Development and Application of Patient-Derived Models of Cancer

NCT07226180 | Enrolling By Invitation

• 1 other identifier: COS-IRB-001A - 220-23-CA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Cancer

Keywords

solid tumor; PDX; patient-derived cancer models

Outcome Measures

Primary Outcomes (1)

• 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.

  180 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Hoag Memorial Hospital Presbyterian, Hoag Hospital Irvine, and Hoag Health Center Newport Beach

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Certis Oncology Solutions, Inc: lead

Study Sites (3)

Hoag Hospital Irvine

Irvine, California, 92618, United States

Location

Hoag Health Center Newport Beach

Newport Beach, California, 92663, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsy or surgically obtained tumor tissue/fluid, blood specimens

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 10, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)