MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Device: MicroOrganoSphere (MOS) drug screen

• Registration Number: NCT05189171
• Lead Sponsor: Xilis, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-12
• Study Start: 2022-10-25
• Primary Completion: 2023-11-03
• Study Completion: 2024-03-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Key

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic colorectal cancer	MicroOrganoSphere (MOS) drug screen	Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.

Primary Outcome Measures

Name	Time	Method
MOS generation	<14 Days from start of MOS generation	Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis

Trial Locations

Locations (5)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

MedStar Washington Hospital; 🇺🇸 Washington, District of Columbia, United States

Inland Imaging; 🇺🇸 Spokane, Washington, United States

The University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States