- DINOSAur II / DINOSAur II
- Conditions
- Stage III Solid Tumors, Stage IV Solid Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Glendale Adventist Medical Center d/b/a Adventist Health GlendaleUniversity, hospital or other
- Collaborators
- Guardant Health, Inc.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | Diagnostic Test: Comprehensive liquid molecular panel test, Other: EORTC QLQ-30Newly diagnosed cancer patients. |
| Control | – | –Historically diagnosed cancer patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed cancer patients at the pathology level
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive liquid molecular panel testLab test | Diagnostic test | Active |
| EORTC QLQ-30Quality of life questionnaire | Other | Active |
Primary outcome
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.
1 secondary outcome
Compare the proportion of enrolling in clinical trials
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihran H Shirinian, MD principal investigator
Glendale Adventist Medical Center dba Adventist Health Glendale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Solid Tumors and Stage IV Solid Tumors, run by Glendale Adventist Medical Center d/b/a Adventist Health Glendale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihran H Shirinian, MD (818-543-7574, mshirin@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023; AzTrials last refreshed its copy on 5 Nov 2026.