MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

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

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
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.

Treatment and study plan

MicroOrganoSphere (MOS) drug screen

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.

Primary outcomes

MOS generation

Time frame: <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

Sponsors and collaborators

Lead sponsor

Xilis, Inc.

Industry

Registry information

Official study title

MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)

Acronym: MODEL-CRC

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Jan 12, 2022
Registry last updated: Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed