Clinical trial NCT05324553: Patient Derived Preclinical Models
Official title: Patient Derived Preclinical Models
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Number of participants accrued with genomic, microbiome, and drug sensitivity components of aggressive cancer.
timeFrame: Up to 6 years post tissue and blood collection
Secondary outcomes:
measure: Determine number of participants with genomic, microbiome and drug sensitivity assays (profile or functional) that suggest changes to treatment plan.
timeFrame: Up to 6 years post tissue and blood collection
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Aaron S. Mansfield, M.D.
role: PRINCIPAL_INVESTIGATOR
References: