Clinical trial NCT05189171: MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer
Official title: MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Liver Metastasis
Colorectal Cancer
Colon Cancer
CRC liver metastasis
patient-derived model
Lead sponsor: Xilis, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MOS generation
timeFrame: <14 Days from start of MOS generation
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Washington
country: United States
facility: MedStar Washington Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Knoxville
country: United States
facility: The University of Tennessee Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Spokane
country: United States
facility: Inland Imaging
state: Washington
Study officials:
affiliation: Xilis, Inc.
name: Study Official
role: STUDY_DIRECTOR
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