Patient Derived Preclinical Models

NCT05324553 | Recruiting

• 1 other identifier: 21-008831
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer

Outcome Measures

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.

  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.

  Up to 6 years post tissue and blood collection

Study Arms (3)

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

Tissue Collection PROCEDURE

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

Tissue Collection

Blood Collection DIAGNOSTIC_TEST

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

Blood Collection

Buccal Swab DIAGNOSTIC_TEST

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

Buccal Swab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Neoplasms

Interventions

Tissue Banks; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Biological Specimen Banks; Health Facilities; Health Care Facilities Workforce and Services; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aaron S. Mansfield, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Tanya M. Schnick

CONTACT

507 293-7582; Schnick.Tanya@mayo.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 12, 2022
• Study Start: April 6, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)