MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer (MODEL-CRC)

January 17, 2024 updated by: Xilis, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the feasibility of creating patient derived models of cancer (i.e., MOS) from patients with colorectal cancer liver metastasis. The investigators of this study focus on a precision medicine strategy for patients with CRC liver metastasis.

Participating subjects will undergo biopsy of patient's liver lesion and the diagnosis of CRC liver metastasis will be verified by pathology. Patients will be treated with standard of care therapy determined by the treating physician. As part of standard of care therapy, patients will undergo lab work including CEA (carcinoembryonic antigen) and CT of the chest, abdomen and pelvis for staging and measurement of tumor size every two months.

Up to 250 patients will be enrolled to the study. Enrolled subjects are defined as subjects who give informed consent. Screen failures are defined as subjects who give informed consent and do not meet eligibility criteria. Accrued subjects are defined as subjects who give informed consent and meet eligibility criteria. Evaluable subjects are defined as those who accrue, receive the study biopsy and have cytologically or histologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver. If the biopsy tissue is not confirmed to be adenocarcinoma of the colon or rectum, the subject will be considered non-evaluable and will be replaced.

MOS will be generated from the study biopsy and a drug screen will be performed to determine sensitivity to standard of care therapy. This method has been proven to have a 75% success rate of generating MOS and testing sensitivity to standard of care therapy from tumor biopsy samples.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kristen Lechleiter, M.S.
  • Phone Number: +1 (984) 377-6738
  • Email: clin-ops@xilis.net

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • The University of Tennessee Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Washington
      • Spokane, Washington, United States, 99208
        • Inland Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will be open to patients in a medical practice of all demographic groups who meet the eligibility criteria.

Description

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

    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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metastatic colorectal cancer
Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
<14 Days from start of MOS generation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the association between standard of care drug sensitivity in MOS to clinical outcome.
Time Frame: 2 - 3 Months post biopsy
The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived from.
2 - 3 Months post biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xilis, Inc.

Investigators

  • Study Director: Kristen Lechleiter, Xilis, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146057.60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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