CancerNCT07226180
Development and Application of Patient-Derived Models of Cancer
An observational study of Cancer, run by Certis Oncology Solutions, Inc at 3 sites in United States.
Trial summary
The purpose of this observational study is to evaluate the clinical utility of investigational patient-derived cancer models, to assess the performance of biomarker-based therapeutic predictions in the patient-derived models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients of Hoag Memorial Hospital Presbyterian, Hoag Hospital Irvine, and Hoag Health Center Newport Beach
Who may be able to join
- Solid tumor patients stage 2-4.
- Cancer patients who have been previously treated or shown resistance or refraction to standard-of-care therapies and where the implicated tissue has not been irradiated in the ten (10) weeks prior to excision.
- Patients with tumors are amenable to biopsy or surgery for fresh tissue and blood procurement as part of routine clinical care
- Patients must be referred by a healthcare professional
- Willingness for tissue samples used in future research
- Signed informed consent
- Willingness to share diagnosis, available genetic/molecular profiling data, treatment history, and treatment outcome monitoring
Who cannot join
- Failure to provide informed consent
- Inaccessible tumors for biopsy or unavailability of tumor tissue for research purposes
- Subjects under the age of 18
- Subjects with cognitive impairment
- Pregnant subjects
- Contraindications to undergoing a biopsy procedure
- No prior treatments, naive
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Hoag Hospital Irvine
Irvine, California, 92618
Hoag Health Center Newport Beach
Newport Beach, California, 92663
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: Beyond Genomics Functional Precision Oncology Research Study
The purpose of this observational study is to evaluate the clinical utility of investigational patient-derived cancer models, to assess the performance of biomarker-based therapeutic predictions in the patient-derived models.
Each participant in the observational study will have a piece of cancer removed as part of routine, physician direct care and grown in laboratory mice, where multiple anti-cancer drugs can be tested on it simultaneously. Additional data will be provided to the oncologist; interpretation of the results and any clinical actions are at the sole discretion of the oncologist.
Read the detailed description
Participants are planned to undergo a procedure, such as a biopsy or surgery, as part of routine care. After enough tissue to complete all routine tests required for the participants' care are provided, if the participant decides to take part in this study, any leftover biopsy or surgically obtained tissue/fluid, and blood specimens will be sent to the Certis laboratory for testing. It will be required to provide details regarding the participants' biopsy, such as the date, location, and contact information for the study team performing the procedure. The oncologist will assist with this, and once confirmed, a kit will be sent to the location of the procedure to transport the specimen back to the Certis laboratory in San Diego, California.
The process of developing an individualized PDX (Patient Derived Xenograft) model is a 2-step process. The first is Initiation, where the biopsy is surgically implanted into 2-5 specialized research mice, depending on the size and quality of biopsy received, to allow it to grow. This identifies if the participants' tumor is suitable for growing in mice, as well as generating enough tumor material to conduct large studies on. This takes approximately 3-4 months.
The next step is Pharmacology. Here, selected tumors from the initial 5 mice are removed, dissected, and implanted into a larger number of mice, approximately 50. These mice are then divided into groups of 5, and each group is given a different anti-cancer therapy. Certis will work closely with the oncologist to select the therapies to test. The mice are treated for a period of 4 weeks, and the tumors are measured weekly to determine which therapies are better at treating the participants tumor in mice. The oncologist will be updated upon pre-specified study milestones.
- Conditions
- Cancer
- Keywords
- solid tumor, PDX, patient-derived cancer models
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PDX Tumor Growth
The primary outcome of this study is the successful engraftment of patient-derived xenograft (PDX) tumors in the study animals. Engraftment success will be assessed by quantifying tumor growth using caliper measurements and/or magnetic resonance imaging (MRI). Successful engraftment will be defined as measurable and sustained tumor growth consistent with the characteristics of the original patient tumor.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start11 Dec 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Certis Oncology Solutions, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226180
- Sponsor's protocol ID
- COS-IRB-001A - 220-23-CA
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 18 Mar 2026
- 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Genomics Functional Precision Oncology Research Study
- ClinicalTrials.gov ID
- NCT07226180
- Acronym / sponsor ID
- COS-IRB-001A - 220-23-CA
- Conditions
- Cancer
- Keywords
- solid tumor, PDX, patient-derived cancer models
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Certis Oncology Solutions, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 10 Nov 2025 (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.
The purpose of this observational study is to evaluate the clinical utility of investigational patient-derived cancer models, to assess the performance of biomarker-based therapeutic predictions in the patient-derived models.
Each participant in the observational study will have a piece of cancer removed as part of routine, physician direct care and grown in laboratory mice, where multiple anti-cancer drugs can be tested on it simultaneously. Additional data will be provided to the oncologist; interpretation of the results and any clinical actions are at the sole discretion of the oncologist.
Detailed description
Participants are planned to undergo a procedure, such as a biopsy or surgery, as part of routine care. After enough tissue to complete all routine tests required for the participants' care are provided, if the participant decides to take part in this study, any leftover biopsy or surgically obtained tissue/fluid, and blood specimens will be sent to the Certis laboratory for testing. It will be required to provide details regarding the participants' biopsy, such as the date, location, and contact information for the study team performing the procedure. The oncologist will assist with this, and once confirmed, a kit will be sent to the location of the procedure to transport the specimen back to the Certis laboratory in San Diego, California.
The process of developing an individualized PDX (Patient Derived Xenograft) model is a 2-step process. The first is Initiation, where the biopsy is surgically implanted into 2-5 specialized research mice, depending on the size and quality of biopsy received, to allow it to grow. This identifies if the participants' tumor is suitable for growing in mice, as well as generating enough tumor material to conduct large studies on. This takes approximately 3-4 months.
The next step is Pharmacology. Here, selected tumors from the initial 5 mice are removed, dissected, and implanted into a larger number of mice, approximately 50. These mice are then divided into groups of 5, and each group is given a different anti-cancer therapy. Certis will work closely with the oncologist to select the therapies to test. The mice are treated for a period of 4 weeks, and the tumors are measured weekly to determine which therapies are better at treating the participants tumor in mice. The oncologist will be updated upon pre-specified study milestones.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Hoag Memorial Hospital Presbyterian, Hoag Hospital Irvine, and Hoag Health Center Newport Beach
Key inclusion criteria (7 listed)
- Solid tumor patients stage 2-4.
- Cancer patients who have been previously treated or shown resistance or refraction to standard-of-care therapies and where the implicated tissue has not been irradiated in the ten (10) weeks prior to excision.
- Patients with tumors are amenable to biopsy or surgery for fresh tissue and blood procurement as part of routine clinical care
- Patients must be referred by a healthcare professional
- Willingness for tissue samples used in future research
Key exclusion criteria (7 listed)
- Failure to provide informed consent
- Inaccessible tumors for biopsy or unavailability of tumor tissue for research purposes
- Subjects under the age of 18
- Subjects with cognitive impairment
- Pregnant subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PDX Tumor Growth
Time frame: 180 days
The primary outcome of this study is the successful engraftment of patient-derived xenograft (PDX) tumors in the study animals. Engraftment success will be assessed by quantifying tumor growth using caliper measurements and/or magnetic resonance imaging (MRI). Successful engraftment will be defined as measurable and sustained tumor growth consistent with the characteristics of the original patient tumor.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Certis Oncology Solutions, Inc at 3 sites 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 7 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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDX Tumor Growth (time frame: 180 days). 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 18 Mar 2026.