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RecruitingNCT05324553Updated Jun 9, 2026

Patient Derived Preclinical Models

An observational study in Cancer, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by Mayo Clinic · Observational

From the registry’s dates

  • Started Apr 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study summary

Study goal is to collect tumor specimens that may inform cancer biology to eventually improve outcomes for patients with cancer. This proposal represents a highly collaborative effort to support cancer research with the goal of developing novel therapeutic strategies using patient derived preclinical models.

This study is being done to collect samples of tumor tissues, matched normal tissue when possible, and approximately 50 mL of blood.

Read the detailed description

The objective of this study is to collect tumor specimens (tumor tissues, matched normal tissue when possible, and 50 mL of blood) that may inform cancer biology to eventually improve outcomes for patients with cancer. Additionally, relevant specimens that were previously collected under an IRB approved protocol (13-000942), will be used with approval of the PI of that protocol and patient consent for participation in this protocol.

The collected tissue specimens will be used to develop preclinical models; i.e., cell lines, patient derived micro-cancer models as well as patient-derived xenograft models. In this study we may profile tumors using genomic and/or proteomic approaches to identify targetable alterations in tumor tissue from patients. To assure that the derived cell lines and micro-cancer models have not been cross contaminated during development with other models in development, DNA sequencing may be used. Using these preclinical models, we will test new therapies in vitro, or in vivo in mice in order to identify novel therapeutics as well as interrogate genes for their role in tumor biology. Guidance for molecular targeted therapy will involve gene analysis of oncogenes and tumor suppressor genes. Results from these studies may provide the rationale for the design of future novel clinical trials. The evaluation of these preclinical models may lead to predictive value related to patient response to therapy as well as clinical trials. With consent, these models may be shared with other investigators internal or external to Mayo Clinic.

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Conditions studied

  • Cancer

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Keywords

  • Cancer
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 50 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient population includes anyone 18 years of age and older with cancer who are good medical candidates for standard of care or research biopsy or surgical procedure to obtain tissue.

Inclusion criteria

  • 18 years of age and older
  • Patient is a good medical candidate for a standard of care or research biopsy or surgical procedure to obtain tissue

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
  • Institutionalized or incarcerated patients
  • Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
  • Biopsy must not be considered more than minimal risk to the patient.
  • Have a contraindication to percutaneous biopsy including:

    1. Significant coagulopathy that cannot be adequately corrected.
    2. Severely compromised cardiopulmonary function or hemodynamic instability.
    3. Lack of a safe pathway to the lesion per the interventional radiologist.
    4. Inability of the patient to cooperate with, or to be positioned for, the procedure.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Tissue Collection

    Research tissue specimen will be obtained during the patient's clinical biopsy or clinical tumor resection, if feasible.

    Procedure: Tissue Collection

  • Blood Collection

    Up to 50 mL of research blood will be drawn around the time of the procedure. Additional blood may be collected in selected cases, as warranted, to monitor disease recurrence/remission or perform additional testing

    Diagnostic Test: Blood Collection

  • Buccal Swab

    Buccal swab may be requested, if necessary, to generate germline data.

    Diagnostic Test: Buccal Swab

Interventions

  • ProcedureTissue Collection

    Research tissue specimen will be obtained during the patient's clinical biopsy or clinical tumor resection, if feasible.

  • Diagnostic testBlood Collection

    Up to 50 mL of research blood will be drawn around the time of the procedure. Additional blood may be collected in selected cases, as warranted, to monitor disease recurrence/remission or perform additional

  • Diagnostic testBuccal Swab

    Buccal swab may be requested, if necessary, to generate germline data.

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What researchers measure

Primary outcomes

  1. Number of participants accrued with genomic, microbiome, and drug sensitivity components of aggressive cancer.

    Sequencing data from DNA and RNA will be integrated into a visualization platform to allow individualized study of patient tumor mutations, rearrangements, and RNA expression. Genomically informed analysis will be employed to select potential targets for drug screening in the patient-derived 3D models and determine how many specimens are able to grow as 3D models. In some cases, immunostain results may be analyzed for correlation to RNA expression levels.

    Time frame: Up to 6 years post tissue and blood collection

Secondary outcomes

  1. Determine number of participants with genomic, microbiome and drug sensitivity assays (profile or functional) that suggest changes to treatment plan.

    Sequencing data from DNA and RNA will be integrated into a visualization platform to allow individualized study of patient tumor mutations, rearrangements, and RNA expression. Genomically informed analysis will be employed to select potential targets for drug screening in the patient-derived 3D models. In some cases, immunostain results may be analyzed for correlation to RNA expression levels.

    Time frame: Up to 6 years post tissue and blood collection

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Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05324553
Lead sponsor
Mayo Clinic
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Apr 6, 2022
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Jun 9, 2026

Study contacts

Clinical Trials Referral Office
Contact
mayocliniccancerstudies@mayo.edu
855-776-0015
Tanya M. Schnick
Contact
Schnick.Tanya@mayo.edu
507 293-7582
Aaron S. Mansfield, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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