Patient Derived Preclinical Models

• ClinicalTrials.gov Identifier: NCT05324553
• Recruitment Status: Recruiting
• First Posted: April 12, 2022
• Last Update Posted: May 13, 2022
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Procedure: Tissue Collection; Diagnostic Test: Blood Collection; Diagnostic Test: Buccal Swab	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment

Intervention Model Description

Tumor Tissue: A research tissue specimen will be acquired during the patient's clinical biopsy or clinical tumor resection, if accessible and feasible for research collection. Tissue will be collected on up to 50 participants. The research team will request that additional tissue be obtained in addition to the sample required for the clinical procedure, such that the tissue will be for research purposes only.

Blood Samples: Up to 50mL (approximately 3 tablespoons) will be drawn prior to or after surgical biopsy. Additional blood may be collected in selected cases, as warranted, to monitor disease recurrence/remission or perform additional testing no more than every 6 weeks. The blood may be collected with a regularly scheduled clinical draw or be ordered as a research only collection.

Buccal Swab: Additionally, the buccal mucosa may be swabbed to obtain material to generate germline DNA.

Clinical Residuals: Residual waste specimens from clinical procedures may be obtained.

• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Patient Derived Preclinical Models
• Actual Study Start Date: April 6, 2022
• Estimated Primary Completion Date: March 31, 2027
• Estimated Study Completion Date: March 31, 2028

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Tissue Collection; Research tissue specimen will be obtained during the patient's clinical biopsy or clinical tumor resection, if feasible.	Procedure: Tissue Collection; Research tissue specimen will be obtained during the patient's clinical biopsy or clinical tumor resection, if feasible.
Active Comparator: 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; 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
Buccal Swab; Buccal swab may be requested, if necessary, to generate germline data.	Diagnostic Test: Buccal Swab; Buccal swab may be requested, if necessary, to generate germline data.

Outcome Measures

Primary Outcome Measures :

1. Number of participants accrued with genomic, microbiome, and drug sensitivity components of aggressive cancer. [ Time Frame: Up to 6 years post tissue and blood collection ]
   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.

Secondary Outcome Measures :

1. Determine number of participants with genomic, microbiome and drug sensitivity assays (profile or functional) that suggest changes to treatment plan. [ Time Frame: Up to 6 years post tissue and blood collection ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Clinical Trials Referral Office; 855-776-0015; mayocliniccancerstudies@mayo.edu

Contact: Tanya M. Schnick; 507 293-7582; Schnick.Tanya@mayo.edu

Locations

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator: Aaron S. Mansfield, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Aaron S. Mansfield, M.D.; Mayo Clinic

More Information

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05324553
• Other Study ID Numbers: 21-008831; NCI-2022-02445 ( Other Grant/Funding Number: NCI )
• First Posted: April 12, 2022
• Last Update Posted: May 13, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mayo Clinic:

Cancer