NCT05189171Completed
MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer
MicroOrganoSphere Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
Source: ClinicalTrials.gov · Last updated 28 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 22 Dec 2021
- Start date
- 25 Oct 2022
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- Xilis, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT05189171
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 25 Oct 2022 to the primary completion date, 3 Nov 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.).
- Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| The University of Tennessee Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Inland Imaging Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| MedStar Washington Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.