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Colorectal NeoplasmsMODEL-CRCNCT05189171

MicroOrganoSphere (MOS) Drug Screen Pilot Trial in Colorectal Cancer

An observational study of Colorectal Neoplasms, run by Xilis, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
MicroOrganoSphere (MOS) drug screen
Type of treatment
Medical device
How many people
46 participants
Where
7 sitesUnited States
Study dates
25 Oct 2022to 18 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • The University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Inland Imaging

    Spokane, Washington, 99208

  • MedStar Washington Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: 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.

Being tested
MicroOrganoSphere (MOS) drug screen
Keywords
Liver Metastasis, Colorectal Cancer, Colon Cancer, CRC liver metastasis, patient-derived model
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MicroOrganoSphere (MOS) drug screenDevice

    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.

Study groups in NCT05189171
Study groupRoleWhat they receive
Metastatic colorectal cancerPatients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.
Receives: Device: MicroOrganoSphere (MOS) drug screen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MOS generation

    Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis

    Measured: <14 Days from start of MOS generation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2022
  2. Study start25 Oct 2022
  3. Primary completion3 Nov 2023
  4. Study completion18 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05189171
Sponsor's protocol ID
146057.60
Acronym
MODEL-CRC
Status last verified
Jun 2024
First submitted
22 Dec 2021
Last updated
28 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Drost J, Clevers H. Organoids in cancer research. Nat Rev Cancer. 2018 Jul;18(7):407-418. doi: 10.1038/s41568-018-0007-6.

    PubMed 29692415

  • Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1.

    PubMed 28248415

  • Andre T, Bensmaine MA, Louvet C, Francois E, Lucas V, Desseigne F, Beerblock K, Bouche O, Carola E, Merrouche Y, Morvan F, Dupont-Andre G, de Gramont A. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol. 1999 Nov;17(11):3560-8. doi: 10.1200/JCO.1999.17.11.3560.

    PubMed 10550155

  • August DA, Sugarbaker PH, Ottow RT, Gianola FJ, Schneider PD. Hepatic resection of colorectal metastases. Influence of clinical factors and adjuvant intraperitoneal 5-fluorouracil via Tenckhoff catheter on survival. Ann Surg. 1985 Feb;201(2):210-8. doi: 10.1097/00000658-198502000-00013.

    PubMed 3970602

  • Stangl R, Altendorf-Hofmann A, Charnley RM, Scheele J. Factors influencing the natural history of colorectal liver metastases. Lancet. 1994 Jun 4;343(8910):1405-10. doi: 10.1016/s0140-6736(94)92529-1.

    PubMed 7515134

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PubMed 15175435

  • Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.

    PubMed 14657227

  • Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.

    PubMed 10493478

  • Fong Y, Cohen AM, Fortner JG, Enker WE, Turnbull AD, Coit DG, Marrero AM, Prasad M, Blumgart LH, Brennan MF. Liver resection for colorectal metastases. J Clin Oncol. 1997 Mar;15(3):938-46. doi: 10.1200/JCO.1997.15.3.938.

    PubMed 9060531

  • Fortner JG. Recurrence of colorectal cancer after hepatic resection. Am J Surg. 1988 Mar;155(3):378-82. doi: 10.1016/s0002-9610(88)80086-2.

    PubMed 3344897

  • Hughes K, Scheele J, Sugarbaker PH. Surgery for colorectal cancer metastatic to the liver. Optimizing the results of treatment. Surg Clin North Am. 1989 Apr;69(2):339-59. doi: 10.1016/s0039-6109(16)44790-0.

    PubMed 2928902

  • Prasad V. Perspective: The precision-oncology illusion. Nature. 2016 Sep 8;537(7619):S63. doi: 10.1038/537S63a. No abstract available.

    PubMed 27602743

  • Marquart J, Chen EY, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Benefit From Genome-Driven Oncology. JAMA Oncol. 2018 Aug 1;4(8):1093-1098. doi: 10.1001/jamaoncol.2018.1660.

    PubMed 29710180

  • Meric-Bernstam F, Brusco L, Shaw K, Horombe C, Kopetz S, Davies MA, Routbort M, Piha-Paul SA, Janku F, Ueno N, Hong D, De Groot J, Ravi V, Li Y, Luthra R, Patel K, Broaddus R, Mendelsohn J, Mills GB. Feasibility of Large-Scale Genomic Testing to Facilitate Enrollment Onto Genomically Matched Clinical Trials. J Clin Oncol. 2015 Sep 1;33(25):2753-62. doi: 10.1200/JCO.2014.60.4165. Epub 2015 May 26.

    PubMed 26014291

  • Schwaederle M, Zhao M, Lee JJ, Lazar V, Leyland-Jones B, Schilsky RL, Mendelsohn J, Kurzrock R. Association of Biomarker-Based Treatment Strategies With Response Rates and Progression-Free Survival in Refractory Malignant Neoplasms: A Meta-analysis. JAMA Oncol. 2016 Nov 1;2(11):1452-1459. doi: 10.1001/jamaoncol.2016.2129.

    PubMed 27273579

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Neoplasms, run by Xilis, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MOS generation (time frame: <14 Days from start of MOS generation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05189171, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.

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