MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

NCT ID: NCT05189171

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2024-03-18

Brief Summary

The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and completing a drug screen against patient-derived MOS using standard of care drugs used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab) in ≤ 14 days.

Conditions

Colorectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Metastatic colorectal cancer

Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

MicroOrganoSphere (MOS) drug screen

Intervention Type: DEVICE

Patient-derived models of cancer, called MOS, will be generated from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and a drug screen using standard-of-care drugs used will be completed (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab). Subjects will receive standard-of-care therapy for CRC dictated by their treating physicians.

Interventions

MicroOrganoSphere (MOS) drug screen

Patient-derived models of cancer, called MOS, will be generated from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and a drug screen using standard-of-care drugs used will be completed (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab). Subjects will receive standard-of-care therapy for CRC dictated by their treating physicians.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
• Male or female age 18 or older when written informed consent is obtained.
• Study candidate is willing and able to comply with all protocol-required procedures and assessments.
• Study candidate either

1. is scheduled for or plans to be scheduled for a biopsy of the liver OR

2. has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

Exclusion Criteria

• If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.).
• Study candidate is participating (or intends to participate) in another clinical study AND either:

1. is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR

2. that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm).

• Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xilis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Official

Role: STUDY_DIRECTOR

Xilis, Inc.

Locations

Mayo Clinic

Scottsdale, Arizona, United States

MedStar Washington Hospital

Washington D.C., District of Columbia, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

The University of Tennessee Medical Center

Knoxville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Inland Imaging

Spokane, Washington, United States

Countries

United States

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Other Identifiers

146057.60

Identifier Type: -

Identifier Source: org_study_id